Recall Roundup: FDA medical device recalls during February

Curious about all the ways that multimillion-dollar medical tech can go wrong? You’re in the right place.

Welcome to Recall Roundup, where we keep you updated on medical device recalls that the FDA has posted over the last month.

Recalls range from correcting smaller issues to yanking devices from the market altogether. They are ranked from Class III, which means a product violates FDA law but is “not likely” to be a health hazard, to Class I, which means the product poses a high risk of serious injury or death.

The FDA posts a list of new Class I recalls on its website after the manufacturer takes action, along with early alerts for things that may be labeled Class I recalls later on.

The FDA posted 12 new medical device recalls and one early alert in February.

Ablation catheter update. Varipulse, a new ablation catheter (heart rhythm) device, received FDA approval in November then slowly rolled out in the US. But after four patients had strokes or mini strokes, manufacturer Biosense Webster and parent company Johnson & Johnson paused US sales on Jan. 5. The latest update: On Feb. 14, the companies updated use instructions and resumed sales.

Arterial catheter recall. On Dec. 31, Medline Industries pulled certain lots of integrated arterial catheters from the market due to “excess material” at the catheter hub that could detach and enter patients’ bloodstream. The good news: There have been no injuries or deaths, the FDA reported on Feb. 6.

Breathing circuit kit recall. Sentec/Percussionaire has recalled its VDR4 Phasitron breathing circuits because of malfunctions that could reduce pressure and volume flow, hindering ventilation. The company advises healthcare providers to closely monitor patients using these circuits and discontinue using any malfunctioning devices. There have been no injuries or deaths reported, the FDA reported on Feb. 10.

Continuous ventilator correction. Baxter Healthcare Corporation warned customers in December that its Life2000 ventilator systems have battery charger defects. The company is providing replacement chargers and helping facilities return defective ones. No deaths or injuries have been reported, the FDA said on Feb. 5.

Endoscope instrument recall. The good news: No deaths have been reported. The bad news: There have been 26 serious injuries reported after the tip of Olympus’s single-use guide sheath “fell off into the patient.” Olympus pulled several model numbers from use on Jan. 15, and the FDA deemed it a Class I recall on Feb. 28.

Heart pump update. On Dec. 12, Abiomed updated usage instructions for its Impella RP with SmartAssist and Impella RP Flex with SmartAssist heart pumps after discovering that guidewires or other devices might accidentally touch the pump during procedures, potentially causing it to pause or stop. No injuries or deaths have been linked to this issue, the FDA reported on Feb. 14.

Newborn kit recall. The FDA shared on Feb. 28 that ROi, a supply chain solution company, has recalled certain lots of newborn kits that contain Mercury Medical’s Neo-Tee T-piece resuscitator, which was pulled from market and deemed a Class I recall on Jan. 31. Luckily, there have been no reported injuries or deaths associated with this recall.

Oxygen concentrator recall. Jiangsu Jumao X-Care Medical Equipment has recalled its JMC5A Ni/TruAire-5 oxygen concentrators due to reports of melting and fires during use. While no injuries or deaths have been reported, melting and fires are obviously not ideal. In a November letter, the company urged customers to replace or return the affected concentrators, and said it is investigating the cause.

Patient table advisory. Philips has updated the instructions for its Allura and Azurion systems’ patient tables after finding that an incorrectly positioned mattress can cause patients to fall from tables. There have been five reported injuries, the FDA reported on Feb. 28.

Power assist device recall. Max Mobility, in collaboration with Permobil, warned providers to stop using the SpeedControl dial component on SmartDrive power assist devices. An issue with the circuit board can knock the device out of control, and it may start moving on its own, turn off, or fail to start. There have been 13 injuries, the FDA reported on Feb. 28.

Pressure monitoring device recall. In November 2024, Medtronic Neurosurgery warned that its Becker and Exacta external drainage and monitoring systems may crack or leak, leading to infections or death. There have been 15 injuries and no deaths reported, the FDA shared on Feb. 3.

Early alerts. The FDA issued an early alert about an atherectomy catheter system issue from Bard Peripheral Vascular.