Abre™ AB9U20060090Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169796430), received between Aug 15, 2023 and Apr 1, 2026 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Material Deformation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  ABSTRACT ESSENTIALLY ALL ENDOVASCULAR STENTS, BOTH STAINLESS STEEL AND NITINOL, CONTAIN A NICKEL COMPONENT. INCIDENCE OF NICKEL HYPE RSENSITIVITY IS COMMON, BUT NICKEL HYPERSENSITIVITY DOES NOT ALWAYS RESULT IN CLINICALLY SIGNIFICANT REACTIONS. THIS 43- YEAR-OLD WOMAN PRESENTED WITH HIVES, URTICARIA, AND MALAISE AFTER NITINOL STENT PLACEMENT IN HER LEFT ILIAC VEIN FOR MAYTHURNER SYNDROME. SHE UNDERWENT OPEN STENT EXPLANATION AND RECONSTRUCTION OF HER INFERIOR VENA CAVA AND LEFT COMMON ILIAC VEIN WITH SUBSEQUENT RESOLUTION OF SYMPTOMS. THE LOW INCIDENCE OF STENT-RELATED ALLERGY DOES NOT WARRANT PREOPERATIVE TESTING, BUT WE ADVOCATE FOR THOROUGH PREPROCEDURAL DISCUSSION IN HIGH-RISK PATIENTS. FOR SYMPTOMATIC PATIENTS, EXPLANATION CAN BE EFFECTIVE. THE PATIENT IS A 43-YEAR-OLD WOMAN WITH A HISTORY OF LEFT LOWER EXTREMITY VENOUS INSUFFICIENCY AND DEEP VENOUS THROMBOSIS (DVT) SECONDARY TO ORAL CONTRACEPTIVE USE. SHE RECEIVED A NITINOL CONTAINING ABRE (MEDTRONIC) LEFT ILIAC VEIN STENT FOR PRESUMED MAY-THURNER SYNDROME AT AN OUTSIDE FACILITY. IMMEDIATELY AFTER IMPLANTATION, SHE DEVELOPED MULTIFOCAL FACIAL EDEMA, HIVES, AND URTICARIA. SHE WAS SEEN BY AN ALLERGIST WHO DIAGNOSED HER WITH A N

  Patient problems: Local Reaction; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 24751909 ↗
• DeathAug 15, 2023Material Deformation; Material Deformation

  A PHYSICIAN WAS ATTEMPTING TO IMPLANT AN ABRE STENT FOR THE TREATMENT OF A SOFT TISSUE LESION IN THE DISTAL REGION OF THE SUPERIOR VENA CAVA (SVC). THERE WAS MODERATE TORTUOSITY AND NO CALCIFICATION. ABNORMALITIES RELATING TO THE ANATOMY INCLUDED THE PATIENT HAD SVC SYNDROME WITH A TUMOR PRESSING ON SVC AND STENOSED SVC TO ALMOST TOTAL OCCLUSION. THE DEVICE WAS PREPPED AS PER THE IFU. THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. THE PHYSICIAN ACCESSED THROUGH THE LEFT BRACHIAL AND GROIN, THROUGH AND THROUGH WIRES. THE PHYSICIAN PERFORMED THROMBECTOMY USING NON MEDTRONIC DEVICE. PRE-DILATED USING 8MM BALLOON ON THE STENOSED VESSEL. IVUS WAS USED TO MEASURE. THE DEVICE WAS USED OFF-LABEL. THE PHYSICIAN DEPLOYED THE ABRE STENT FROM THE GROIN THROUGH SVC. IT IS REPORTED THERE WAS STENT DEFORMATION IN VIVO POST DEPLOYMENT. STENT APPEARED STRUCTURED AT DISTAL END, POST BALLOON DILATION. UPON POST DILATION OF THE STENOSIS WITH A 16 MM NON-MEDTRONIC BALLOON, THE SVC DISSECTED. THE PHYSICIAN PLACED COVERED STENT ACROSS STENOSIS. THE PATIENT IS DECEASED. CAUSE OF DEATH IS REPORTED AS SVC RUPTURED UPON POST DILATION WITH NON-

  Patient problems: Vascular Dissection

  MAUDE report 17548020 ↗

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