Abre™ AB9U20150090Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169796478), received between Oct 18, 2023 and Oct 25, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A PHYSICIAN WAS ATTEMPTING TO IMPLANT AN ABRE STENT FOR TREATMENT OF A FIBROUS LESION WITH 70% STENOSIS IN THE LEFT COMMON ILIAC VEIN AND EXTERNAL ILIAC VEIN. THERE WAS SEVERE TORTUOSITY AND NO CALCIFICATION. A 10 FR NON MEDTRONIC SHEATH AND A 0.035 NON MEDTRONIC GUIDEWIRE WERE USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED WITH A 16MM X 40MMPRE-DILATION DEVICE. ACCESS WAS PERFORMED WITH A 10FR SHEATH INSERTED. ANOTHER ABRE 20MM X 150MM WAS OPENED.  A STIFFER WIRE WAS USED TO PROVIDE ADDITIONAL SUPPORT FOR DELIVERY, RESISTANCE WAS MET AGAIN DURING ADVANCEMENT. ONCE THE STENT CATHETER WAS IN POSITION, LOCK PIN WAS REMOVED AND THUMBWHEEL WAS ACTIVATED. THE STENT WAS NOT DEPLOYING AFTER MORE THAN 15 CLICKS OF THUMBWHEEL, STENT CATHETER WAS PULLED BACK AND AGAIN DEPLOYED WHEN OUTSIDE OF SHEATH. PROCEDURE WAS ABORTED WITH NO INJURY TO THE PATIENT OR ANY PART OF EITHER STENT LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18001253 ↗
• MalfunctionOct 18, 2023Fracture; Difficult to Remove; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Fracture; Difficult to Remove; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  A PHYSICIAN WAS ATTEMPTING TO IMPLANT AN ABRE STENT FOR TREATMENT OF A FIBROUS LESION WITH 70% STENOSIS IN THE LEFT COMMON ILIAC VEIN AND EXTERNAL ILIAC VEIN. THERE WAS SEVERE TORTUOSITY AND NO CALCIFICATION. A 10 FR NON MEDTRONIC SHEATH AND A 0.035 NON MEDTRONIC GUIDEWIRE WERE USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED WITH A 16MM X 40MMPRE-DILATION DEVICE. IT WAS REPORTED THE 1ST STENT WAS INSERTED AND POSITIONED IN COMMON ILIAC VEIN, EXTERNAL ILIAC VEIN. RESISTANCE HAD BEEN ENCOUNTERED DURING ADVANCEMENT TO THE LESION. THE DEVICE HAD NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. LOCK PIN WAS REMOVED AND PHYSICIAN BEGAN DEPLOYMENT USING THUMBWHEEL, STENT SHOULD BEGIN FLOWERING AROUND 9 CLICKS BUT THE STENT WAS NOT EXPOSING OUT OF STENT CATHETER AT 20 CLICKS AND THE STENT CATHETER WAS REMOVED AND STENT BEGAN DEPLOYING AS IT APPROACHED THE SHEATH TO BE REMOVED. THIS CAUSED SIGNIFICANT RESISTANCE, DISTAL OR LEADING END OF THE STENT INVERTED AND BROKE. THE STENT DID NOT FULLY DETACH UNTIL WITHIN THE SHEATH. STENT CATHETER, SHEATH, STENT WAS REMOVED FROM PATIENT. NO PART OF THE STENT WAS LEFT INSIDE THE PATIENT.  ACCESS WAS PERF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17959018 ↗

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