Hello, and welcome to Recall Roundup, your go-to source for information about medical device malfunctions and FDA recalls!
Recalls range from tweaking smaller issues to pulling a device 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 agency posts a list of Class I recalls on its website after the manufacturer takes action. The agency also posts early alerts for potential high-risk recalls or corrections as part of a new pilot program announced Nov. 21.
During January, the FDA posted nine Class I medical device recalls and one early alert.
Endoscopic vessel harvesting (EVH) correction. Getinge and Maquet updated instructions for their VasoView HemoPro 2 (VH-4000 and VH-4001) EVH systems in December 2024, after reports of heater wires becoming bent or detached and silicone peeling or detaching from the harvest tool during use. There have been seven serious injuries reported, the FDA said on Jan. 15. This follows similar complaints featured in November’s Recall Roundup about other versions of the VasoView device.
Endoscope forceps/irrigation plug recall. Olympus recalled all lots of the MAJ-891 forceps/irrigation plug (isolated type) in a Dec. 18 advisory. Olympus has reported 120 injuries and had one report of death due to infection following procedures for using the MAJ-891 with a cystoscope (CYF scope), the FDA reported Jan. 31.
Extracorporeal blood circuit issue. Following an early alert in December, the FDA on Jan. 31 confirmed a recall of several lots of Nuwellis’s AquaFlexFlow UF 500 Plus extracorporeal blood circuit. The set—part of a therapy that removes excess fluid from a patient’s blood—is prone to setting off alarms during use that then trigger the end of therapy. There have been three reported injuries.
Fluid fumbles. Medline warned users on Dec. 16 that some lots of its fluid delivery sets were assembled incorrectly and shouldn’t be used. The sets regulate IV flow rate and prevent air from entering IV tubing. The incorrect sets were made with white macro drip chambers, which deliver much more fluid than the required gray micro drip chambers, putting patients at risk of overdose. There have been no injuries. This was an update to an earlier alert.
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Gas-powered emergency resuscitator recall. On Dec. 5, Mercury Medical warned users to quarantine some lots of its T-Piece resuscitator (Neo-Tee). There’s a small spring in the controller that can keep the device from providing enough breathing support. There have been no deaths or injuries reported, the FDA shared on Jan. 31.
Glucose and glucose/ketone meter correction. Nova Biomedical Corporation updated a software bug in its StatStrip meters that measure glucose and ketones in a patient’s blood, after learning that incorrect measurements were being sent to hospital medical record systems. The FDA noted in a Jan. 30 notice that users should “be aware” of the issue but “no action is needed” because meters have already received software updates. There have been no reported deaths or injuries.
Infusion pump issue. In a Jan. 31 update to a December alert, the FDA reported it has confirmed a recall for some Fresenius Kabi USA Ivenix large-volume pumps. Fresenius Kabi told customers on Dec. 5 that some of the pumps would be removed for pneumatic valve repair following a malfunction. There have been no known deaths or injuries.
Monitoring service application for mobile cardiac outpatient telemetry correction. As of Jan. 13, the FDA knows of 109 reported injuries and two deaths after a Philips application that monitors patient electrocardiograms (ECGs) failed to properly alert health professionals about serious cardiac events, like atrial fibrillation, supraventricular tachycardia, and ventricular tachycardia. Philips and its subsidiary Braemar Manufacturing—creators of the monitoring service application software—sent users correction instructions on Dec. 18, including how to identify which patients have been affected.
Nephroscope sheath issue. The FDA gave a Jan. 31 update on an earlier alert, sharing that Trokamed GmbH has changed use instructions for its device, which is designed to bring instruments, telescopes, and fluids to surgical sites. The new instructions clarify that the sheath should not be used as a suction or irrigation device. There’s been one reported death after the device was used this way.
Early alert. The FDA also issued an early alert for more potential issues with infusion pump software from Fresenius Kabi USA.