EverFlex PRB35-07-040-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684069325), received between Oct 9, 2019 and Oct 22, 2019 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, A EVERCROSS BALLOON WAS USED TO TREAT THE LEFT VENOUS OUTFLOW. AN EVERFLEX STENT WAS ALSO IMPLANTED DURING INDEX PROCEDURE TO TREAT PERSISTENT RESIDUAL STENOSIS. APPROXIMATELY 12 MONTHS POST PROCEDURE, PATIENT SUFFERED RESTENOSIS OF THE PROXIMAL CEPHALIC VEIN OUTFLOW AND THE VENOUS OUTFLOW WAS TREATED WITH A MEDTRONIC STANDARD PTA BALLOON SAME DAY. THE PATIENT RECOVERED. THE INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO THE DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Stenosis

  MAUDE report 9217381 ↗
• InjuryOct 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, AN EVERCROSS BALLOON WAS USED TO TREAT THE LEFT VENOUS OUTFLOW. AN EVERFLEX STENT WAS ALSO IMPLANTED DURING INDEX PROCEDURE TO TREAT PERSISTENT RESIDUAL STENOSIS. APPROXIMATELY 12.5 MONTHS POST PROCEDURE THE PATIENT SUFFERED STENOSIS OF THE CEPHALIC ARCH AND WAS TREATED WITH NON-TARGET LESION REVASCULARISATION OF THE CEPHALIC ARCH USING A MEDTRONIC STANDARD PTA THE SAME DAY. THE PATIENT RECOVERED. THE INVESTIGATOR AND SPONSOR ASSESSED EVENT AS NOT RELATED TO THE DEVICE, PROCEDURE OR PACLITAXEL.

  Patient problems: Stenosis

  MAUDE report 9171275 ↗

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