EverFlex™ EVD35-06-100-150Recalls & reported problems
Covidien LP · STENT EVD35-06-100-150 EF ENTRUST V01 · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684051610), received between Jun 28, 2018 and Jun 28, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Inaccurate Delivery” (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
Device problems
- Inaccurate Delivery1
- Kinked1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 28, 2018Kinked; Inaccurate Delivery; Kinked; Inaccurate Delivery
THE PHYSICIAN USED AN EVERFLEX ENTRUST DEVICE WITH A 6FR SHEATH AND 0.014¿ NON-MEDTRONIC GUIDEWIRE FOR THE TREATMENT OF A 30CM CHRONIC TOTAL OCCLUSION (CTO) IN THE PATIENTS MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6MM. LITTLE TORTUOSITY AND LIGHT CALCIFICATION WERE REPORTED. IT IS REPORTED RESISTANCE WAS ENCOUNTERED WHILE THE DEVICE WAS BEING ADVANCED ON THE WIRE. THE STENT WAS SUCCESSFULLY DEPLOYED BUT IT IS REPORTED IT WAS DEPLOYED HIGH. THE PHYSICIAN THEN OPTED TO LINE THE STENT WITH A NON-MEDTRONIC STENT AS A KINK WAS OBSERVED IN THE EVERFLEX ENTRUST. POST STENTING, 50% RESIDUAL STENOSIS REMAINED. NO ADVERSE EVENT OR PATIENT INJURY REPORTED.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7644803 ↗
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 · CompletedProtege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
- Z-1644-2022 · Jul 14, 2022 · Open, ClassifiedEverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
- Z-2048-2016 · May 23, 2016 · TerminatedEV3 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
Other STENT, SUPERFICIAL FEMORAL ARTERY devices
- EverFlex™ EVD35-06-150-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 death110 reports
- SUPERA S-60-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY108 reports
- SUPERA S-55-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY88 reports
- LifeStent® Solo Vascular Stent EX062003CLBard Peripheral Vascular, Inc. · STENT, SUPERFICIAL FEMORAL ARTERY80 reports
- BioMimics 3D Vascular Stent System 144700-12Veryan Medical Limited · Stent, Superficial Femoral Artery74 reports
- SUPERA S-50-120-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY55 reports
- EverFlex™ EVD35-07-120-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
- EverFlex™ EVD35-07-060-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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