Abre™ AB9U14060090Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169796287), received between Sep 8, 2021 and May 19, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (2 reports).

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

2 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. Dec 4, 2025Open, Classified

   Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.

   Z-1098-2026 · Root cause: Under Investigation by firm · FDA record ↗

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.

• InjuryMay 19, 2023Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  A PHYSICIAN WAS IMPLANTING AN ABRE STENT. A BALLOON WAS INFLATED AND CAUGHT ON THE STRUTS OF THE ABRE STENT, THE BALLOON BECAME STUCK. STENT INTEGRITY WAS LOST ONCE THE BALLOON WAS SUCCESSFULLY REMOVED. THE STENT WAS REPAIRED BY DEPLOYING ANOTHER STENT TO CORRECT IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16962178 ↗
• MalfunctionApr 27, 2022Malposition of Device; Malposition of Device

  A PHYSICIAN IMPLANTED AN ABRE STENT IN THE PROXIMAL LEFT INNOMINATE VEIN OF A PATIENT. THE VESSEL WAS A LITTLE TORTUOUS WITH NO CALCIFICATION. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU, WITH NO ISSUES IDENTIFIED. A 9 FR SHEATH WAS USED. IT IS REPORTED INACCURATE DELIVERY (I.E. STENT DEPLOYED IN UNINTENDED LESION SITE) OF THE DEVICE OCCURRED. THERE WAS SUFFICIENT DISTAL LANDING ZONE. THE LESION WAS NOT PRE-DILATED. HE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED. LYMPHATIC TUMOR WAS PRESSING AGAINST INNOMINATE VEIN. AS STENT WAS BEING DEPLOYED ACROSS THE FOCAL LESION THE STENT JUMPED APPROXIMATELY 2CM INTO THE IVC. STENT WAS POST DILATED WITH EVERCROSS 14MM BALLOON. ANOTHER 14X60 ABRE STENT WAS USED TO EXTEND. STENT WAS THEN POST DILATED WITH 14MM EVERCROSS BALLOON. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14217355 ↗
• MalfunctionOct 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN USED AN ABRE VENOUS SELF-EXPANDING STENT DURING A PROCEDURE. 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. IT IS REPORTED THE PHYSICIAN PERFORMING THE PROCEDURE BELIEVES STENT DELIVERY SYSTEMS INTERNAL STRING RUNNING FROM DELIVERY WHEEL TO DISTAL INTERNAL SHEATH, WHICH HOUSES ABRE STENT, SOME HOW WAS LEFT BEHIND FOLLOWING STENT DEPLOYMENT AND DELIVERY SYSTEM REMOVAL. POST-DILATION WAS PERFORMED THE LEFT BEHIND STRING WAS TANGLED UP IN THE BALLOON AND REMOVED WITH THE BALLOON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12631901 ↗
• InjurySep 8, 2021Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE ABRE SELF-EXPANDING STENT ALONG WITH 9FR SHEATH AND NON-MEDTRONIC GUIDEWIRE DURING PROCEDURE TO TREAT A NONE CALCIFIED FIBROUS LESION IN THE LEFT PROXIMAL EXTERNAL ILIAC VEIN WITH 75% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 12MM AND 100MM RESPECTIVELY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE POST DILATION BALLOON GOT CAUGHT ON STENT AND CAUSED DEFORMATION. THE LESION WAS NOT PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. PHYSICIAN HAD DIFFICULTY ADVANCING BALLOON THROUGH THE STENT TO PROXIMAL POSITION. AFTER FIRST EXPANSION BALLOON WAS DIFFICULT TO RETRACT TO DISTAL POSITION. A NEW STENT WAS PLACED TO CORRECT DEFORMED AREA. DEFORMATION OCCURRED FROM NON-MEDTRONIC BALLOON HAVING LOOSE FIBERS WHICH CAUGHT ON THE STENT UPON REMOVAL. THERE WAS NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12437797 ↗

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-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