CLASS II Device recall · Reported 10 Jan 2024 · FDA Enforcement Report
Protege GPS Self-Expanding Peripheral Stent System recalled by Medtronic
Medtronic is recalling Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, distributed nationwide in the US. The recall was initiated on 20 Nov 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0623-2024
- FDA event ID
- 93558
- Recalling firm
- Medtronic, Plymouth, MN
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 20 Nov 2023
- FDA classified
- 2 Jan 2024
- Reported
- 10 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 20 Nov 2023 | Recall initiated by company | |
| 2 Jan 2024 | Classified by FDA | +43 days |
| 10 Jan 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Seal defects could compromise the ability of the product packaging to maintain sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Where it was distributed
US Nationwide distribution in the state of MN.
Questions about this recall
Why was it recalled?
Seal defects could compromise the ability of the product packaging to maintain sterility.
Which lots are affected?
Lot number B644679, UDI-DI 00643169728974.
Where was it sold?
US Nationwide distribution in the state of MN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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