Abre™ AB9U18080090Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169796393), received between Oct 17, 2022 and Feb 7, 2025 — classified as 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2025Premature Activation; Activation, Positioning or Separation Problem; Premature Activation; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE ABRE STENT, THERE WERE DEPLOYMENT ISSUES AS THE DEVICE WAS UNABLE TO DEPLOY. THE STENT STRUTS WERE EXPOSED AND VISIBLE UPON REMOVAL. THE EVENT WAS ASSOCIATED WITH A FIBROUS LESION LOCATED IN THE PERIPHERAL VEIN, SPECIFICALLY THE COMMON ILIAC VEIN. THE VESSEL WAS POST-DILATED, AND THE DEVICE WAS SAFELY REMOVED WITHOUT REQUIRING ANY INTERVENTION. THE PROCEDURE WAS COMPLETED USING A NEW ABRE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332828 ↗
• MalfunctionNov 7, 2024Use of Device Problem; Use of Device Problem

  LIMITED INFORMATION REPORTS THAT AN ABRE STENT WAS IMPLANTED >3MONTHS PAST ITS EXPIRY DATE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20629183 ↗
• InjuryOct 17, 2022Malposition of Device; Material Deformation; Malposition of Device; Material Deformation

  A PHYSICIAN WAS IMPLANTING AN ABRE SELF-EXPANDING STENT FOR THE TREATMENT OF UNKNOWN LESION IN THE LEFT ILIAC VEIN. THE VEIN HAD MILD TORTUOSITY. THE PATIENT HAD HARDWARE IMPEDING ON VEIN. A 9FR NON-MDT SHEATH AND A NON-MDT GUIDEWIRE WERE USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PHYSICIAN VISUALIZED THE MID COMMON ILIAC STENOSIS WITH IVUS AND PRE-DILATED THE VESSEL THE STENT WAS DEPLOYED AND THE VESSEL WAS POST-DILATED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED POST DEPLOYMENT AND THE STENT WAS DEPLOYED AT AN UNINTENDED LESION SITE. ANOTHER ABRE STENT WAS PREPPED FOR DEPLOYMENT WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE DEVICE BROKE AT THE MID POINT OF THE STENT DURING DELIVERY THROUGH THE VESSEL. THE PATIENT WAS PRESCRIBED BLOOD THINNERS AND A CT WAS ORDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15613636 ↗

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