Recall Z-0623-2024— Medtronic Inc.
Class II · Completed
Class II FDA medical device recall by Medtronic Inc., initiated 2023-11-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.. Reason: Seal defects could compromise the ability of the product packaging to maintain sterility..
- Recalling firm
- Medtronic Inc.
- Classification
- Class II
- Status
- Completed
- Initiated
- 2023-11-20
- Firm location
- Plymouth, MN, United States
Product description
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Reason for recall
Seal defects could compromise the ability of the product packaging to maintain sterility.
Data sourced from openFDA. This site is unofficial and independent of the FDA.