Abre™ AB9U12120090Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169796256), received between May 20, 2022 and Aug 11, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  A patient received three Abre Iliac Vein Stents on (b)(6) 2025 for May Thurner Syndrome. The patient has no prior history of Deep Vein Thrombosis and was on anticoagulation therapy after the procedure. On (b)(6) 2025 the patient was prescribed Tranexamic Acid as needed for Menses but was not in use during any stent restenosis events. Months later, the patient reduced the Eliquis dosage to begin a supervised wean. Follow-up imaging showed more than 50% narrowing inside the stents in multiple segments. The patient had balloon angioplasty to open all narrowed segments. Two months later the patient had a second angioplasty because the narrowing returned despite ongoing therapeutic anticoagulation. During that procedure, a localized steroid treatment device was also used. Despite these interventions and anticoagulation, the patient developed additional in-stent restenosis. The patients Physician noted that each recurrence of restenosis consists of blood material buildup rather than scar tissue. A hematology evaluation did not identify any underlying clotting disorder or hematologic cause for the recurrent in-stent restenosis. Concomitant medical products and other treatments include Asp

  Patient problems: Restenosis

  MAUDE report 50207127 ↗
• InjuryJan 23, 2026Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT TREATMENT FOR A LESION IN THE LEFT MID AND DISTAL COMMON AND EXTERNAL ILIAC VEIN USING A 12X120MM ABRE STENT. THE LESION EXHIBITED 90% STENOSIS OVER AN 80MM LENGTH, WITH A VESSEL DIAMETER OF APPROXIMATELY 10MM. MINIMAL VESSEL TORTUOSITY AND MINIMAL VESSEL CALCIFICATION WAS REPORTED. THERE WERE ABNORMALITIES IN RELATION TO ANATOMY, WITH TUMOR COMPRESSION OF LEFT COMMON AND EXTERNAL ILIAC VEIN REPORTED. A 10FR NON-MEDTRONIC SHEATH WAS USED. THE VESSEL WAS PRE-DILATED WITH A 12X40MM NON-MEDTRONIC PTA DILATATION CATHETER. PHYSICIAN CROSSED LESION EASILY DESPITE COMPRESSION. THE ABRE STENT WAS PLACED ACROSS LESION WITHOUT DELIVERY ISSUES. AFTER PLACEMENT, SEVERE COMPRESSION AND DEFORMATION OF THE DISTAL SEGMENT OF THE STENT WERE OBSERVED, INCLUDING PANCAKING AND INCOMPLETE OPENING, AS CONFIRMED BY INTRAVASCULAR ULTRASOUND AND VENOGRAPHY, WHICH ALSO SHOWED DELAYED CONTRAST WASHOUT INDICATING FLOW-LIMITING COMPRESSION. THE VESSEL WAS POST-DILATED WITH 12X40MM NON-MEDTRONIC PTA DILATATION CATHETER, THEN JUST THE DISTAL PORTION OF STENT WAS POST DILATED WITH A 14X40 NON-MEDTRONIC PTA DILATATION CATHETER, BUT SEVERE COMPRESSION PERSISTED. THE COMPRESS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161304 ↗
• InjurySep 12, 2023Malposition of Device; Activation, Positioning or Separation Problem; Malposition of Device; Activation, Positioning or Separation Problem

  A PHYSICIAN WAS IMPLANTING AN ABRE SELF EXPANDING STENT FOR TREATMENT OF A LESION IN THE PROXIMAL REGION OF THE LEFT ILIAC VEIN. THERE WAS MILD TORTUOSITY AND CHRONIC TOTAL OCCLUSION. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LOCK PIN WAS REMOVED PRIOR TO DEPLOYMENT. IT WAS REPORTED THE STENT WAS NOT UNSHEATHING WITH EACH CLICK OF THE WHEEL. WHEN THE PHYSICIAN CONTINUED TO CLICK SEVERAL TIMES, THE ENTIRE STENT CAME OUT AT ONCE CAUSING THE STENT TO JUMP. THE STENT HAD TO BE RE-LINED WITH A SECOND STENT DUE TO THE STENT JUMPING AND POOR PLACEMENT IN THE VEIN. PATIENT HAS THROMBOSED THE INFERIOR VENA CAVA (IVC) AFTER FILTER WAS LEFT IN PLACE TOO LONG.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17729582 ↗
• MalfunctionMay 20, 2022Malposition of Device; Malposition of Device

  PHYSICIAN USED AN ABRE SELF-EXPANDING STENT DURING TREATMENT OF A LESION IN THE PATIENT'S PROXIMAL RIGHT ILIAC VEIN. NO VESSEL TORTUOSITY OR CALCIFICATION REPORTED. LESION EXHIBITED 50% STENOSIS. 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 AS PER IFU WITHOUT ISSUE. PRE-DILATION WAS PERFORMED WITH AN 8MM BALLOON. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. THE PATIENT WAS HYDRATED PRIOR TO THE PROCEDURE. IVUS MEASUREMENTS WERE TAKEN TO DETERMINE STENT SIZING. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO THE PROCEDURE. IT IS REPORTED THE STENT ADVANCED FORWARD 1CM. THE STENT WAS BALLOONED WITH 14MM BALLOON. THE STENT PLACEMENT WAS NOT ADJUSTED AFTER INITIAL FLOWERING OF THE STENT. NO ATTEMPTS WERE MADE TO REMOVE THE STENT. NO DEFORMATION WAS NOTED TO THE DEPLOYED STENT. THE DELIVERY SYSTEM WAS SAFELY REMOVED. THERE WAS NO VESSEL DAMAGE NOTED. A SECOND STENT WAS PLACED IN LEFT COMMON ILIAC FOR TREATMENT, WHICH AIDED THE STENT IN RT. THE SECOND STENT WAS PLANNED. COMMON ILIAC IN PLACE. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14452465 ↗

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