Abre™ AB9U10060090Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169796164), received between Aug 31, 2023 and Aug 31, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2023Use of Device Problem; Use of Device Problem

  A PHYSICIAN WAS IMPLANTING AN ABRE SELF-EXPANDING STENT FOR THE TREATMENT OF A SOFT TISSUE LESION IN THE SUPERIOR VENA CAVA (SVC). ABNORMALITIES WERE REPORTED IN RELATION TO ANATOMY, TUMOR COMPRESSION. A 9FR SHEATH WAS USED. THE ABRE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED.  THE PROCEDURE WAS COMPLETED AS NORMAL WITH NO DIFFICULTIES EXPERIENCED. IT WAS REPORTED THAT THE IMPLANTED STENT HAD EXPIRED ON THE (B)(6)2023 AND IT WAS IMPLANTED ON THE (B)(6) 2023. IT WAS NOT KNOWN OR ANNOUNCED TO THE TEAM UNTIL AFTER THE PROCEDURE THAT THE STENT WAS EXPIRED. THERE WERE NO OTHER STENTS OF THAT SIZE AVAILABLE AT THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17660962 ↗

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