EverFlex PRB35-06-060-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684069189), received between Mar 3, 2017 and Oct 20, 2017 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionOct 20, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN USED A PROTÉGÉ EVERFLEX STENT TO TREAT A LESION IN THE SFA. IT WAS REPORTED THAT THE TIP BROKE DURING REMOVAL OF THE DEVICE. PATIENT STATUS WAS REPORTED AS ALIVE, WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6965737 ↗
• InjuryApr 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD BILATERAL ILIAC STENTS. 3 IN.PACT ADMIRAL BALLOON CATHETERS WERE USED TO TREAT THE LESION IN THE POPLITEAL TO POPLITEAL/TIBIAL TRUNK. PROTEGE STENT WAS IMPLANTED IN THE ILIAC ARTERY TO COMPLETE THE PROCEDURE. PHYSICIAN FLIPPED PATIENT OVER AND ACCESSED THE POPLITEAL ARTERY TO DELIVER THE DCB INTO THE SFA. PATIENT HAD JUST RECENTLY HAD SHINGLES. DR. (B)(6) WAS THE PHYSICIAN THAT DID THE PROCEDURE BUT SALES REP WAS CONTACTED BY DR. (B)(6) THE FOLLOWING WEEK. PATIENT HAD SHINGLES PRIOR TO THIS BUT PHYSICIAN SAID THE RASH WAS DIFFERENT THAN THE SHINGLES. THE SFA MID TO DISTAL WAS TREATED THROUGH POPLITEAL ACCESS HOWEVER NO RASH OCCURRED ON THIS PORTION OF LEG IT WAS ALL DISTAL TO AREA TREATED. PATIENT WAS TREATED WITH STEROIDS. STEROID WAS DELIVERED ORALLY STEROID DOSE PACK

  Patient problems: Reaction

  MAUDE report 6489254 ↗
• MalfunctionMar 3, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO IMPLANT A PROTÉGÉ EVERFLEX STENT IN A LESION IN THE SFA. THE DEVICE WAS PREPPED WITH NO ISSUES IDENTIFIED. THE STENT WAS LOADED ON THE 0.035 GUIDEWIRE. IT WAS REPORTED THAT WHEN PHYSICIAN WAS ADVANCING THE STENT CATHETER, HE ENCOUNTERED ¿SLIGHT¿ RESISTANCE AS THE CATHETER MOVED FORWARD. AS THE CATHETER TIP APPROACHED THE HUB OF SHEATH, THE STENT WAS NOTICED TO BE PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. NO INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6376556 ↗

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