Abre™ AB9U20100090Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169796454), received between Feb 13, 2023 and Feb 13, 2023 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2023Activation, Positioning or Separation Problem; Physical Resistance/Sticking; Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A ABRE STENT TO TREAT A LESION IN THE LEFT COMMON FEMORAL ARTERY. THERE WAS SEVERE TORTUOSITY. IT WAS REPORTED THAT THERE WAS DEPLOYMENT ISSUES. THE STENT WAS UNABLE TO BE DEPLOYED. THE DEVICE PASSED THOUGH  A PREVIOUSLY DEPLOYED STENT. THE ABRE STENT FAILED TO DEPLOY, PHYSICIAN ENCOUNTERED A LOT OF RESISTANCE WHEN TRYING TO ROTATE THE THUMBWHEEL. APPROX 1CM OF STENT WAS VISIBLE AND WOULD NO LONGER DEPLOY PAST THAT. THE PHYSICIAN REMOVED DEVICE FROM PATIENT AND REPLACED WITH A NON-MEDTRONIC STENT THAT HAD NO ISSUES DEPLOYING. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368881 ↗

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