Healthcare Brew covers pharmaceutical developments, health startups, the latest tech, and how it impacts hospitals and providers to keep administrators and providers informed.

Healthcare Brew

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Caroline Catherman

Healthcare Brew delivers the latest news and trends in healthcare.

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Every year, the FDA gets 2+ million reports of deaths, injuries, and malfunctions suspected to be linked to medical devices.

Sometimes, these incidents are one-offs. But they can also be a sign of a bigger problem. In these cases, companies warn providers to change how they use these devices or stop using them altogether. The FDA categorizes many of these incidents as recalls, which range from Class III (least dangerous) to Class I (most dangerous).

Whether you’re a doctor double-checking if the devices you use are affected or someone merely curious about how multimillion-dollar technological innovations can go wrong, we’re keeping you informed on some of those Class I recalls here in our monthly (noncomprehensive) series.

Boston Scientific has issued guidance on reducing the risk of air embolisms when using its Watchman access systems. As of July 30, Boston Scientific reported 120 serious injuries and 17 deaths linked to this issue, according to an FDA release current as of Aug. 6.

 The Plum Duo Infusion System’s user interface may stop responding in certain circumstances, ICU Medical warned customers in a letter that included troubleshooting instructions.

Some handles on Flexicare Medical’s BritePro laryngoscopes aren’t illuminating like they’re supposed to. The company told users to check if their device handles light up and return them if they don’t.

Abbott has informed customers some power cords for mobile power units that connect to its HeartMate blood pump may not properly lock into place, potentially disconnecting the power source from the pump.

Medline’s medical device reprocessing program, Medline ReNewal, says some lots of its reprocessed versions of St. Jude Medical’s Response and Supreme electrophysiology catheters may be contaminated with “small residual particulates.” Medline is asking customers to notify the company and quarantine any affected lots.

Boston Scientific is removing some batches of the carotid Wallstent monorail endoprosthesis closed cell self-expanding stent and accompanying pieces, the company said in a letter after providers reported it was difficult to withdraw the stent delivery system.

 This one is simple enough: The Microbore extension set with 0.2 micron filter has a label saying it includes an air-eliminating filter. It doesn’t. It has a filter, but not an air-eliminating one, B Braun Medical said in a letter to users.

Certain serial numbers of printed circuit boards for the Hamilton-C6 ventilator need replacement. The boards have a defect that could cause the ventilator to fail before it starts up or even interrupt ventilation, according to Hamilton Medical AG.

Mashup of hospital symbol, stethoscope, IV bag, oxygen tank, and other medical devices on orange background

Recall Roundup: August 2025

Paging all providers: Change how you use these devices, stat!

The number of FDA-cleared artificial intelligence-enabled medical devices has 

 in 2023 to 1,247 as of Aug. 28, according to the federal agency’s 

And healthcare systems are getting on board. In a 

, about 88% of 233 health system executives said their system uses AI.

Though only a small percentage have been recalled, 60 AI-enabled devices racked up 182 recorded recall events as of November 2024, according to an Aug. 22 JAMA 

Throughout these recalls, there was a consistent thread: Publicly traded companies’ devices (about 92%) were recalled more frequently than private companies’ devices (53%).

“That was really something we were surprised by because we were thinking public companies probably have better risk management,” Tinglong Dai, Bernard T. Ferrari professor at the Johns Hopkins University Carey Business School and one of the paper’s authors, told Healthcare Brew.

The paper theorizes public companies could feel pressure from investors to put out devices as quickly as possible, perhaps not giving them time for more thorough research.

“Investors, they want to see year after year you have new AI devices cleared by the FDA, you have AI devices being rolled out among healthcare providers, so the pressure itself might have contributed to the recalls,” Dai said. 

There were several main reasons for the recalls—a designation that ranges from a quick software update to total market removal—with 109 recalled due to diagnostic or measurement errors, 44 for a functionality delay, 14 for physical hazards, and 13 for biochemical hazards.

“If you have a misdiagnosis, obviously the entire healthcare delivery could be subject to risk because wrong diagnosis means that you could also have the wrong treatment,” Dai said.

The research letter identified another pattern, too. The majority (40% from the private companies, 78% from established public companies, and 97% from smaller public companies) of the recalled devices weren’t clinically validated before they were approved.

 are given the greenlight through the FDA’s 510(k) pathway, which clears a device if it proves it is “substantially equivalent” to a previously cleared device. Clinical data is not normally required to get an OK via a 510(k), as opposed to other clearance processes.

This is something health systems and providers should keep in mind when deciding 

“From the user’s perspective, I think it’s extremely important to understand…the difference between reported performance and real-world performance,” he said.

Even AI programs with strong premarket clinical data “frequently” perform worse in diverse real-world clinical settings, according to a March 2025 

This is one of the reasons the American Medical Association uses the term “augmented intelligence” rather than “artificial intelligence,” according to the organization’s website. AMA 

 says that AI is not supposed to call the shots or operate without oversight by a human healthcare professional.

A Department of Health and Human Services spokesperson told Healthcare Brew the agency “is not able to confirm” the numbers cited in the JAMA study, but “remains committed to ensuring patients have access to safe and effective medical devices, including those enabled with AI.”

In addition to general device software validation and safety requirements, the agency released 

 in January specifically for AI-enabled devices, like what data and documentation is needed to show safety and effectiveness.

Tinglong Dai’s title has been clarified.

Pill capsule with tech system inside, slightly open, and a honeycomb-like web in the background

Over 90% of recalled AI-enabled medical devices were from public companies

Though only a few AI-enabled devices have been recalled, patterns are emerging.

Are you curious about all the ways multimillion-dollar medtech can go wrong?

If so, welcome to Recall Roundup, where we keep our eyes on the FDA’s recent medical device recalls.

First, a company takes action, then the FDA categorizes that action as a recall from Class III (least dangerous) to Class I (most dangerous) and summarizes those recalls in weekly enforcement reports, which also include early alerts for things that may be recalled later on.

Without further ado, below is a noncomprehensive list of recent Class I recalls.

Getinge subsidiary Maquet Critical Care AB has updated instructions for all of its Servo-u, Servo-n, and Servo-u MR ventilators due to an error that could result in a difference between the volume of oxygen delivered and the volume displayed.

Edwards Lifesciences has pulled several lots of its OptiSite arterial perfusion cannula, a device used during cardiopulmonary bypass procedures, as there have been a few instances where a wire separates from the device.

Medtronic has pulled certain lot numbers of the Bravo CF capsule delivery device, which delivers a capsule that monitors the pH of a patient’s esophagus. But a misapplied adhesive on the delivery device sometimes keeps the capsules from properly and safely attaching, the FDA reported.

Abiomed updated instructions for the controller to its Impella heart pump. The manufacturer said sometimes the control doesn’t detect the pump when it connects.

AirLife and Vyaire are pulling AirLife infant heated wire circuits, used to support ventilation, because they can potentially disconnect unexpectedly, according to the recall.

Baxter Healthcare Corporation gave customers new instructions for its Novum IQ large volume pumps after reports of over and underinfusions of fluids.

Certain lot numbers of Intersurgical’s i-view video laryngoscope are being pulled because of a potential for the devices’ batteries to become depleted, resulting in faulty performance, the FDA reported.

 An optional component for machines that lift patients up might not attach properly, risking patients falling to the ground. Baxter Healthcare Corporation warned consumers to not use the part.

 Some versions of AirLife’s Broselow Rainbow Tapes—a color-coded tape that provides treatment recommendations based on a child’s height and weight—have incorrect measurement values, the company reported in its recall.

Correction 08/05/2025: This story has been updated to clarify that Baxter Healthcare Corporation

gave customers mitigating instructions for using its

recalled Novum IQ large volume pumps; the company did not warn users to discontinue use, as stated in the original story.

Recall Roundup: FDA medical device recalls in July 2025

Recalled devices include infusion pumps and an esophageal pH monitoring capsule.

Sarepta Therapeutics is laying off 36% of staff—500 employees—a move expected to be “substantially completed” by the end of Q3, it announced in a July 16 

As part of these changes, the company is scrambling its C-suite:

The company is terminating Dallan Murray, EVP and chief customer officer, though he will remain a consultant through January 2026.

Ian Estepan, former EVP and CFO, is now president and chief operating officer.

Former president and CEO Douglas Ingram will solely be CEO from now on.

Ryan Wong has taken over Estepan’s old positions.

Louise Rodino-Klapac is now the company’s president of R&D and technical operations. She was previously EVP and chief scientific officer, and headed R&D.

Sarepta will also add a black-box warning—the most serious kind—for acute liver injury and failure for Elevidys, per the FDA’s request. Elevidys, the company’s most profitable product, is the only FDA-approved gene therapy for deadly muscle-wasting disease Duchenne muscular dystrophy.

Elevidys has been somewhat controversial since its June 2024 approval.

Then-director of the Center for Biologics Evaluation and Research Peter Marks overruled his staff to give the drug full approval for ambulatory patients ages 4+ and accelerated approval to nonambulatory patients.

This happened even though the FDA’s clinical and clinical and clinical pharmacology review team wrote it had “no satisfactory data to support effectiveness claims for all ages and for nonambulatory patients,” 

In the year since the drug’s approval, two nonambulatory patients taking Elevidys died of acute liver failure. One case was disclosed in 

After the second death, Sarepta announced it was pausing shipping Elevidys to nonambulatory patients.

Sarepta added in its July 16 update that an internal expert committee has devised an “enhanced immunosuppressive regimen” for nonambulatory patients to take in order to reduce their chances of acute liver failure.

The company plans to submit that to the FDA and start gathering evidence on how to safely resume the treatment in patients who can’t walk.

In total, more than 900 people have taken the drug worldwide, according to the company.

the Sarepta Therapeutics company logo is seen displayed on a smartphone screen.

Sarepta to cut 36% of staff, add black-box warning to Elevidys

The layoffs come after two deaths of patients who had taken its most profitable product, Elevidys. 

Are you curious about all the ways that multimillion-dollar medtech can go wrong?

If so, you’re in the right place!Welcome to Recall Roundup, a noncomprehensive roundup of recent FDA Class I recalls—the most severe and potentially life-threatening kind. Recalls range from correcting an issue to removing a device from the market altogether.

Blood products administration set recall.

 Fresenius Kabi has pulled an incorrectly assembled line of its Ivenix LVP Blood Products Administration Set. If used, patients could be infused with unfiltered blood.

Cook Medical wants customers to return certain Cook Beacon Tip 5.0 Fr angiographic catheters because the tip is at risk of detaching.

Medline told customers to stop using and destroy certain lots of neonatal and pediatric convenience kits that contain recalled Smiths Medical endotracheal tubes. The company said the tubes are too small and could cause underventilation.

Some Dexcom G6, G7, One, and One+ glucose receivers with certain serial numbers may have receivers that weren’t correctly assembled and should be returned.

Zyno Medical asked customers to stop using certain lots of its Z800WF Infusion System because “unreleased software versions” were installed “without verification or validation.”

Medtronic is asking customers to replace certain models of its Newport HT70 series ventilators and control boards. They have defects that can cause the ventilator to shut down during use or otherwise malfunction.

assortment of various medical devices around a teal healthcare symbol

Recall roundup: FDA medical device recalls during June 2025

Pulled devices include ventilators and infusion systems.

Hospitals and third-party companies have long been cleaning, retesting, and reusing medical devices, including those labeled as single-use, an approach known as “reprocessing.”

Often, this can help cut down medical waste and save money, and it doesn’t appear to compromise safety: As of 2000, the FDA requires reprocessed devices to meet the same formal regulatory standards of the original products, including premarket testing.

In 2008, the Government Accountability Office 

 that “the available data, while limited, do not indicate that reprocessed [single-use devices] present an elevated health risk.”

However, the use of these refurbished devices still faces resistance from original manufacturers, who profit more from the devices being disposed of after one use or reprocessing devices themselves, according to a 

The medical reprocessing industry hopes a recent court ruling may change that.

On May 16, a California jury unanimously found Biosense Webster—now Johnson & Johnson Medtech—violated antitrust laws by not providing the same clinical support for one third-party company’s reprocessed version of catheters that it does for new versions.

Then on June 5, the damages were automatically tripled, increasing J&J Medtech’s penalty for this violation from $147 million to $442 million in damages. The pharma giant must pay this out to the company that brought the suit, Innovative Health.

“Going forward, given this is such a big verdict, my hope is that the larger medtech industry will work with us instead of against us,” Dan Vukelich, president of trade group the Association of Medical Device Reprocessors, told Healthcare Brew.

J&J Medtech rejected these claims. “We strongly disagree with the jury’s verdict and believe it will not withstand appellate review. In the meantime, we will comply with the ruling and any court-ordered relief pending the outcome of the appellate process,” J&J spokesperson Madeline Nafus told Healthcare Brew.

The lawsuit was brought by Innovative Health, a company based in Arizona that reprocesses J&J Medtech catheters for electrophysiology studies, which measure heart activity in order to diagnose abnormal heart rhythms.

J&J Medtech sells its catheters as single-use devices to hospitals. The FDA had also approved Innovative Health to reprocess and sell used catheters back to hospitals for one to three more uses in 2009, according to Innovative’s complaint.

But the suit alleges J&J Medtech policies have penalized hospitals that use Innovative Health’s reprocessed versions. 

For instance, the catheters can only be used with a specific J&J brand cardiac mapping system that requires clinical support to operate. J&J Medtech offers free clinical support to providers, but about 10 years ago, it started withholding that clinical support when providers used reprocessed catheters from Innovative Health, the suit alleges.

It’s important to make reprocessing easier in order to cut down on medical waste and patch medical device supply chain 

“This case is an opportunity for us to highlight with our healthcare provider partners or hospitals and surgical centers that they don’t need to tolerate this anymore. They should forcefully push back—and now more than ever,” he said.

Exterior view of Johnson & Johnson MedTech's office in Santa Clara, California.

Medical reprocessing industry hopes J&J verdict brings reform 

The pharma giant was ordered to pay $442 million. 

There’s a cybersecurity problem breathing down the healthcare industry’s neck. 

On April 7, Baxter Healthcare pulled all 4,100+ Welch Allyn Life2000 ventilators due to severe cybersecurity concerns. The FDA labeled this a Class I 

, meaning these issues threatened patients’ lives, though the agency hasn’t reported any injuries or deaths.

Naomi Schwartz, a former FDA employee and VP of services for MedCrypt, a cybersecurity firm for medical device manufacturers, told Healthcare Brew this recall should be a lesson for the medical technology industry.

This is one of several device recalls in recent years prompted by 

, and in her opinion, Baxter did the right thing fast. The global medtech company first flagged these weaknesses in November, noting that there hadn’t been any hacks up to that point. An April market removal is a relatively short turnaround, she added.

But the vulnerabilities were easily avoidable with a development framework known as 

, the idea that companies—not consumers—are responsible for cybersecurity, and products should have features like multi-factor authentication.

On a scale of “you have to have a PhD” to “a teenager” could hack the system, Baxter’s ventilator security was more toward the latter, Schwartz said. Let’s run through some of the issues:

 For one, the ventilators didn’t encrypt sensitive information, like passwords, according to Baxter’s November 

. “If I’m just issuing all my data in plain text, that’d be like me sending you an email saying, ‘Hey, my front door is unlocked. Walk into my house, why don’t you?’” Schwartz said.

 All a hacker needed to do to access the device was walk into a hospital and plug a piece of hardware into a physical port on the ventilator, Schwartz explained.

 The software used to test and calibrate the ventilators didn’t require authentication from the user either, so anyone could have tweaked the ventilator settings. This flaw was severe enough to earn a score of 10/10

on a scale used by the government to measure vulnerabilities—“a nightmare scenario,” Schwartz said.

These issues should prompt other companies to double-check their own ventilators’ security—especially 

 that were made many years ago, Schwartz said. 

“These are very common problems, and they’re all things that a secure-by-design set of practices would have prevented,” she said.

The good news is Schwartz thinks Baxter responded quickly and appropriately once it discovered these flaws. 

“The people out there who are producing and selling these products are doing their due diligence. They’re going back and checking older systems. They’re making sure that things are good and secure, and when they’re not, they’re taking appropriate action,” she said.

This incident comes after the FDA and Congress have 

 medical device cybersecurity requirements in recent years. 

For instance, in March 2023, the Protecting and Transforming Cyber Healthcare Act started requiring medical device manufacturers to address cybersecurity requirements in their submissions for market approval.

Healthcare symbols over a red binary background

FDA