Abre™ AB9U20120090Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169796461), received between Jun 22, 2021 and Jun 22, 2021 — classified as 1 injury.

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.

• InjuryJun 22, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PHYSICIAN ATTEMPTED TO USE AN ABRE STENT TO TREAT A THE FIBROUS, CHRONIC TOTAL OCCLUSION IN THE LEFT IVC, COMMON ILIAC VEIN, EXTERNAL ILIAC VEIN. IT IS REPORTED DEPLOYMENT ISSUES WERE ENCOUNTERED AND THE STENT PARTIALLY DEPLOYED. ARTERY DIAMETER WAS 18-19 MM AND LESION LENGTH WAS 180 MM. 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 THE IFU, WITH NO ISSUES IDENTIFIED. LEFT POPLITEAL ACCESS WITH PATIENT PRONE UNDER ULTRASOUND GUIDANCE, 9FR NON-MEDTRONIC SHEATH PLACED. VENOGRAM FROM POPLITEAL TO ILIAC VEINS, SHOWING NO CONTRAST ABOVE MID CFV, WITH LARGE PELVIC VEIN COLLATERAL BRANCHING OFF MEDIAL TO CTO. AFTER UNSUCCESSFUL CANULATION WITH SEVERAL .035 WIRES, AN .018 NON-MEDTRONIC WIRE WAS PASSED SUCCESSFULLY THROUGH THE LEFT ILIAC VEINS INTO THE IVC, WITH HELP OF AN .018 NON-MEDTRONIC CATHETER. SWITCHED TO .035 NON-MEDTRONIC CATHETER TO IVC OVER .035 NON-MEDTRONIC WIRE. 8MMX80MM EVERCROSS BALLOON TRACKED UP TO LEVEL OF DISTAL CIV, WITH NOMINAL PTA INFLATIONS DONE ALONG ENTIRE SEGMENT FROM THAT LOCA

  Patient problems: Foreign Body In Patient

  MAUDE report 12041448 ↗

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