Abre™ AB9U20080090Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169796447), received between Jul 27, 2021 and Apr 17, 2025 — classified as 1 death, 1 injury, 2 malfunctions.

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 (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE ABRE STENT WAS NEVER IMPLANTED DUE TO PACKAGING ISSUES DISCOVERED PRIOR TO USE. THE OUTER PACKAGING WAS DAMAGED, AND THE INNER PACKAGING WAS ALSO COMPROMISED. THE STERILE PACKAGING WAS NOT INTACT. THE IFU (INSTRUCTION FOR USE) WASFOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. THE DEVICE WAS NOT USED IN THE PATIENT, AND A NEW ABRE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854410 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTS AN INFECTION THAT SHE BELIEVED WAS CAUSED BY THE ABRE STENT THAT WAS IMPLANTED. PATIENT REPORTS BACK PAIN, SWEATING, PULSING, FEVER, HIVES, AND URINARY TRACT INFECTION. SHE CONTACTED THE PHYSICIAN REGARDING INFECTION AND WAS TOLD THAT THE SYMPTOMS SHOULD SUBSIDE IN 30 DAYS. SHE SAID THEY DID NOT SUBSIDE AND SHE HAS HAD OFF AND ON INFECTION IN HER PELVIS SINCE THE STENT IMPLANT. THE PATIENT ATTENDED A VASCULAR PHYSICIAN TO GET GUIDANCE.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 16013014 ↗
• MalfunctionDec 2, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A PHYSICIAN WAS IMPLANTING AN ABRE SELF-EXPANDING STENT FOR THE TREATMENT OF A SOFT TISSUE LESION WITH (B)(4)% STENOSIS IN THE LEFT MID/ PROXIMAL REGION OF THE COMMON EXTERNAL ILIAC VEIN. THERE WAS MILD TORTUOSITY. A NON-MEDTRONIC 9FR SHEATH WAS USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LOCK-PIN WAS REMOVED AFTER ADVANCING TO THE LESION PRIOR TO DEPLOYMENT. IT WAS REPORTED THE PROXIMAL 15 MM OF THE STENT DID NOT INITIALLY EXPAND SO THE DELIVERY SYSTEM COULD NOT BE REMOVED FROM THE PATIENT FOR A FEW MINUTES UNTIL THE STENT POPPED OPEN. THE SHEATH WAS SLIGHTLY KINKED (NON- MEDTRONIC SHEATH). THE PHYSICIAN ALSO DID NOT PRE-DILATE. DUE TO NITINOL MATERIAL AND PERHAPS RADIAL STRENGTH, THE TOP OF THE STENT EVENTUALLY POPPED OPEN. THIS WAS AFTER APPROXIMATELY 5 MINUTES OF WIGGLING AROUND THE DELIVERY SYSTEM/ADVANCING IT FORWARD AND BACKWARDS GENTLY. ONCE STENT FULLY EXPANDED AND DELIVERY CATHETER WAS REMOVED WITH DIFFICULTY FROM THE PATIENT AND POST DILATED WITH AN 18X60 ATLAS BALLOON. NO DEFORMATION WAS NOTED TO THE DEPLOYED STENT. CONFIRMED STENT PLACEMENT WITH IVUS AND CLOSED WITH MANUAL PRESSURE. THERE WAS NO VESSEL DAMAGE. NO PATIENT INJURY WAS REPORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15903242 ↗
• DeathJul 27, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHYSICIAN IMPLANTED ABRE SELF-EXPANDING STENT IN THE MID TO PROXIMAL SUPERIOR VENA CAVA (SVC) WITH 80-90% STENOSIS DURING PROCEDURE. THE VESSEL HAD LITTLE TORTUOSITY. THE VESSEL DIAMETER IS REPORTED AT 22 - 18MM AND LESION LENGTH AS 60MM. DURING PROCEDURE, NON-MEDTRONIC 9FR SHEATH AND GLIDEWIRE WERE USED. NO EMBOLIC PROTECTION USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE WAS NO ALLEGED PRODUCT ISSUE. THE LESION WAS PRE DILATED USING A NON-MEDTRONIC 20X40 PTA BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT A 20X40 NON-MEDTRONIC BALLOON WAS UTILIZED TO PRE-DILATE THE LESION. THE FIRST 9FR 23 CM NON-MEDTRONIC BRITE TIP SHEATH WAS REMOVED BECAUSE THE NON-MEDTRONIC BALLOON AFTER DILATION WOULD NOT RETRACT FROM THE SHEATH AND WAS STUCK IN IT. A SECOND SHEATH WAS INSERTED AND A SECOND NEW 20X40 NON-MEDTRONIC BALLOON WAS USED. THE 20X80 ABRE STENT WAS THEN PLACED WITH VERY GOOD SUCCESS AND THEN WAS POST-DILATED WITH THE 20X40 NON-MEDTRONIC BALLOON. THERE WERE NO ABNORMALITIES AN

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Obstruction/Occlusion; Pericardial Effusion

  MAUDE report 12231684 ↗

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