Z-0623-2024Class II

Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile

Name: Z-0623-2024 Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile
Creator: Medtronic Inc.
Published: 2023-11-20
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-11-20 / Completed / root cause: packaging

FDA source

Medtronic Inc. began a recall of Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile on 2023-11-20. FDA classified it as Class II and gives the reason as "Seal defects could compromise the ability of the product packaging to maintain sterility". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0623-2024
Classification: Class II
Status: Completed
Initiated: 2023-11-20
Posted: 2024-01-02
Recalling firm: Medtronic, Inc.
Product: Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Product code: NIP Stent, Superficial Femoral Artery
Reason for recall: Seal defects could compromise the ability of the product packaging to maintain sterility.
Root cause tag: packaging
FDA 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 customer will be quarantining the device. The consignee facility was verbally notified via telephone on 11/20/2023. An Urgent Medical Device Recall letter dated November 2023 for the attention of the Risk Manager was enclosed, which was hand-delivered to the facility on 12/1/2023. The consignee is asked to identify, segregate, quarantine and return any affected product they may have in their inventory and complete and return the Customer Acknowledgement Form.
Quantity in commerce: 1
Distribution: US Nationwide distribution in the state of MN.
Product codes and lots: Lot number B644679, UDI-DI 00643169728974.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0623-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0623-2024	Class II	Completed	Voluntary: Firm initiated	2024-01-10	2024-01-02

Product code NIP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)