Protégé GPSRecalls & reported problems across all models
Ev3, Inc · 26 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 39
- Deaths reported
- 2
- Injuries reported
- 13
- Recalls
- 1
We found 26 models of Protégé GPS by Ev3, Inc in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Dec 21, 2016 and Apr 3, 2026 — classified as 2 deaths, 13 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (10 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Protégé GPS recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 20, 2023Completed
Seal defects could compromise the ability of the product packaging to maintain sterility.
Z-0623-2024 · Root cause: Packaging change control · Recall details · FDA record ↗
Most reported Protégé GPS problems
Device problems
- Material Deformation10
- Use of Device Problem9
- Detachment of Device or Device Component7
- Activation, Positioning or Separation Problem4
- Fracture4
- Premature Activation4
- Difficult to Remove3
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Consequences Or Impact To Patient12
- Patient Problem/Medical Problem6
- Insufficient Information2
- Chest Pain1
- Death1
- Local Reaction1
- No Information1
Protégé GPS models
26 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Protégé™ GPS™ SERB65-09-60-80STENT, ILIAC1 recall0 reports
- Protégé™ GPS™ SERB65-12-60-80STENT, ILIAC4 reports
- Protégé™ GPS™ SERB65-10-40-120CATHETER, BILIARY, DIAGNOSTIC3 reports
- Protégé™ GPS™ SERB65-10-80-120STENT, ILIAC1 death3 reports
- Protégé™ GPS™ SERB65-14-60-80CATHETER, BILIARY, DIAGNOSTIC3 reports
- Protégé™ GPS™ SERB65-14-80-80CATHETER, BILIARY, DIAGNOSTIC3 reports
- Protégé™ GPS™ SERB65-10-40-80CATHETER, BILIARY, DIAGNOSTIC2 reports
- Protégé™ GPS™ SERB65-10-80-120STENT, ILIAC2 reports
- Protégé™ GPS™ SERB65-10-80-80CATHETER, BILIARY, DIAGNOSTIC2 reports
- Protégé™ GPS™ SERB65-09-20-120STENT, ILIAC1 report
- Protégé™ GPS™ SERB65-09-40-120CATHETER, BILIARY, DIAGNOSTIC1 death1 report
- Protégé™ GPS™ SERB65-09-60-120CATHETER, BILIARY, DIAGNOSTIC1 report
- Protégé™ GPS™ SERB65-09-80-80STENT, ILIAC1 report
- Protégé™ GPS™ SERB65-10-20-80STENT, ILIAC1 report
- Protégé™ GPS™ SERB65-12-60-120CATHETER, BILIARY, DIAGNOSTIC1 report
- Protégé™ GPS™ SERB65-09-20-120CATHETER, BILIARY, DIAGNOSTIC1 report
- Protégé™ GPS™ SERB65-09-30-120CATHETER, BILIARY, DIAGNOSTIC1 report
- Protégé™ GPS™ SERB65-09-40-80STENT, ILIAC1 report
- Protégé™ GPS™ SERB65-10-30-80CATHETER, BILIARY, DIAGNOSTIC1 report
- Protégé™ GPS™ SERB65-10-40-80CATHETER, BILIARY, DIAGNOSTIC1 report
- Protégé™ GPS™ SERB65-10-60-120STENT, ILIAC1 report
- Protégé™ GPS™ SERB65-10-80-80STENT, ILIAC1 report
- Protégé™ GPS™ SERB65-12-80-80CATHETER, BILIARY, DIAGNOSTIC1 report
- Protégé™ GPS™ SERB65-14-20-80CATHETER, BILIARY, DIAGNOSTIC1 report
- Protégé™ GPS™ SERB65-14-40-80CATHETER, BILIARY, DIAGNOSTIC1 report
- Protégé™ GPS™ SERB65-14-60-120CATHETER, BILIARY, DIAGNOSTIC1 report
Recent Protégé GPS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 3, 2026Difficult to Remove
IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE USING THE PROTEGE GPS STENT SYSTEM IN THE EXTERNAL ILIAC ARTERY, THERE WAS A 10-MINUTE DELAY IN SURGERY DUE TO PRODUCT ISSUES. REMOVAL DIFFICULTIES WERE REPORTED WHEN THE STENT SYSTEM TIP RETRACTED INTO THE SHEATH, AND THE STENT SYSTEM REQUIRED SNARING FOR REMOVAL. THE LESION LENGTH WAS REPORTED AS 70 MM AND THE ARTERY/VEIN DIAMETER AS 9 MM. THE VESSEL WAS POST-DILATED. THE STENT SYSTEM WAS REPORTED TO HAVE BEEN SAFELY REMOVED, AND NO VESSEL DAMAGE WAS REPORTED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24776068 ↗MalfunctionApr 3, 2026Use of Device Problem
IT WAS REPORTED THAT DURING A PERIPHERAL ARTERY PROCEDURE A PROTEGE GPS STENT WAS IMPLANTED IN THE LEFT COMMON ILIAC ARTERY (PROXIMAL AND MID SEGMENTS) FOR A TARGET LESION DESCRIBED AS 30MM PLAQUE LESION WITH MINIMAL TORTUOSITY, MINIMAL CALCIFICATION, AND A VESSEL DIAMETER OF 9 MM. THE STENT WAS PLACED BEFORE THE EXPIRATION DATE WAS CHECKED, AND IT WAS THEN IDENTIFIED THAT THE DEVICE WAS EXPIRED. THE VESSEL WAS PRE-DILATED AND POST-DILATED, NO EMBOLIC PROTECTION WAS USED, NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND NO PACKAGING OR DEVICE REMOVAL ISSUES WERE REPORTED. THE DEVICE WAS USED IN THE PATIENT AND REMAINED IMPLANTED, AND THE PROCEDURE WAS REPORTED TO HAVE PROCEEDED AS NORMAL. NO INJURY, INTERVENTION, OR HEALTH CONSEQUENCES WERE REPORTED, AND THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24774696 ↗MalfunctionJan 9, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING USE OF THE STENT SERB65-10-80-80 PROTEGE GPS IN THE SUBCLAVIAN, CATHETER HANDLE SEPARATION OCCURRED (COMPLETELY DETACHED). THE LESION LENGTH WAS 60MM, AND A 6 FRENCH SHEATH AND NON MEDTRONIC GUIDEWIRE WERE USED. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE, AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE HANDLE WAS CRACKED TO AID IN DEPLOYMENT AND THE STENT WAS DEPLOYED IN THE TARGET LOCATION. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24017980 ↗MalfunctionMar 4, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT AN EXPIRED STENT, SPECIFICALLY A PROTEGE GPS STENT, WAS IMPLANTED IN A PATIENT. THE PROCEDURE WAS COMPLETED AND THE DEVICE REMAINS IN SERVICE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21512881 ↗DeathJan 23, 2025Fracture; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Fracture; Activation, Positioning or Separation Problem; Detachment of Device or Device Component
IT WAS REPORTED WHILE ATTEMPTING TO DEPLOY THE PROTEGE GPS STENT, THE CATHETER BECAME LODGED WITH THE STENT PARTIALLY DEPLOYED. WHILE TRYING TO COMPLETELY DEPLOY AND DETACH FROM THE STENT, THE CATHETER FRACTURED LEAVING THE DISTAL END OF THE CATHETER LODGED IN THE PATIENT. ATTEMPTS TO REMOVE THE RETAINED PORTION OF THE CATHETER FROM THE PATIENT WERE NOT SUCCESSFUL.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury
MAUDE report 21218136 ↗MalfunctionSep 27, 2024Premature Activation; Premature Activation
PHYSICIAN ATTEMPTED TO USE A PROTEGE GPS SELF-EXPANDING STENT WITH A 45 CM 6 FR NON-MEDTRONIC SHEATH DURING TREATMENT OF A 30 MM CALCIFIED LESION IN THE PATIENTS RIGHT DISTAL COMMON ILIAC ARTERY. SEVERE VESSEL CALCIFICATION WAS REPORTED. LESION EXHIBITED 70% STENOSIS. ARTERY DIAMETER REPORTED AS 10 MM. THERE WERE ABNORMALITIES REPORTED IN RELATION TO ANATOMY. NARROWING WAS AT THE DISTAL END OF A VERY SHORT COMMON ILIAC WITH CALCIFICATION AND SEVERE NARROWING OF THE RIGHT INTERNAL ILIAC ARTERY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE-DILATED. THE VESSEL WAS NOT POST-DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THE STENT DEPLOYED PREMATURELY INSIDE OF THE ACCESS SHEATH AS THE SYSTEM WAS BEING ADVANCED TO THE LESION SITE AND REMAINED INSIDE THE SHEATH. THE STENT DOES NOT REMAIN IN THE PATIENT. THE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20320197 ↗InjuryAug 15, 2024Fracture; Material Deformation; Fracture; Material Deformation
ON (B)(6) 2024 PHYSICIAN IMPLANTED A PROTEGE GPS SELF-EXPANDING STENT DURING TREATMENT OF AN 80MM LESION IN THE PATIENTS LEFT PROXIMAL CEPHALIC SUBCLAVIAN VEIN. MODERATE VESSEL TORTUOSITY AND MINIMAL VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 70% PLUS STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, (I.E. SHELF CARTON, HOOP/TRAY). NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. ON (B)(6) 2024 DURING DEVICE FOLLOW UP A FRACTURE WAS NOTED TO THE DEPLOYED STENT. A REPLACEMENT 10X80X80 MEDTRONIC STENT WAS PLACED OVER THE PROTÉGÉ STENT. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19989438 ↗InjuryJul 10, 2023Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT CONTACTED MEDTRONIC TO FIND OUT WHAT METALS ARE IN THE PROTÉGÉ GPS STENT. PATIENT EXPRESSED THAT SHE HAD A PROTÉGÉ GPS STENT IMPLANTED BUT SHE DID NOT TELL THE IMPLANTING PHYSICIAN THAT SHE IS ALLERGIC TO NICKEL. THE PATIENT EXPRESSED THAT SHE HAS A RASH ALL OVER HER BODY.
Patient problems: Local Reaction; Rash
MAUDE report 17286463 ↗MalfunctionMay 15, 2023Difficult to Remove; Detachment of Device or Device Component; Device Dislodged or Dislocated; Difficult to Remove; Detachment of Device or Device Component; Device Dislodged or Dislocated
A PHYSICIAN WAS ATTEMPTING TO USE A PROTÉGÉ GPS SELF-EXPANDING STENT WITH A 6FR SHEATH AND A 0.035 GUIDEWIRE DURING TREATMENT OF THE PATIENTS SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS NO DAMAGE NOTED TO PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE USED. IT IS REPORTED STENT DISLODGEMENT OCCURRED DURING SHEATH REMOVAL AND THAT A DEVICE COMPONENT DETACHED/CRACKED/FRACTURED DURING DELIVERY THROUGH THE VESSEL. THERE WAS ALSO DIFFICULTY REMOVING DEVICE PRIOR TO STENT DEPLOYMENT ALSO REPORTED. THE THE WHOLE SYSTEM WAS REMOVED. THE DETACHED PORTION OF DEVICE DOES NOT REMAIN IN PATIENT. AS THE STENT WAS DAMAGED, THE PROCEDURE WAS NOT CONTINUED WHICH LEAD TO EXTENDED PATIENT HOSPITALIZATION. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16929149 ↗MalfunctionJan 31, 2023Premature Activation; Premature Activation
A PROTÉGÉ GPS WAS INTENDED TO BE IMPLANTED FOR THE TREATMENT OF AN UNKNOWN LESION IN THE MID LEFT REGION OF THE COMMON ILIAC ARTERY. A 7FR SHEATH AND NON MDT GUIDEWIRE WERE USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED WITH A 9MM X 30 PRE-DILATION DEVICES. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT. THE LOCK PIN WAS NOT REMOVED JUST LOOSENED PRIOR TO DEPLOYMENT. THE DEVICE HAD NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND THEN FROZE ON THE WIRE. STENT DEPLOYED ON WIRE PRIOR TO INSERT IN PATIENT. THE WHOLE SYSTEM PARTIALLY DEPLOYED, AND THE WIRE WAS REMOVED FROM THE PATIENT THROUGH THE SHEATH AND THE CASE WAS FINISHED WITH A BALLOON ANGIOPLASTY. NO VESSEL DAMAGE REPORTED, AND NO PATIENT INJURY REPORTED FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16271335 ↗MalfunctionJul 28, 2022Use of Device Problem; Use of Device Problem
A PROTÉGÉ GPS SELF-EXPANDING PERIPHERAL STENT WAS IMPLANTED FOR TREATMENT OF A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE IFU WAS FOLLOWED AND NO ISSUES WERE NOTED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT AFTER THE STENT WAS IMPLANTED IT WAS NOTED THAT THE DEVICE WAS EXPIRED. THERE WAS NO PATIENT INJURY REPORTED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15122483 ↗MalfunctionApr 14, 2022Malposition of Device; Material Deformation; Malposition of Device; Material Deformation
PHYSICIAN WAS ATTEMPTING TO USE A PROTÉGÉ GPS SELF-EXPANDING STENT DURING PROCEDURE TO TREAT A FIBROUS LESION IN THE LEFT MID SUBCLAVIAN VEIN WITH 50% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. STENT DEFORMATION OCCURRED IN VIVO POST DEPLOYMENT. THE 80MM STENT ROLLED IN ON ITSELF AND INACCURATELY DELIVERED TO AN UNINTENDED LESION SITE. IT IS UNKNOWN IF THERE WAS ENOUGH LANDING ZONE. THE LESION WAS PRE DILATED WITH A 60MM DEVICE. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT WITH NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THERE WAS A FRACTURED STENT EXISTING IN THE PATIENT. PROTÉGÉ GPS STENT WAS DEPLOYED IN THE FRACTURED STENT. AFTER DEPLOYMENT, FLURO SHOWED THAT THE STENT HAD TRAVELLED PROXIMAL AND ROLLED IN ON ITSELF. THERE WAS NO COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO FURTHER PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14110144 ↗MalfunctionDec 13, 2021Activation Failure
PROTÉGÉ GPS SELF EXPANDING PERIPHERAL STENT SYSTEM DID NOT DEPLOY FROM SYSTEM. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Insufficient Information
MAUDE report 13002438 ↗MalfunctionOct 20, 2021Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Activation, Positioning or Separation Problem; Detachment of Device or Device Component
PHYSICIAN WAS ATTEMPTING TO USE THE PROTEGE GPS SELF EXPANDING STENT ALONG WITH A 6FR SHEATH DURING PROCEDURE TO TREAT LESION IN DISTAL RIGHT BILIARY ARTERY. THE VESSEL HAD MODERATE TORTUOSITY AND NO CALCIFICATION. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. IT WAS REPORTED THAT THERE WAS PARTIAL DEPLOYMENT. THERE WAS DAMAGE TO THE DEPLOYMENT MECHANISM/DEVICE HANDLE PRIOR TO DEPLOYMENT ISSUE. HALF OF THE STENT WAS RELEASED BUT THEN A CLICK SOUNDED, AND THE DISTAL GRIP WAS UNLEARNED AND THE STENT REMAINED IN THE MIDDLE OF THE RELEASE. THE THUMBSWITCH WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE LOCK-PIN WAS REMOVED WHEN THE WHEEL WAS RELEASED TO PROCEED WITH THE RELEASE OF THE DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DISTAL HANDLE DETACHED AFTER RELEASING HALF, THE DISTAL HANDLE CLICKED AND RELEASED AND MANAGED TO FINISH THE RELEASE BY MAKING A GENTLE COUGHING MOVEMENT, BUT IT WAS NOT NORMAL. A PREVIOUS STENT HAD BEEN USED FOR THE OTHER SIDE AND IT WAS RELEASED WITHOUT INCONVEN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12663712 ↗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 ↗
Other Ev3, Inc products
All Ev3, Inc devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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