EverFlex™ Protégé™ EverFlex™ PRB35-08-120-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684060308), received between Aug 10, 2022 and Aug 10, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

3 other recalls cover devices cleared under the same FDA submission (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN WAS ATTEMPTING TO DEPLOY A PROTÉGÉ EVERFLEX STENT IN A PATIENT TO TREAT A RIGHT PROX/MID/DISTAL ILIAC ARTERY ¿ COMMON ARTERY CTO LESION THAT IS REPORTED TO HAVE PLAQUE WITH MODERATE CALCIFICATION AND TORTUOSITY. THE LESION WAS PRE DILATED WITH AN EVERCROSS BALLOON, WITH NO ISSUES NOTED. THERE WAS NO DAMAGE NOTED TO PACKAGING, THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IT WAS REPORTED THAT THE DELIVERY SYSTEM OF THE DEVICE FRACTURED DURING DELIVERY THROUGH THE LESION ¿ THE CATHETER DETACHED AT THE PORTION WHERE STENT IS CRIMPED DETACHED AFTER STENT DEPLOYMENT. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT USED. AFTER DEPLOYMENT OF STENT, THE STENT APPEARED TO BE GONE BUT UPON ANGIOGRAPHY THE MARKERS OF DEPLOYMENT PORTION WERE STILL PRESENT. UPON DETAILED ANALYSIS OF ANGIOGRAM, IT WAS DETERMINED THAT THE DEPLOYMENT PORTION HAD BROKEN OFF IN PATIENT WITH WIRE STILL WITHIN IT THE DEPLOYMENT PORTION. AN ATTEMPT WAS MADE TO SNARE BROKEN PIECE, BUT THE PIECE TRAVELLED DISTALLY, SO TO PREVENT FURTHER MIGRATION, THE PHYSICIAN OPTED FOR FEMORAL CUTDOWN. NO

  Patient problems: Insufficient Information

  MAUDE report 15201409 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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