Abre™ AB9U14120090Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169796317), received between Dec 8, 2020 and Aug 14, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (7 reports).

3 other recalls cover devices cleared under the same FDA submission (P200026); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Fracture; Material Deformation

  It was reported that during deployment of an ABRE stent for treatment of non-thrombotic compression in the proximal left common iliac vein, the stent was found to be broken around the top ring of struts. The target was a 10 mm soft-tissue lesion in a 13 mm vessel with minimal tortuosity. The vessel was pre-dilated, no embolic protection was used, and the instructions for use were followed without issue. Stent deformation was reported, with the stent/struts described as deformed before use. The stent could not be retrieved and was fully deployed. Stent correction was needed, and a second Medtronic stent was deployed in the contralateral vein to hold the affected stent in place and prevent embolization. The patient was alive with no further injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254670 ↗
• MalfunctionJan 7, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE PLACEMENT OF AN ABRE STENT IN THE RIGHT PROXIMAL COMMON ILIAC VEIN (CIV) AND EXTERNAL ILIAC VEIN (EIV), DEPLOYMENT ISSUES OCCURRED, AND THE DEVICE WAS UNABLE TO BE DEPLOYED. LESION LENGTH WAS 60MM WITH 100% LESION STENOSIS, ARTERY/VEIN DIAMETER WAS 12MM. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY AND NO ISSUES WHEN REMOVING FROM THE TRAY. THE TARGET LESION WAS DESCRIBED AS FIBROUS WITH 100% STENOSIS, A LENGTH OF 60MM, AND A DIAMETER OF 12MM. IFU WAS FOLLOWED. THE VESSEL WAS PRE-DILATED, VESSEL WAS POST-DILATED USING AN UNKNOWN DILATION DEVICE, AND THE PROCEDURE WAS PERFORMED USING A 9FR NON-MEDTRONIC SHEATH. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE.  THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE AND THE THUMBSCREW/LOCK-PIN WAS REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. IT WAS NOTED THAT STENT STRUTS WERE EXPOSED AND VISIBLE UPON REMOVAL OF THE DEVICE. THE DEVICE WAS SAFELY REMOVED WITHOUT REQUIRING ANY ADDITIONAL INTERVENTION, AND THE PROCEDURE WAS COMPLETED USING A NEW MED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093882 ↗
• MalfunctionJun 8, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A PHYSICIAN WAS ATTEMPTING TO IMPLANT AN ABRE STENT FOR TREATMENT OF A LESION IN THE PROXIMAL REGION OF THE RIGHT COMMON ILIAC VEIN. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED WITH A 16X40 ATLAS BALLOON. THE LOCK PIN WAS REMOVED AFTER ANGIOGRAPHIC PLACEMENT OF DELIVERY SYSTEM CONFIRMED STENT WAS WHERE PHYSICIAN WANTED TO DEPLOY STENT. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT.  IT WAS REPORTED THE STENT BEGAN DEPLOYING CORRECTLY THEN HALF WAY THROUGH STENT DEPLOYMENT THE THUMBWHEEL LOCKED COMPLETELY. THE PHYSICIAN THEN TRIED FORCING THE DELIVERY SYSTEM FORWARD AND BACK BUT IT WOULDN'T BUDGE SO IT TOOK THE HANDLE APART AND FINISHED DEPLOYING THE STENT MANUALLY WITH NO HARM TO STENT OR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17085135 ↗
• MalfunctionMar 2, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO USE AN ABRE SELF-EXPANDING STENT DURING PATIENT TREATMENT. PARTIAL DEPLOYMENT IS REPORTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16465921 ↗
• MalfunctionFeb 13, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A PHYSICIAN ATTEMPTED TO USE AN ABRE STENT TO TREAT THE LEFT, MID CIV, EIV OF A PATIENT. NO CALCIFICATION REPORTED. NO TORTUOSITY REPORTED. PERCENTAGE LESION STENOSIS IS UNKNOWN. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. NO DAMAGE NOTED TO PACKAGING. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU, WITH NO ISSUES IDENTIFIED. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. A 10 FRENCH SHEATH WAS USED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE USED. THE LESION WAS PRE-DILATED WITH A 14MM DEVICE. THERE WAS SUFFICIENT DISTAL LANDING ZONE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED DURING DELIVERY TO LESION. THE LOCK-PIN WAS REMOVED. IT IS REPORTED THAT THE ABRE STENT WOULD NOT DEPLOY - DIFFICULT TACKTILE THUMB WHEEL. THE STENT STARTED TO DEPLOY, SUCH THAT THE MARKERS OF THE STENT WERE EXPOSED BEYOND THE RETRACTABLE SHEATH, BUT NOT APPOSING THE WALL, BEFORE THE PHYSICIAN MADE THE DECISION TO PULL THE SYSTEM OUT DUE TO EXCESSIVE FORCE. THE PHYSICIAN WAS ADVISED TO REMOVE AND DEPLOY NEW STENT. THE STENT WAS PULLED OUT AND REPL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368984 ↗
• MalfunctionJan 25, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AN ABRE STENT WAS INTENDED TO BE IMPLANTED FOR THE TREATMENT OF THE ILIAC VEIN. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LOCK-PIN WAS REMOVED WHEN THE STENT WAS POSITIONED FOR DEPLOYMENT. IT WAS REPORTED THE STENT COULD NOT DEPLOY. ANOTHER ABRE STENT WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED. WHEN THE DEVICE WAS RETURNED, IT WAS NOTED THAT THE STENT WAS EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16239631 ↗
• MalfunctionAug 16, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING PROCEDURE USING AN ABRE SELF-EXPANDING STENT, THE STENT JUMPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12324093 ↗
• MalfunctionDec 8, 2020Malposition of Device; Activation, Positioning or Separation Problem; Material Deformation; Malposition of Device; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN INTENDED TO USE AN ABRE VENOUS STENT WITH A 9FR SHEATH DURING TREATMENT OF THE PATIENT¿S PROXIMAL LEFT COMMON ILIAC VEIN. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED THAT THE PHYSICIAN NOTED THE RETRACTABLE SHEATH SEEMED SLIGHTLY PULLED BACK FROM TIP OF DEVICE, BUT DECIDED IT WAS NEGLIGIBLE AND PROCEEDED WITH DELIVERY. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. THERE WAS ENOUGH DISTAL LANDING ZONE. UPON DELIVERY, PHYSICIAN NOTED THAT THE STENT JUMPED FORWARD AND DISTAL PORTION OF STENT WAS BENT ON AN ANGLE. PHYSICIAN ATTRIBUTED THIS MOVEMENT AND MIS-DEPLOYMENT TO THE STATE OF THE RETRACTABLE SHEATH PRIOR TO DELIVERY. THE STENT PLACEMENT DID NOT COMPROMISE DELIVERY AND THE PHYSICIAN WAS ABLE TO USE A BALLOON TO STRAIGHTEN OUT THE DISTAL PORTION OF THE STENT TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10968180 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P200026. One submission often covers many models, so check the product and lot details in each record.

• Z-1098-2026 · Dec 4, 2025 · Open, Classified
  Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G1410
• Z-0464-2022 · Nov 19, 2021 · Terminated
  Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
• Z-1532-2021 · Mar 16, 2021 · Terminated
  Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous