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Protégé GPS recallZ-0623-2024 · Medtronic Inc. · initiated Nov 20, 2023

Completed

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Packaging change control

What the company is doing

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.

Recall details

Recall number
Z-0623-2024
Status
Completed
Initiated by the company
Nov 20, 2023
Posted by the FDA
Jan 2, 2024
Recalling firm
Medtronic Inc.
Quantity
1
Product code
NIP
FDA submissions
P110023
Distribution
US Nationwide distribution in the state of MN.

Product description

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

Code information (models, lots, serial numbers)

Lot number B644679, UDI-DI 00643169728974.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

82 devices cleared under P110023 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page