EverFlex PRB35-06-150-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684069264), received between Mar 29, 2018 and May 16, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K060057, P110023); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2019Activation, Positioning or Separation Problem; Physical Resistance/Sticking; Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A PROTEGE EVERFLEX STENT TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, CHRONIC TOTAL OCCLUSION(CTO) 100% STENOTIC FIBROUS LESION IN THE MID/DISTAL/PROXIMAL SUPERFICIAL FEMORAL ARTERY(SFA). THE ARTERY DIAM ETER AND LESION LENGTH WERE REPORTED TO BE 6MM/300MM, RESPECTIVELY. THE LESION WAS PRE-DILATED WITH A 6X300X130ADMIRAL XTREME BALLOON. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE BALLOON FROM THE TRAY. THE DEVICE WAS PREPPED WITHOUT ISSUE. A 7FR NON-MEDTRONIC SHEATH ALONG WITH A 0.035 NON MEDTRONIC WITH NO EMBOLIC PROTECTION WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT NO RESISTANCE WAS ENCOUNTERED NOR EXCESSIVE FORCE APPLIED WHEN ACCESSING THE LESION. ON FIRST INFLATION TO 6ATM, THE BALLOON BURST. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED FROM THE PATIENT. A NEW 6X300 ADMIRAL XTREME BALLOON WAS USED TO COMPLETE THE PRE-DILATION. THE EVERFLEX STENT WAS THEN INTRODUCED BUT IT WAS REPORTED THAT THE STENT GOT STUCK ON THE 0.035 WIRE. THE STENT AND WIRE HAD TO BE REMOVED AS A UNIT. THE STENT WAS REPORTED TO HAVE FLARED AT THE DISTAL TIP. A NEW WIRE WAS THEN USED T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8615707 ↗
• InjuryApr 6, 2018Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PHYSICIAN USED A PROTÉGÉ EVERFLEX WITH A 6FR NON-MDT SHEATH AND A NON-MEDTRONIC 0.035¿ GUIDEWIRE DURING TREATMENT OF A 150 MM CTO PLAQUE LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY(SFA). THE LESION WAS REPORTED TO HAVE EXHIBITED LITTLE TORTUOSITY AND LITTLE CALCIFICATION. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. THE STENT WAS ADVANCED TO THE INTENDED TARGET LOCATION. THE PHYSICIAN PROCEEDED TO LOOSEN SAFETY PIN ON THE STENT, THEN HE PINNED THE PROXIMAL GRIP AND BEGAN TO RETRACT THE DISTAL GRIP TOWARD THE PROXIMAL GRIP. THE STENT THEN FLOWERED AND MIDWAY THROUGH DEPLOYMENT, THE PHYSICIAN FELT RESISTANCE AND THEN A SUDDEN RELEASE AS THE TWO GRIPS MET. ON FLOURO EXAM, THE STENT WAS DIFFICULT TO SEE AS ONLY A SMALL PORTION HAD DEPLOYED. THE MARKERS ON THE DISTAL END OF STENT WERE ALSO DIFFICULT TO SEE. THERE WERE NO FURTHER ACTIONS THAT WOULD ALLOW ANY FURTHER DEPLOYMENT OF THE STENT. AN ATTEMPT WAS MADE TO REMOVE THE CATHETER BUT WHEN IT ARRIVED AT THE SHEATH OPENING IT COULD NOT BE RETRACTED FURTHER. UNDER FLUORO EXAMINATION, IT COULD BE SEEN THAT THE STENT HAD PULLED INTO THE COMMON ILIAC WITH THE CATHETER. RESISTANCE CONTINUED TO BE FELT SO T

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7402743 ↗
• MalfunctionMar 29, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE EVERFLEX STENT TO TREAT AN UNKNOWN LESION. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE PROCEDURE USED A NON-MEDTRONIC 6 FR SHEATH AND A 0.035" NON-MEDTRONIC GUIDEWIRE. THERE WAS NO DAMAGE TO THE DEPLOYMENT MECHANISMS OR DEVICE HANDLE PRIOR TO DEPLOYMENT ISSUE. THERE WAS NO RESISTANCE ADVANCING THE DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO EXCESSIVE FORCE WAS USED. NO EMBOLIC PROTECTION WAS USED. THE STENT STARTED TO DEPLOY BEFORE IT WAS REMOVED AND A NEW STENT WAS USED WITHOUT INCIDENT. THE PHYSICIAN STATED THEY NOTICED A FEW MMS OF THE DISTAL STENT MARKERS EXITING THE STENT DELIVERY CATHETER UNDER FLOROSCOPY AS IT EXITED THE SHEATH TO BE PLACED AT THE LESION. THE STENT WAS THEN REMOVED UNDEPLOYED VIA THE SHEATH STILL ATTACHED TO THE DELIVERY SYSTEM AND A NEW STENT WAS PLACED WITHOUT INCIDENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7380737 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060057, P110023. One submission often covers many models, so check the product and lot details in each record.

• Z-0623-2024 · Nov 20, 2023 · Completed
  Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
• Z-1644-2022 · Jul 14, 2022 · Open, Classified
  EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
• Z-2048-2016 · May 23, 2016 · Terminated
  EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex" Self-expanding Peripheral Stent System is a
• Z-1598-2010 · Mar 31, 2010 · Terminated
  ev3 Protg EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF: PRB35-06-150-080, REF PRB35-06-120-120 and PRB35-06-150-120), 4.5 - 5.5mm, Expiration: 2011-10-01, Rx on
• Z-0478-2010 · Nov 6, 2009 · Terminated
  Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, M