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U.S. Department of Health and Human Services

Class 2 Device Recall Protege GPS

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  Class 2 Device Recall Protege GPS see related information
Date Initiated by Firm November 20, 2023
Date Posted January 02, 2024
Recall Status1 Completed
Recall Number Z-0623-2024
Recall Event ID 93558
PMA Number P110023 
Product Classification Stent, superficial femoral artery - Product Code NIP
Product Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Code Information Lot number B644679, UDI-DI 00643169728974.
Recalling Firm/
Manufacturer		 Medtronic Inc.
4600 Nathan Ln N
Plymouth MN 55442-2890
For Additional Information Contact Erin Burns
612-827-8952
Manufacturer Reason
for Recall		 Seal defects could compromise the ability of the product packaging to maintain sterility.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = NIP and Original Applicant = MEDTRONIC VASCULAR INC
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