FDA Medical Device Recalls (openFDA)
Medtronic Inc.: Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
- Recall number
- Z-0623-2024
- Recalling firm
- Medtronic Inc.
- Product
- Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
- Status
- Completed
- Initiated
- 2023-11-20
- Posted
- 2024-01-02
- Terminated
- not on file
- 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 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
- 1
- Distribution
- US Nationwide distribution in the state of MN.
- Lot, serial or model codes
- Lot number B644679, UDI-DI 00643169728974.
- 510(k) numbers
- not on file
- PMA numbers
- ["P110023"]
- Product code
- NIP
- Firm FEI
- 2183870
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28