The FDA classified the recall of some angiographic guidewires made by Medtronic (NYSE:MDT) as Class I, the most serious kind.
Medtronic’s angiographic guidewire component affected by the recall helps place catheters into the vasculature during angiography or other interventional procedures.
According to an FDA notice, the recall occurred because devices were not sterilized before being shipped directly to hospitals. Should patients experience exposure to the non-sterile device, serious adverse events including infection, sepsis and death may occur.
No injuries or deaths have been reported in relation to the issue, which has been the subject of two complaints. The FDA notice says there is potential for underreporting as physicians may not have been aware that the devices were non-sterile.
Medtronic initiated the recall on May 4, 2021, and it encompasses guidewires distributed between Nov. 23, 2007, and March 29, 2021. In total, the company recalled 54,997 devices in the U.S.
The company’s urgent medical device recall letter sent out on May 4 instructed users to identify and quarantine all unused, affected lots of angiographic guidewire components:
- Model Numbers:
- WIRE ANGIO 107042 PNS .035X145 3MMJ PTFE; Part No: 107042
- WIRE ANGIO 107044 PNS .038X145 3MMJ PTFE; Part No: 107044
- WIRE ANGIO 107447 PNS .035X145 3MMJ PTFE; Part No: 107447
- WIRE ANGIO 110003 PNS .035C145 3MMJ PTFE; Part No: 110003
- WIRE ANGIO 110004 PNS.038X145 3MMJ LTPTF; Part No: 110004