Recalls / —

—#204795

Product

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

FDA product code

NIP — Stent, Superficial Femoral Artery

Device class

Class 3

Medical specialty

Unknown

PMA numbers

P110023

Affected lot / code info

Lot number B644679, UDI-DI 00643169728974.

Why it was recalled

Seal defects could compromise the ability of the product packaging to maintain sterility.

Root cause (FDA determination)

Packaging change control

Action the firm took

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.

Recalling firm

Firm

Medtronic Inc.

Address

4600 Nathan Ln N, Plymouth, Minnesota 55442-2890

Distribution

Distribution pattern

US Nationwide distribution in the state of MN.

Timeline

Recall initiated

2023-11-20

Posted by FDA

2024-01-02

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #204795. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.