Medtronic recalls Paclitaxel-coated PTA balloon catheters with packaging that may lose sterility, risking infection during procedures. Affected units include specific lot numbers and model codes.
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Medtronic is recalling Paclitaxel-coated PTA balloon catheters that may have damaged packaging, leading to loss of sterility. This could cause infections during medical procedures if the catheter is used without proper sterility.
Damaged packaging could allow contamination, leading to loss of sterility. This might cause infections during medical procedures if the catheter is used without proper sterility.
Healthcare professionals using the Medtronic IN.PACT AV catheter for procedures. Patients receiving the catheter during medical treatments are at risk if the packaging is compromised.
Check for the lot number 0010990608 and GTIN 00763000232580 on the packaging. The product is a Paclitaxel-coated PTA balloon catheter with the reference code IAV06008008P.
Inspect the packaging for signs of damage that could compromise sterility.
The recall indicates packaging may be damaged, risking loss of sterility. Do not use if packaging is compromised.
The recall does not specify a remedy, so check packaging for damage and contact Medtronic for guidance.
Look for lot number 0010990608 and GTIN 00763000232580 on the packaging.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1043-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1043-2022 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
