Abre™ AB9U18100090Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169796409), received between Dec 8, 2021 and Apr 4, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 16, 2024Open, Classified

   There is a potential for sterile package breach.

   Z-1317-2024 · Root cause: Process control · FDA record ↗

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 4, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  A MEDTRONIC ABRE SELF-EXPANDING STENT WAS IMPLANTED IN THE LEFT ILIAC VEIN OF A PATIENT TO CORRECT LEG DISCOMFORT CAUSED BY MAY-THURNER SYNDROME. OVER THE NEXT 36 HOURS THE PATIENT BEGAN TO EXPERIENCE SHORTNESS OF BREATH, TACHYCARDIA, AND RIGHT SHOULDER PAIN. UPON INFORMING THEIR PROVIDER THE PATIENT WAS INSTRUCTED TO GO TO THE EMERGENCY DEPARTMENT. IMAGING IN THE EMERGENCY DEPARTMENT INDICATED THAT THE STENT MIGRATED TO THE PATIENT¿S HEART AND WAS IN THEIR RIGHT ATRIUM AND RIGHT VENTRICLE. THE PATIENT UNDERWENT SURGERY, AND THE STENT WAS REMOVED WITHOUT RESORTING TO OPEN HEART SURGERY (4 DAYS POST IMPLANT). DOCTORS SUSPECT THERE MAY BE DAMAGE TO THE TRICUSPID VALVE. PATIENT WAS DISCHARGED FROM THE HOSPITAL. X-RAY AND CAT(COMPUTERIZED AXIAL TOMOGRAPHY) SCAN CONFIRMED LOCATION OF STENT IN THE HEART. INCREASED TROPONIN LEVELS WERE ALSO NOTED UPON ADMISSION TO THE EMERGENCY DEPARTMENT. HEART RATE PRIOR TO SURGERY AVERAGED 130 BPM AND SEVERAL EPISODES OF V-TACH WERE RECORDED IN THE EMERGENCY DEPARTMENT AND UPON ADMISSION. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: Dyspnea; Pain; Tachycardia

  MAUDE report 16674021 ↗
• MalfunctionDec 8, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO USE THE ABRE SELF EXPANDING STENT DURING PROCEDURE TO TREAT SOFT TISSUE LESION IN THE DISTAL LEFT COMMON ILIAC VEIN. THERE WAS NO CALCIFICATION. THE VESSEL HAD MODERATE TORTUOSITY AND EXHIBITED 60% STENOSIS. THE ARTERY DIAMETER WAS 16MM AND LESION LENGTH WAS 80MM.A 9FR SHEATH AND NON MEDTRONIC GUIDEWIRE WERE USED. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. IT WAS REPORTED THERE WERE DEPLOYMENT ISSUES WITH PARTIAL DEPLOYMENT. THE STENT WHEEL BROKE AFTER 4 TO 6 CLICKS DURING DEPLOYMENT. THE THUMBSCREW WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE AND THE LOCK-PIN WAS REMOVED PRIOR TO DEPLOYING. THE LESION WAS PRE-DILATED WITH A NON MEDTRONIC 18MM DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE STENT WAS PARTIALLY DEPLOYED AT TARGET SITE. STENT STRUTS WERE EXPOSED IN THE PATIENT DURING DEPLOYMENT ATTEMPT. STRUTS WERE EXPOSED DURING REMOVAL. NO VESSEL DAMAGE WAS NOTED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE STENT WAS PULLED OUT WITH THE SHEATH THROUGH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12959073 ↗

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