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.
Welcome to August’s Recall Roundup!
Access system issue. 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.
Infusion issue. 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.
Lightless laryngoscopes. 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.
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Power problems. 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.
Reprocessed recall. 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.
Stent issue. 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.
To filter or not to filter? 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.
Ventilator warning. 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.