Protégé™ GPS™ SERB65-14-20-80Recalls & reported problems
Ev3, Inc · STENT SERB65-14-20-80 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684071700), received between Dec 3, 2018 and Dec 3, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Malposition of Device” (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
- Malposition of Device1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 3, 2018Malposition of Device; Malposition of Device
THE PHYSICIAN INTENDED TO USE THE PROTÉGÉ GPS A 6FR NON-MEDTRONIC SHEATH AND A 3J NON-MEDTRONIC GUIDEWIRE TO TREAT A LESION AT THE MID SHORT SAPHENOUS VEIN. NO TORTUOSITY WAS REPORTED. AS PER IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS NOT PRE-DILATED, NO RESISTANCE OR EXCESSIVE FORCE WAS USED. IT WAS REPORTED THE STENT JUMPED AND WAS DEPLOYED AT AN UNINTENDED LESION SITE, THE PHYSICIAN ATTEMPTED TO USE A SECOND STENT TO OVERLAP THE DEPLOYED STENT BUT WAS UNABLE AS THE FIRST STENT DISLODGED BEFORE IT COULD BE DEPLOYED. A SNARE WAS USED TO RETRIEVE THE DISLODGED STENT. ALL COMPONENTS WERE REMOVED FROM THE PATIENT. THE PATIENT DID NOT RECEIVE THE SECOND STENT
Patient problems: Patient Problem/Medical Problem
MAUDE report 8123868 ↗
Other CATHETER, BILIARY, DIAGNOSTIC devices
- Hurricane™ RX M00545900Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls1 death705 reports
- MUSTANG™ H74939171060470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC384 reports
- CRE™ PRO M00558710Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC1 recall284 reports
- Hurricane™ RX M00545920Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls211 reports
- MUSTANG™ H74939171070470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC265 reports
- MUSTANG™ H74939171050470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC212 reports
- Hurricane™ RX M00545940Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls109 reports
- MUSTANG™ H74939171100470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC203 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page