EverFlex PRB35-07-200-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684069448), received between Mar 8, 2018 and Mar 8, 2018 — classified as 1 injury.

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

• InjuryMar 8, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN EMPLOYED THE USE OF AN EVERFLEX DEVICE ALONG WITH OTHER UNKNOWN STENTS AND BALLOONS DURING TREATMENT OF A COMPLEX SFA TIBIAL LIMB SALVAGE IN AN ELDERLY PATIENT. IT WAS REPORTED THAT A FOREIGN BODY WAS OBSERVED TO BE WITHIN THE VESSEL POST IMPLANTATION OF THE EVERFLEX STENT. THE PHYSICIAN ATTEMPTED, UNSUCCESSFULLY, TO RETRIEVE THE FOREIGN BODY USING A SPIDER WIRE. AS THE FLOW WAS PATENT AND UNINHIBITED, WITH PULSES, POST-PROCEDURE, NO FURTHER INTERVENTION WAS CARRIED OUT. THE NATURE OF THE FOREIGN BODY WAS UNKNOWN. THE PATIENT IS REPORTED TO HAVE RECOVERED WELL AND TO BE DOING WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 7323009 ↗

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