Medtronic Recalls IN.PACT Admiral and IN.PACT AV Catheters
The company says there is potential pouch damage from a production-line problem, which could result in loss of sterility.
A production line issue that has since been corrected has resulted in the voluntary recall of 6,000 IN.PACT Admiral catheters and three IN.PACT AV catheters, Medtronic announced today.
According to the company, a change implemented to one manufacturing line resulted in potential damage to pouches that keep the paclitaxel-coated devices sterile.
“All batches manufactured on this line after that change are being retrieved. 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,” Medtronic said in a press release announcing the recall.
There have been no complaints involving the issue or any reports of injury or death related to the manufacturing error.
L.A. McKeown is a Senior Medical Journalist for TCTMD, the Section Editor of CV Team Forum, and Senior Medical…
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- US Food and Drug Administration. Medtronic issues voluntary recall for subset of IN.PACT Admiral and IN.PACT AV drug coated balloon due to pouch damage. Published and Accessed on: March 31, 2022.
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