Abre™ AB9U12060090Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169796225), received between Jul 9, 2021 and Jan 22, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · 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.

• MalfunctionJan 22, 2026Use of Device Problem

  IT WAS REPORTED THAT AN ABRE STENT THAT EXPIRED ON 04-JAN-2026 WAS IMPLANTED IN A PATIENT ON (B)(6) 2026. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24143527 ↗
• InjuryNov 6, 2025Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT SUPERIOR VENA CAVA STENOSIS DUE TO MALIGNANT OBSTRUCTION, THE STENT ABRE 12MM WAS DEPLOYED FROM INTERNAL JUGULAR ACCESS AFTER VESSEL MEASUREMENT WITH INTRAVASCULAR ULTRASOUND AND LOCATION CONFIRMATION WITH FLUOROSCOPY (IVUS MEASURED 9.5MM). THE VESSEL EXHIBITED 90% LESION STENOSIS, A LESION LENGTH OF 50MM, MODERATE CALCIFICATION, AND MINIMAL TORTUOSITY, WITH A REFERENCE VESSEL DIAMETER OF 9.6MM. UPON DEPLOYMENT, THE STENT IMMEDIATELY MIGRATED INTO THE RIGHT ATRIUM AND DID NOT COVER THE LESION. THE STENT WAS SUCCESSFULLY SNARED (GOSSENECK SNARE) AND REMOVED FROM THE BODY VIA FEMORAL VEIN ACCESS, AND INSPECTION CONFIRMED IT WAS FULLY INTACT. THE VESSEL WAS PRE-DILATED WITH A NON-MEDTRONIC (10MM CONQUEST) BALLOON AND POST-DILATED WITH A NON-MEDTRONIC (12MM CONQUEST) BALLOON. A NEW 14X60MM ABRE STENT WAS SUBSEQUENTLY PLACED FROM FEMORAL VEIN ACCESS WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23488068 ↗
• InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO ABRE STENTS SELF-EXPANDING WERE IMPLANTED FOR THE TREATMENT OF A FIBROUS LESION IN THE LEFT COMMON ILIAC VEIN AND LEFT EXTERNAL ILIAC VEIN. THERE WAS MILD TORTUOSITY AND NO CALCIFICATION. THE DEVICES WERE PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED. THE PROCEDURE WAS COMPLETED WITH NO ISSUES MENTIONED. DURING A FOLLOW UP VISIT THE STENTS WERE NOTED TO BE OCCLUDED. REINTERVENTION ON THIS PATIENT WITH THE DOCTOR ON (B)(6) 2023. DURING THE CASE, THE STENTS WERE REOPENED THE BY REMOVING THE PRESENT CLOT WITH ASPIRATIONAL THROMBECTOMY AND USING A HIGH-PRESSURE BALLOON. THE STENTS WERE RE-EVALUATED THAT WERE ORIGINALLY PLACED, AND THE PHYSICIAN HAD THE FOLLOWING CONCLUSIONS: UNSURE ABOUT WHY THE STENTS WENT DOWN. STENTS APPEARED TO BE PROPERLY SIZED ACCORDING TO IVUS ¿ NO SPACE BETWEEN VESSEL WALL AND STENT, NO ¿STEP¿ INTO NATIVE VESSEL WHICH WOULD MEAN AN OVERSIZING. AFTER CLEARING STENTS OF CLOT AND REOPENING, NO COLLATERAL VESSELS APPEARED ON VENOGRAM. THIS LED THE DOCTOR TO BELIEVE THAT THERE ARE NO VESSELS THAT ARE STEALING FLOW FROM THE ILIAC VEINS AFTER THE CASE NO CLINICAL REASON COULD BE CONFIRMED WHY THE STENTS SHUT DOWN AT THAT TIME. PHYSIC

  Patient problems: Obstruction/Occlusion

  MAUDE report 16662501 ↗
• InjuryJul 9, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  PHYSICIAN USED AN ABRE SELF-EXPANDING STENT WITH A 9FR SHEATH DURING TREATMENT OF PROXIMAL LEFT COMMON ILIAC VEIN COMPRESSION, MAY-THURNER SYNDROME. MODERATE VESSEL TORTUOSTY REPORTED. HEALTH TISSUE WAS MEASURING 12 MM ON BOTH DISTAL AND PROXIMAL AREAS, WHERE AREA OF COMPRESSION HAD AVERAGE OF 8.5 MM. 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 AS PREPPED AS PER IFU WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE NOTED DURING ADVANCEMENT. THE DEVICE WAS IMPLANTED WITHOUT ANY ISSUES. PRE-DILATION WAS NOT PERFORMED BUT POST-DILATION WAS PERFORMED WITH 12 MM NON-MEDTRONIC BALLOON. NO DEVIATIONS NOTED DURING THE PROCEDURE. ONE DAY POST PROCEDURE THE PATIENT EXPERIENCED SEVERE CHEST PAINS AND HEART BURN. THE PATIENT IMMEDIATELY ATTENDED THE EMERGENCY ROOM AND ULTRASOUND REVEALED THE STENT HAD MIGRATED TO THE HEART. THE PATIENT WAS SENT TO IR TO HAVE STENT RETRIEVED. STENT RETRIEVAL WAS SUCCESSFUL. THE STENT WAS STUCK IN BETWEEN RIGHT ATRIUM AND RIGHT VENTRICLE IN THE TRICUSPID VALVE. PATIENT WILL RETURN FOR FOLLOW-UP TO SEE IF ANY DAMA

  Patient problems: Chest Pain

  MAUDE report 12141232 ↗

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