Protégé EverFlexRecalls & reported problems across all models

We found 5 models of Protégé EverFlex by Ev3, Inc in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Jan 4, 2017 and Mar 11, 2026 — classified as 11 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 reports).

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

Most reported Protégé EverFlex problems

Protégé EverFlex models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Protégé EverFlex™ PRB35-05-120-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  11 reports
• Protégé EverFlex™ PRB35-05-080-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  4 reports
• Protégé EverFlex™ PRB35-05-040-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• Protégé EverFlex™ PRB35-05-100-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• Protégé EverFlex™ PRB35-05-060-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report

Recent Protégé EverFlex adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Material Deformation

  LIMITED INFORMATION REPORTED THAT STENT DEFORMATION WAS OBSERVED WITH THE PRB35-05-040-120 PROTEGE EF STENT. THE STENT REMAINS IMPLANTED IN THE PATIENT. THE DELIVERY SYSTEM WAS SAFELY REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567555 ↗
• MalfunctionJan 27, 2026Premature Activation; Difficult to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE PRB35-05-120-120 PROTEGE EF STENT, MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. AS THE STENT WAS BEING ADVANCED IN THE PATIENT, IT PREMATURELY STARTED TO FLOWER, WHICH PREVENTED ADVANCEMENT TO THE TARGET LESION IN THE SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND REPLACED WITH A DIFFERENT STENT TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24186818 ↗
• InjuryMay 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING TWO PROTEGE EF STENTS, THERE WERE SEVERAL HOURS OF DELAYS DUE TO PRODUCT MALFUNCTION. THE DEVICES WERE INTENDED TO TREAT A LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. THERE WAS NO RESISTANCE WHEN ADVANCING EITHER DEVICE. AFTER IMPLANTING THE FIRST PROTEGE EF THE TIP OF THE DELIVERY CATHETER BROKE OFF, NECESSITATING A CUT DOWN PROCEDURE TO REMOVE THE BROKEN CATHETER. THE SECOND PROTEGE EF STENT WAS DEPLOYED PROPERLY, THE END OF THE STENT CATHETER TIP BROKE OFF POST-DEPLOYMENT, REQUIRING REMOVAL FROM THE BLOOD VESSEL VIA SHEATH CAPTURE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 21992044 ↗
• InjurySep 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN ATTEMPTED TO IMPLANT A PROTEGE EVERFLEX STENT WITH A 035 GUIDEWIRE FOR THE TREATMENT OF A SOFT TISSUE LESION IN THE PATIENTS LEFT MID ARTERIOVENOUS FISTULA. SEVERE TORTUOSITY WAS REPORTED. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT POST-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE MARKERBAND DISLODGED DURING USE IN THE PATIENT. THE STENT WAS DEPLOYED IN THE TARGET LOCATION AND REMAINS IN THE PATIENT. THERE WAS NO DEFORMATION NOTED TO THE DEPLOYED STENT. THE PATIENT WAS TAKEN TO SURGERY FOR REMOVAL OF FOREIGN BODY. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS ABORTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278597 ↗
• InjuryApr 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A PROTÉGÉ EVERFLEX SELF-EXPANDING STENT AND AN INPACT ADMIRAL DCB BALLOON DURING TREATMENT OF A SOFT TISSUE LESION IN THE PATIENT¿S RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). 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. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE AND POST DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE DISTAL OUTER SHEATHING / TIP OF STENT BROKE OFF IN THE VESSEL DURING PROCEDURE AND HAD TO BE SURGICALLY REMOVED. THE STENT WAS SUCCESSFULLY DEPLOYED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE INPACT ADMIRAL. INFLATION DIFFICULTIES WERE REPORTED. NO LEAKS WERE NOTED ON THE DEVICE. THE INPACT ADMIRAL WAS SAFELY REMOVED FROM THE PATIENT. PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077490 ↗
• MalfunctionJun 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PROTEGE EVERFLEX STENT WAS DEPLOYED OVER A 0.35 WIRE WITHOUT DIFFICULTY. THE PHYSICIAN REMOVED THE STENT CATHETER FROM THE BODY AND NOTICED THE END OF THE CATHETER WAS MISSING, PHYSICIAN THEN REMOVED THE WIRE AND FOUND THE TIP AND THE END OF STENT CATHETER ATTACHED TO THE WIRE. NO PATIENT INJURY REPORTED FOR THIS EVENT

  Patient problems: Insufficient Information

  MAUDE report 14753990 ↗
• MalfunctionMay 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE EVERFLEX SELF-EXPANDING STENT ALONG WITH NON-MEDTRONIC 6FR SHEATH AND 0.035" GUIDEWIRE DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 80% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 5MM AND 100MM RESPECTIVELY. NO EMBOLIC PROTECTION WAS USED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE DEVICE DETACHED WHEN BEING REMOVED FROM THE BODY OVER THE WIRE. CATHETER BREAK/FRACTURE OCCURRED. THE DETACHED PORTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT, THE DETACHED PORTION WAS STUCK ON THE WIRE. THE LESION WAS PREDILATED WITH AN INPACT ADMIRAL 4 X 120 DCB. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE WAS COMPLETED WITH THE WIRE REMOVED WITH THE BROKEN PIECE OF CATHETER ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14307047 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY PATIENT REPRESENTATIVE THAT A PATIENT HAS HAD A RASH EVER SINCE HAVING 2 VISI-PRO BALLOON EXPANDABLE STENTS AND 2 PROTÉGÉ EVERFLEX STENTS IMPLANTED TO TREAT THE LEFT ILIAC AND LEFT SFA AND POPITEAL VESSELS. SYMPTOMS STARTED 1 DAY POST PROCEDURE. THE PHYSICIAN DOESN¿T THINK THERE WAS ANY ISSUES DURING STENT IMPLANTATION. PHYSICIAN DID NOT DETERMINE THE STENTS LED TO PATIENT SYMPTOMS. PATIENT CURRENTLY BEING TREATED WITH CREAM PROVIDED BY DERMATOLOGIST. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Rash

  MAUDE report 14209756 ↗
• InjuryFeb 7, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A PROTÉGÉ EVERFLEX SELF-EXPANDING STENT ALONG WITH NON-MEDTRONIC 6FR SHEATH AND GUIDEWIRE DURING PROCEDURE TO TREAT A NONE CALCIFIED LESION IN THE PROXIMAL POSTERIOR TIBIAL ARTERY (PTA) AND PERONEAL ARTERY (PA). THE VESSEL WAS NONE TORTUOUS THE VESSEL DIAMETER AND LESION LENGTH ARE 2MM - 3MM AND 2MM RESPECTIVELY. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. POST STENTING, THE TIP AND DISTAL CATHETER MARKER CAME APART. THE BREAK/FRACTURE OCCURRED AT THE CATHETER. PHYSICIAN TREATED THE POPLITEAL ARTERY (POP), RETRIEVED PIECE FROM THE PERONEAL BIFURCATION OF THE PATIENT. THE DETACHED PORTION OF DEVICE REMAINS IN PATIENT. THE MARKER BEING RADIOPAQUE WAS RETRIEVED, THE PLASTIC NOSECONE (TIP) OF THE STENT CATHETER WAS NOT OBSERVED. THE PATIENT WOULD BE BROUGHT FOR ITS REMOVAL. THE LESION WAS NOT PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT PROCEDURE WAS DONE IN SAFE MANNER, POPLITEAL ARTERY TR

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 13471263 ↗
• MalfunctionSep 22, 2021Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  PHYSICIAN WAS ATTEMPTING TO USE AN PROTÉGÉ EVERFLEX SELF-EXPANDING STENT TO TREAT A FIBROUS LESION IN A FISTULA. A 6FR NON-MEDTRONIC SHEATH WAS USED. A .035 GUIDEWIRE WAS USED. DEVICE WAS PREPPED PER IFU. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. STENT WAS IN THE SHEATH. THEY PULLED THE SHEATH OUT OF THE BODY. DISLODGED STENT WAS REMOVED FROM PATIENT. A SECOND PROTÉGÉ EVERFLEX STENT WAS OPENED. A 6FR NON-MEDTRONIC SHEATH WAS USED. A .035 GUIDEWIRE WAS USED. IFU WAS FOLLOWED. STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. STENT WAS SURGICALLY REMOVED. PATIENT WAS IN THE OR AND SURGEON DID A REVISION ON THE FISTULA. NO FURTHER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512662 ↗
• InjurySep 22, 2021Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE AN PROTÉGÉ EVERFLEX SELF-EXPANDING STENT TO TREAT A FIBROUS LESION IN A FISTULA. A 6FR NON-MEDTRONIC SHEATH WAS USED. A .035 GUIDEWIRE WAS USED. DEVICE WAS PREPPED PER IFU. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. STENT WAS IN THE SHEATH. THEY PULLED THE SHEATH OUT OF THE BODY. DISLODGED STENT WAS REMOVED FROM PATIENT. A SECOND PROTÉGÉ EVERFLEX STENT WAS OPENED. A 6FR NON-MEDTRONIC SHEATH WAS USED. A .035 GUIDEWIRE WAS USED. IFU WAS FOLLOWED. STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. STENT WAS SURGICALLY REMOVED. PATIENT WAS IN THE OR AND SURGEON DID A REVISION ON THE FISTULA. NO FURTHER INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12512658 ↗
• InjuryJul 2, 2020Entrapment of Device; Fracture; Detachment of Device or Device Component; Entrapment of Device; Fracture; Detachment of Device or Device Component

  THE PHYSICIAN ATTEMPTED TO USE A PROTÉGÉ EVERFLEX STENT TO TREAT A SOFT TISSUE PLAQUE WITH LITTLE CALCIFICATION AND UNKNOWN % LESION STENOSIS IN THE LEFT MID TIBIAL/POPLITEAL TRUNK. THE ARTERY DIAMETER WAS 5MM AND LESION LENGTH WAS 40 MM. THE STENT WAS APPLIED TO TRAP CLOT, CHRONIC TOTAL OCCLUSION WAS LOCATED IN THE SFA. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. A 6F 45CM NON-MEDTRONIC SHEATH FRENCH AND WHOLEY WIRE WERE USED. NO EMBOLIC PROTECTION WAS USED. 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 DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS NOT PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. IT IS REPORTED THAT A BREAK/FRACTURE OCCURRED AT THE CATHETER TIP. THE STENT CATHETER WAS PULLED OUT OF THE PATIENT AFTER DEPLOYMENT AND THE TIP WAS NOTICED ON FLUOROSCOPY. THE COMPONENT EMB OLIZED IN THE VESSEL. THE DETACHED PORTION OF DEVICE DID NOT REMAIN IN THE PATIENT AND WAS REMOVED WITH A SNARE, THE PATIENT WAS NOT HARMED. THERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10223549 ↗
• InjuryNov 20, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN IMPLANTED A PROTEGE EVERFLEX STENT IN LITTLE CALCIFIED AND MODERATELY TORTUOUS MID POPLITEAL VESSEL WITH 80% STENOSIS. THE DEVICE WAS USED ALONG WITH 6MM SPIDER FX. THE DEVICE WAS PREPPED PER THE IFU. IT WAS REPORTED THAT DURING REMOVAL OF DELIVERY SYSTEM AFTER STENT DEPLOYMENT, THE TIP DETACHED IN THE SHEATH AND WAS CAPTURED USING A SNARE. STENT WAS DEPLOYED CORRECTLY BUT THE TIP OF CATHETER CAME OFF AFTER DEPLOYMENT. IT WAS PULLED BACK INTO THE SHEATH AND WAS ABLE TO SNARE IT WITH NO ISSUES. THE LESION WAS NOT PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE.

  Patient problems: Injury

  MAUDE report 9346570 ↗
• MalfunctionMar 27, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A PROTEGE EVERFLEX STENT TO TREAT A SEVERELY CALCIFIED, MODERATELY TORTUOUS, 100%(CHRONIC TOTAL OCCLUSION, CTO) STENOTIC LESION IN THE DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY(SFA). THE ARTERY DIAMETER AND LESION LENGTH WERE 5MM 300MM, RESPECTIVELY. THE LESION WAS PRE-DILATED WITH A 3MM DEVICE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY. THE DEVICE WAS PREPPED WITHOUT ISSUE. A 6FR NON-MEDTRONIC SHEATH AND A A 0.035X300CM NON-MEDTRONIC GUIDEWIRE WERE USED FOR THE PROCEDURE. NO EMBOLIC PROTECTION WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE WAS ENCOUNTERED AND NO EXCESSIVE FORCE WAS APPLIED DURING DELIVERY OF THE DEVICE TO THE LESION. THE ACTUAL PROCEDURE WAS CARRIED OUT WITHOUT INCIDENT. AFTER DEPLOYMENT OF THE STENT AND POST THE PROCEDURE, IT WAS NOTED THAT THE DEVICE ITSELF WAS EXPIRED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8455755 ↗
• InjuryMar 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN USED A PROTÉGÉ EVERFLEX DURING TREATMENT OF A CALCIFIED/PLAQUE LESION IN THE PATIENT¿S SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY) EMBOLIC PROTECTION WAS NOT USED. THE DEVICE WAS PREPPED WITHOUT ISSUE. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO EXCESSIVE FORCE WAS USED. IT IS REPORTED THE DELIVERY SYSTEM BECAME STUCK AND A PIECE OF THE PROXIMAL STENT BROKE OFF DURING ATTEMPTED REMOVAL RESULTING IN THE DETACHED PORTION EMBOLISING AT THE TARGET LESION. ANOTHER EVERLFEX ENTRUST WAS PLACED OVER THE DETACHED PORTION. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8420981 ↗

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