Abre™ AB9U14100090Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169796300), received between Jan 11, 2022 and Aug 18, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionAug 18, 2026Activation, Positioning or Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50300095 ↗
• InjuryJan 29, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT A PHYSICIAN PLACED A 14X100MM ABRE STENT TO TREAT A RIGHT COMMON ILIAC VEIN STENOSIS AS PART OF A PULMONARY EMBOLISM THROMBECTOMY AND THE STENT MIGRATED THE FOLLOWING MORNING. MINIMAL VESSEL TORTUOSITY WAS REPORTED. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS POST-DILATED. THE PATIENT CLINICAL PRESENTATION AT THE TIME OF IMPLANT WAS PULMONARY EMBOLISM (PE). THE LESION LOCATION AND LOCATION OF STENT PLACEMENT WAS THE EXTERNAL ILIAC VEIN (EIV). THE PATIENT WAS HYDRATED PRIOR TO PROCEDURE. AN ANGIOGRAM WAS USED FOR IMAGING, AND THE DEGREE OF STENOSIS WAS >50%. THE STENT DID NOT LAND IN A CURVE. THE STENT WAS CONFIRMED TO HAVE PROPER PLACEMENT FOLLOWING DEPLOYMENT. THE STENT MIGRATED TO THE HEART. THE STENT WAS EXPLANTED FROM THE HEART, ILAC LEFT ALONE. THE PATIENT REQUIRED PROLONGATION OF EXISTING HOSPITALIZATION.

  Patient problems: Insufficient Information

  MAUDE report 24209646 ↗
• MalfunctionNov 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A AB9U14100090 ABRE STENT TO TREAT A SOFT TISSUE LESION IN THE PROXIMAL MID DISTAL RIGHT AND LEFT COMMON ILIAC VEIN (CIV), EXTERNAL ILIAC VEIN (EIV). DEGREE OF TORTUOSITY WAS MINIMAL. DEGREE OF CALCIFICATION WAS MINIMAL. STENOSIS 79% RIGHT ILIAC AND 82% LEFT ILIAC. ARTERY/VEIN DIAMETER WAS 113MM2 LEFT ILIAC AND 123MM2 RIGHT ILIAC. HIGH GRADE NONTHROMBOTIC ILIAC VEIN LESIONS (NIVL) COMPRESSIONS BILATERALLY. BOTH RIGHT AROUND 80%. 9F TERUMO PINNACLE SHEATHS WERE USED BILATERALLY, .035 X 260CM BOSTON SCIENTIFIC AMPLATZ SUPERSTIFF GUIDEWIRES WERE USED BILATERALLY. VESSEL WAS PRE-DILATED. 14X40 BARD ATLAS BALLOONS WERE USED BILATERALLY FOR PRE-DILATION AND POST-DILATION. STENT WAS MAL-POSITIONED BETWEEN INNER SHAFT AND RETRACTABLE SHEATH. DEVICE UNBOXED, UNPACKED, AND FLUSHED WITHOUT INCIDENT. WHILE POSITIONING STENT SYSTEM IN THE PATIENT UNDER FLUOROSCOPY, PHYSICIAN NOTICED CONSIDERABLE DISTANCE BETWEEN THE RADIOPAQUE MARKER ON THE RETRACTABLE SHEATH AND THE LEADING EDGE OF THE STENT ITSELF. OUT OF AN ABUNDANCE OF CAUTION, DECISION WAS MADE TO REMOVE THE FULLY INTACT STENT SYSTEM FROM THE PATIENT AND PROCEED WITH ANOTHER ABRE STENT OF SIM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23665687 ↗
• MalfunctionJan 11, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance

  PHYSICIAN WAS ATTEMPTING TO USE THE ABRE SELF EXPANDING STENT DURING PROCEDURE TO TREAT LITTLE CALCIFIED FIBROUS LESION IN THE LEFT ILLIAC VEIN. THE VESSEL HAD NO TORTUOSITY. A 9FR SHEATH WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. IT WAS REPORTED THAT THERE WAS DIFFICULTY REMOVING THE DEVICE FOLLOWING STENT DEPLOYMENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE STENT WAS DEPLOYED SUCCESSFULLY, WHEN REMOVING THE DEPLOYMENT SYSTEM THE WHITE INNER SHEATH DETACHED FROM THE BLUE PORTION. IT CAME OUT IN TWO PIECES. THE PHYSICIAN THAT EVERYTHING WAS OUT OF THE PATIENT BUT HE DID EXPERIENCE SOME FRICTION UPON MOVING THE DELIVERY SYSTEM INTO PLACE, THEN AGAIN WHEN REMOVING IT. THE STENT DEPLOYED PROPERLY. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13222128 ↗

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