Medtronic recalls specific IN.PACT Admiral balloon catheters due to potential packaging damage causing loss of sterility. Affected models include ADM04004013P and others listed. No remedy specified in recall notice.
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Medtronic is recalling certain IN.PACT Admiral balloon catheters because their packaging might get damaged, which could lead to loss of sterility. This means the catheters might not be safe for medical use if the packaging is compromised.
The packaging for these balloon catheters may become damaged during manufacturing or shipping, which could cause the catheters to lose their sterility. If the catheters are not sterile, they could cause infections or other complications during medical procedures.
Healthcare professionals who use these specific catheter models in medical procedures are most at risk. Patients receiving these catheters during procedures could be affected if the packaging is damaged.
Check the model numbers listed in the recall notice: ADM04004013P, ADM04008013P, ADM04012013P, and others. The lot numbers and GTINs are also provided for identification.
Look for the model numbers listed in the recall notice: ADM04004013P, ADM04008013P, ADM04012013P, and others.
The packaging for these balloon catheters may be damaged, which could result in loss of sterility.
The affected models include ADM04004013P, ADM04008013P, ADM04012013P, and others as listed in the recall notice.
The recall notice does not specify any remedy.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1042-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1042-2022 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.
