EverFlex PRB35-07-150-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684069431), received between Jul 4, 2017 and Jul 4, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Inaccurate Delivery” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 4, 2017Inaccurate Delivery; Inaccurate Delivery

  PHYSICIAN INTENDED TO USE A PROTÉGÉ EVERFLEX DEVICE FOR TREATMENT OF A MODERATELY CALCIFIED, NON-TORTUOUS SOFT TISSUE LESION IN PROXIMAL LOCATION IN THE COMMON ILIAC ARTERY. IFU WAS FOLLOWED. THE DEVICE WAS PREPPED WITHOUT ISSUE. THERE WAS NO RESISTANCE ENCOUNTERED AND NO EXCESSIVE FORCE WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE STENT WAS DEPLOYED IN UNINTENDED LESION SITE (PAST TARGET LESION). DUE TO THIS ADDITIONAL STENTS HAD TO BE IMPLANTED. NO FURTHER CLINICAL SEQUELAE REPORTED FOR THIS EVENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6685337 ↗

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