Endologix recalled its AFX Introducer System back in May, and now the FDA has assigned its most serious warning to the catheter-insertion device, saying it could cause serious injury or death.
Cook Medical's ongoing recall of its Zilver PTX stent could be a costly one.
The FDA has affixed its most serious warning to Cook Medical's recall of the Zilver PTX stent, warning that problems with the device's delivery catheter could lead to thrombosis, amputation or death.
In April, Abbott Laboratories announced it was yanking the FreeStyle InsuLinx blood glucose meters off the U.S. market, and now the FDA has assigned its most-serious Class I label to the effort, warning that the devices' malfunction could lead to serious injury or death.
Medtronic is following through on its long-held plans to slash jobs in its spinal business, cutting 230 positions as revenues falter. Meanwhile, the FDA slapped its most serious recall label over a potentially deadly flaw with the device giant's deep-brain stimulators.
Last month, Covidien launched a recall of battery packs used with its Newport HT70 ventilators, and now the FDA has assigned its most serious designation to the problem, warning that the malfunctioning batteries could lead to injury or death.
Cook Medical has launched a global recall for its banner Zilver PTX stent, warning that a small number of the devices broke from their delivery catheters during implantation, a problem that has already led to one death.
Last month, Johnson & Johnson voluntarily recalled three models of its market-leading LifeScan glucose meters, and now the FDA has slapped a Class I label on the stateside effort, warning that use of the device could lead to serious injury or death.
CareFusion was plagued by regulatory problems all last summer, and now the company is reporting an issue with another model of its Alaris infusion pumps, earning the FDA's most-serious warning.
Covidien is recalling certain battery packs used with its Newport HT70 ventilators, warning that they may fail to charge or revert to emergency backups, putting patients at risk for adverse events.