EverFlex™ EVD35-07-100-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684051450), received between Oct 16, 2023 and May 14, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT WITH A 4/5 NON-MEDTRONIC SHEATH AND A 014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 90MM PLAQUE LESION IN THE PATIENT¿S RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA). MINIMAL VESSEL TORTUOSITY AND MINIMAL VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 80% STENOSIS. ARTERY DIAMETER REPORTED AS 6MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE DILATED WITH A 6X120 INPACT BALLOON. THE VESSEL WAS POST DILATED WITH A 6X40 NANOCROSS BALLOON. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THE TIP BROKE OFF IN PATIENT. AFTER STENT DEPLOYMENT A SECOND STENT WAS USED TO PIN TIP DOWN. THE DELIVERY SYSTEM WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309762 ↗
• MalfunctionOct 16, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A EVERFLEX ENTRUST TO TREAT SOFT TISSUE LESION IN THE LEFT MID EXTERNAL ILIAC.  DEGREE OF TORTUOSITY WAS NONE. DEGREE OF CALCIFICATION WAS NONE.  LESION STENOSIS WAS 80%. A 6X45 DESTINATION SHEATHE FRENCH WAS USED. A 014 GUIDEWIRE WAS USED. A NAV6 WAS USED FOR EMBOLIC PROTECTION. DEVICE WAS PREPPED PER IFU. LESION WAS PRE-DILATED WITH A 7X60 PRE-DILATION DEVICE.  NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE.  NO EXCESSIVE FORCE WAS USED. DEPLOYMENT ISSUES OCCURRED. THERE WAS PARTIAL DEPLOYMENT.  THERE WAS NO DAMAGE TO THE DEPLOYMENT MECHANISMS OR DEVICE HANDLE PRIOR TO DEPLOYMENT ISSUE. LOCK PIN WAS REMOVED WHEN DEVICE WAS READY TO DEPLOY. THE STRING WAS CAUGHT UP IN THE THUMBWHEEL. PROCEDURE COMPLETED BY DEPLOYING STENT, POST DILATED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17938544 ↗

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