EverFlex™ EVD35-08-020-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684051269), received between Oct 10, 2018 and May 19, 2021 — classified as 2 injuries.

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

• InjuryMay 19, 2021Premature Activation; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Premature Activation; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  PHYSICIAN ATTEMPTED TO USE AN EVERFLEX STENT WITH A 5FR NON-MEDTRONIC SHEATH AND NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A SOFT TISSUE LESION IN THE PATIENT¿S PROXIMAL INFERIOR VENA CAVA (IVC). THE PATIENT HAD AORTIC ATRESIA. MODERATE VESSEL TORTUOSTY IS REPORTED. EMBOLIC PROTECTION WAS NOT USED. 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. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS NOT PERFORMED. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT, BUT NO EXCESSIVE FORCE WAS USED. THE PHYSICIAN DECIDED TO PULL OUT THE DEVICE AND USE A LONGER SHEATH DUE TO THE RESISTANCE. THE LOCK-PIN WAS STILL IN PLACE GIVEN NO ATTEMPT HAD BEEN MADE TO DEPLOY THE STENT. WHEN THE DELIVERY SYSTEM WAS REMOVED THE STENT WAS OBSERVED ON FLUORO IN THE IVC. THE PHYSICIAN ATTEMPTED TO USE A SNARE TO RETRIEVE THE STENT BUT WAS UNSUCCESSFUL. THE CARDIO-THORACIC PHYSICIAN AND CA RADIOLOGIST DECIDED TO USE A BALLOON EXPANDABLE STENT WAS THEN PLACED TO SECURE THE STENT OUTSIDE THE RIGHT ATRIUM (RA) SO THAT IT CAN BE REMOVED F

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11848286 ↗
• InjuryOct 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A DISSECTED FEMORAL ARTERY DURING A ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) WHICH REQUIRED THE IMPLANTATION OF A NON-MEDTRONIC CORONARY STENT AND 2 EVERFLEX ENTRUST STENTS IN THE ILIACS. IT WAS REPORTED THERE WAS NO ALLERGY OR SYMPTOMS PRESENT DURING THE PATIENT¿S STAY AT THE FACILITY WHERE THE STENTS WERE IMPLANTED. IT WAS REPORTED THAT THE STENTS WERE IMPLANTED BY (B)(6), (B)(6) MEDICAL CENTER, IN (B)(6). HOWEVER, MONTHS POST THE REPORTED PROCEDURE, THE PATIENT WAS EXPERIENCING SOME TYPE OF ALLERGIC REACTION AND PRESENTED TO ANOTHER PHYSICIAN. A SLIGHT RASH AND SKIN DISCOLORATION WERE REPORTED. THE PATIENT HAS BEEN PROVIDED WITH ALL OF THE STENT NAMES AND METALS ASSOCIATED WITH THE EVERFLEX STENTS. THE PATIENT HAS REPORTED ATTENDING A DERMATOLOGIST AND HAS REPORTED HAVING A BIOPSY CARRIED OUT ON THE RASH. THE RESULTS OF THE BIOPSY HAVE NOT YET BEEN REPORTED. IT IS NOT KNOWN IF THE PATIENT RECEIVED ANY TREATMENT FOR THE REPORTED RASH.

  Patient problems: Reaction

  MAUDE report 7951648 ↗

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