EverFlex™ EVD35-07-040-080Recalls & reported problems
Covidien LP · STENT EVD35-07-040-080 EF ENTRUST V01 · Class 3 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684051207), received between Mar 2, 2026 and Mar 2, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Activation” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
2 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.
Reports received per month
Recalls naming this device
- Jul 14, 2022Open, Classified
Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.
Z-1644-2022 · Root cause: Other · FDA record ↗
Most reported problems
Device problems
- Premature Activation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2026Premature Activation
IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A SOFT TISSUE LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, MID LOCATION, WITH A LESION LENGTH OF 40 MM AND ARTERY DIAMETER OF 6 MM, USING THE EVERFLEX ENTRUST 7X40X80, THERE WAS A DELAY IN SURGERY OF ONE HOUR DUE TO PRODUCT MALFUNCTION. THE STENT WAS DEPLOYED WITHOUT THE THUMB WHEEL BEING USED. THE STENT WAS REMOVED WITHIN THE SHEATH. THE PROCEDURE WAS ABORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24481661 ↗
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-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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.