Recall Z-0623-2024 ยท NIP Stent, Superficial Femoral Artery
Medtronic Inc.
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
| Date | Jan 2, 2024 (initiated Nov 20, 2023) |
| Status | Completed |
| Reason | Seal defects could compromise the ability of the product packaging to maintain sterility. |
| Root cause | Packaging change control |
| Action | On 11/17/2023, Medtronic emailed an Immediate Action Communication to their field representative to guide them in speaking with their sole consignee facility. The communication provided the details of the product and the reason for recall. The field representative was to notify the consignee facility and ask them to quarantine the product. The representative was to notify the recalling firm of the name, title and phone number of the person contacted at the facility, the date and method they were notified, include any additional questions the customer has in the short-term, and advise if the |
| Quantity | 1 |
| Distribution | US Nationwide distribution in the state of MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.