Abre™ AB9U18150090Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169796423), received between Apr 27, 2021 and Apr 26, 2024 — classified as 1 injury, 1 malfunction.

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

• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN IMPLANTED AN ABRE SELF-EXPANDING STENT IN THE RIGHT LIAC VEIN, RIGHT SUPERFICIAL VEIN, RIGHT FEMORAL VEIN ((B)(6) 2023). THE LESION WAS REPORTED AS FIBROUS, WITH NO TORTUOSITY OR CALCIFICATION. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. 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. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. EMBOLIC PROTECTION WAS NOT USED. A 9F SHEATH WAS USED. THELESION WAS NOT PRE-DILATED. THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. IT WAS REPORTED POST-OP WHEN THE PATIENT WENT HOME, AFTER THE STENT HAD BEEN IMPLANTED IN THE RIGHT ILEO-FEMORAL SPACE, THEY STARTED COMPLAINING ABOUT PAIN ON THE CONTRALATERAL (LEFT) SIDE. APPROXIMATELY 6 MONTH POST PROCEDURE THE PATIENT WAS TREATED FOR HEAVINESS AND PAIN ON THE LEFT SIDE ((B)(6) 2024).

  Patient problems: Pain

  MAUDE report 19189543 ↗
• MalfunctionApr 27, 2021Material Deformation; Material Deformation

  PHYSICIAN USED AN ABRE STENT WITH A 9FR NON-MEDTRONIC SHEATH DURING TREATMENT OF A 145MM SOFT TISSUE LESION IN THE PATIENT¿S PROXIMAL, MID, AND DISTAL RIGHT COMMON ILIAC VEIN/EXTERNAL ILIAC VEIN. SLIGHT VESSEL TORTUOSITY IS REPORTED. ARTERY DIAMETER REPORTED AS 16MM. LESION EXHIBITED 80% STENOSIS. EMBOLIC PROTECTION WAS NOT USED. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS PERFORMED USING A 16MM PRE-DILATION DEVICE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS NOTED DURING ADVANCEMENT. STENT FORESHORTENING IS REPORTED. A SECOND STENT WAS PLACED TO COVER THE LENGTH NEEDED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11730594 ↗

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