Medtronic has recalled approximately 6,000 IN.PACT Admiral catheters and three IN.PACT AV catheters, the company announced Thursday.
This is a voluntary recall due to potential pouch damage that could result in a loss of sterility. The issue, identified during a routine inspection, was attributed to “a change implemented to one manufacturing line.”
“All batches manufactured on this line after that change are being retrieved,” according to an advisory from Medtronic. “The problem on that line was fixed. Additionally, to ensure no further issues, production on all lines was paused until a follow up packaging inspection was completed. No further errors were discovered.”
The company has received no complaints about the identified issue at this time.
Any healthcare providers with these paclitaxel-coated percutaneous transluminal angioplasty balloon catheters on hand are asked to return them to Medtronic. No actions are necessary for patients treated with these solutions.
“No other Medtronic products are affected by this issue,” the company added. “All appropriate regulatory bodies have been notified.”
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Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.