Protégé™ GPS™ SERB65-14-60-120Recalls & reported problems
Ev3, Inc · STENT SERB65-14-60-120 PROTEGE GPS V05 · Class 2 · Implant
All models of Protégé GPS (26)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684071755), received between May 11, 2021 and May 11, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2021Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A PROTÉGÉ GPS SELF-EXPANDING STENT DEVICE TO TREAT A LVAD OUTFLOW LESION IN A PATIENT. THERE WAS NO DAMAGE NOTED TO PACKAGING, THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. DEVICE WAS PREPPED AS PRE IFU. IT WAS REPORTED THAT THE STENT WAS USED POT ITS EXPIRY DATE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, RESISTANCE WAS NOT EXPERIENCED, NO EXCESSIVE FORCE WAS USED. A TOTAL OF THREE WERE STENTS WERE DEPLOYED AND POST DILATED WITH A NON MEDTRONIC BALLOON. WHILE PRESENT FOR CASE, PRODUCT WAS DEPLOYED AND AFTER IMPLANTED, IT WAS DETERMINED TO BE PAST ITS USED BY DATE. NO PATIENT INJURY OCCURRED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11804293 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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