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.
“Medtronic Protege GPS Stent Recall: Packaging Sterility Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56790-medtronic-protege-gps-stent-recall-packaging-sterility-risk. Based on FDA recall #Z-0623-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0623-2024%22&limit=1).
Medtronic Inc. recalled the Protege GPS Self-Expanding Peripheral Stent System due to seal defects that could compromise packaging sterility, according to the FDA on 2023-11-20.
How to tell if you have it
Brand: Medtronic
Product: Protege GPS Self-Expanding Peripheral Stent System
Product number: SERB65-09-60-80
Lot number: B644679
UDI-DI: 00643169728974
The hazard
Seal defects could compromise the ability of the product packaging to maintain sterility, according to the FDA.
Context
GovInfoNow's records show Medtronic, Inc. has 38 other recalls on record since 2017-09-10. Other recent recalls include the Medtronic Sphere-9 Catheter Recall (2026-03-11), the Medtronic Abre Venous Stent Recall (2025-12-04), and the Medtronic EVX 60 Series recall (2025-10-29). Other recent recalls of similar products include Medline Convenience Kits Recalls (2026-06-12) and a Medline IV Start Kit Recall (2026-06-12).
How to tell if you have this one
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.
Brand
Medtronic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for product number SERB65-09-60-80, lot number B644679, or UDI-DI 00643169728974 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of MN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0623-2024 (November 20, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0623-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.