EverFlex™ EVD35-08-080-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684051290), received between Apr 28, 2023 and Sep 20, 2024 — classified as 3 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2024Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  PHYSICIAN ATTEMPTED TO USE AN EVERFLEX ENTRUST SELF-EXPANDING STENT WITH A 7FR 23CM NON-MEDTRONIC SHEATH AND A 180CM .035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 60MM PLAQUE LESION IN THE PATIENT¿S LEFT DISTAL COMMON ILIAC ARTERY. MINIMAL VESSEL TORTUOSITY WAS REPORTED. 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 NOT PRE-DILATED. THE VESSEL WAS POST-DILATED. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED VISIPRO 8X17 STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. PATIENT HAD PRIOR KISSING ILIAC STENTS BUT A REASONABLY GOOD BIFURCATION. ACCESS WAS MADE UP-AND-OVER FROM RIGHT GRO IN TO LEFT SIDE AND A STENT WAS NEEDED DISTAL TO THE EXISTING LEFT COMMON ILIAC STENT DOWN INTO THE LEFT EXTERNAL ILIAC. AN 8X80 EVERFLEX ENTRUST WAS SELECTED. THE ENTRUST WAS LOADED ON THE WIRE AND ADVANCED TO THE TARGET LOCATION. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SEC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20264847 ↗
• InjuryMay 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE EVERFLEX ENTRUST STENT WAS IMPLANTED IN THE LEFT EXTERNAL ILIAC (L1). DURING THE PROCEDURE A LEFT EXTERNAL ILIAC PERFORATION OCCURRED. IT WAS STATED THAT THE PERFORATION WAS NOT DUE TO A MEDTRONIC DEVICE. THE LEFT EXTERNAL ILIAC PERFORATION OCCURRED FOLLOWING POST BALLOON DILATION WITH A NON MDT DEVICE AFTER THE STENT WAS DEPLOYED. THE BALLOON WAS RE-INFLATED TO TAMPONADE AREA. THE EVENT WAS TREATED WITH PROVISIONAL/BAIL OUT STENTING. A NON MDT STENT WAS DEPLOYED AND WAS SUCCESSFULLY POST DILATED WITH THE NON MDT BALLOON. THE PATIENT ALSO RECEIVED MEDICATION. NO FURTHER COMPLICATIONS OCCURRED AND THE PATIENT WAS DISCHARGED THE NEXT DAY. THE PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS PROBABLY RELATED TO THE DEVICE. AND CAUSALLY RELATED TO THE PROCEDURE. THE SPONSOR ASSESSED THE EVENT AS CAUSALLY RELATED TO THE PROCEDURE AND PROBABLY RELATED TO THE DEVICE.

  Patient problems: Perforation

  MAUDE report 16928293 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE EVERFLEX ENTRUST STENT WAS IMPLANTED IN THE LEFT EXTERNAL ILIAC (L1). APPROXIMATELY 6 DAYS POST PROCEDURE THE PATIENT SUFFERED FROM A PELVIC HEMATOMA. THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH INCREASING LEFT GROIN AND LOWER ABDOMINAL PAIN GOING DOWN THE LEFT LEG WITH SOME NUMBNESS. THE PAIN WAS SECONDARY TO A PELVIC HEMATOMA. CONTRAST EXTRAVASATION WAS OBSERVED VIA A CT SCAN AND WAS LIKELY TO BE A VENOUS LEAK. THERE WAS TRACE RETROPERITONEAL HEMORRHAGE AND ACUTE BLOOD LOSS ANEMIA NOTED. THE PATIENT WAS TREATED WITH MEDICATION AND A BLOOD TRANSFUSION. THE NEXT DAY A PERIPHERAL ANGIOGRAM SHOWED THE STENT WAS WIDELY PATENT AND NO SIGNIFICANT BLEEDING WAS OBSERVED. THE PATIENT IS RECOVERING.

  Patient problems: Extravasation; Hematoma; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 16830260 ↗

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