EverFlex™ EVD35-06-150-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684051184), received between Oct 11, 2018 and Jun 1, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 reports).

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

• MalfunctionJun 1, 2022Activation, Positioning or Separation Problem; Physical Resistance/Sticking; Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  A PHYSICIAN WAS ATTEMPTING TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT DURING A PROCEDURE. IT WAS REPORTED THAT DURING VASCULAR CASE, THE PHYSICIAN TRIED TO DEPLOY THE STENT. IT PARTIALLY GOT DEPLOYED, THEN IT DID NOT COME OUT FULLY AS IT UNSHEATHING WAS ATTEMPTED. IT TWISTED ON THE WIRE AND GOT STUCK; HOWEVER, IT WAS REMOVED SUCCESSFULLY. AN ULTRASOUND GUIDED ACCESS OF THE LEFT COMMON FEMORAL ARTERY WAS CARRIED OUT. CATHETER WAS INTRODUCED INTO THE AORTA. THE RIGHT LOWER EXTREMITY ANGIOGRAM WITH RUN OFF WITH RADIOLOGIC SUPERVISION AND INTERPRETATION WAS DONE. SELECTIVE CATHERIZATION OF THE POSTERIOR TIBIAL ARTERY. A NON-MEDTRONIC 5.5X60MM ANGIOPLASTY OF THE RIGHT EXTERNAL ILIAC ARTERY AND COMMON FEMORAL ARTERY WAS DONE. A LASER ATHERECTOMY (6FR, 2MM, WITH 3MM X 190MM), WITH TWO NON-MEDTRONIC 6MM X 150MM AND 6MM X100MM STENTS WERE IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A NON-MEDTRONIC CLOSURE DEVICE WAS USED FOR THE LEFT COMMON FEMORAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14562605 ↗
• MalfunctionOct 11, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PHYSICIAN INTENDED TO USE THE EVERFLEX ENTRUST, WITH A NON-MEDTRONIC 6FR SHEATH AND A NON-MEDTRONIC .018 GUIDEWIRE TO TREAT A PLAQUE LESION WITH LITTLE CALCIFICATION IN THE MID SUPERFICIAL FEMORAL ARTERY. THE ARTERY DIAMETER AND LESION LENGTH WERE REPORTED TO 5.5M <(>&<)> 150MM, RESPECTIVELY. IT WAS REPORTED THAT THE PHYSICIAN HAD SUCCESSFULLY PLACED A 6X150X150 DISTAL TO THE LESION. AS HE WAS STARTED TO PLACE THIS EVERFLEX ENTRUST STENT AT THE LESION, IT DEPLOYED ABOUT 80% OF THE STENT AND THEN THE WHEEL BECAME STUCK AND WOULD NOT ROTATE. HE PRESSED HARD TO GET IT TO DEPLOY, AND THEN THE HANDLE BROKE. ONCE HE STARTED TO PULL THE CATHETER BACK, THE STENT FULLY DEPLOYED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7955360 ↗

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