Medtronic recalls Protege GPS Self-Expanding Peripheral Stent System (product number SERB65-09-60-80) due to potential packaging seal defects that could compromise sterility. Affected units include lot B644679 with UDI-DI 00643169728974.
Seal defects could compromise the ability of the product packaging to maintain sterility.
Medtronic is recalling a specific stent system because its packaging might have seal defects that could allow contamination. This could lead to infections if the device is used without proper sterility.
The packaging seal defects could allow contaminants to enter the sterile product, potentially causing infections during medical procedures. This risk exists because the product is used in sterile environments where contamination could lead to serious complications.
Patients who received this stent during surgery between 2021 and 2023 are likely affected. Medical professionals using the product for procedures are at risk if they handle it without proper sterility checks.
Check for product number SERB65-09-60-80, lot number B644679, or UDI-DI 00643169728974 on the packaging. This stent was sold between 2021 and 2023 in the U.S.
Look for product number SERB65-09-60-80, lot number B644679, or UDI-DI 00643169728974 on the packaging.
The recall is for packaging seal defects that could compromise sterility, not for the stent itself being unsafe when used correctly.
Check for product number SERB65-09-60-80, lot number B644679, or UDI-DI 00643169728974 on the packaging.
The recall does not require stopping use; it focuses on packaging sterility risks that can be managed with proper handling.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0623-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0623-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
