Abre™ AB9U18060090Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169796386), received between May 28, 2021 and Feb 11, 2025 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  AN ABRE SELF-EXPANDING STENT WAS IMPLANTED DURING THE INDEX PROCEDURE IN THE PROXIMAL REGION OF LEFT RENAL VEIN FOR TREATMENT OF A PLAQUE LESION, WHICH WAS OFF-LABEL USE, THE INITIAL CONTEXT INVOLVED STENOSIS OF THE RIGHT RENAL VEIN. IT WAS NOTED 84 DAYS POST PROCEDURE THAT THE STENT HAD SLIGHTLY MIGRATED INTO THE VENA CAVA AND BLOCKED THE GONADAL VEIN. THE STENT WAS SUBSEQUENTLY EXPLANTED/REMOVED; THE SECTION BLOCKING THE GONADAL VEIN WAS REMOVED WITH MAYO SCISSORS AND THEY PATCHED THE CAVA VIA A CUT-DOWN AND RESECTION PROCEDURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21353420 ↗
• MalfunctionMay 7, 2024Malposition of Device; Malposition of Device

  PPHYSICIAN ATTEMPTED TO IMPLANT AN ABRE SELF-EXPANDING STENT WITH A 9FR SHEATH DURING TREATMENT OF A 40MM LESION IN THE PATIENT¿S LEFT PROXIMAL NON-THROMBOTIC ILIAC VEIN LESION (NIVL). VEIN DIAMETER REPORTED AS 16MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. 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 IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE AND THE THUMBSCREW/LOCK-PIN WAS REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE AND POST DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THE STENT FLOWERED PERFECTLY. WHEN PHYSICIAN WAS RETRACTING THE WHEEL, DID NOT HEAR A CLICKING SOUND AND THE STENT JUMPED FORWARD A COUPLE OF MM, KIND OF FELL OFF DELIVERY SYSTEM. THE PHYSICIAN. WAS PULLING BACK THE WHOLE SHAFT WHILE DEPLOYING AND STENT PLACEMENT WAS ADJUSTED AFTER INITIAL FLOWERING. THE STENT DEPLOYED MORE DISTALLY THAN INTENDED, GROIN ACCESS WAS BEING UTILIZED. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19259183 ↗
• InjuryOct 17, 2022Fracture; Fracture

  A PHYSICIAN WAS IMPLANTING AN ABRE SELF-EXPANDING STENT FOR THE TREATMENT OF UNKNOWN LESION IN THE LEFT ILIAC VEIN. THE VEIN HAD MILD TORTUOSITY. THE PATIENT HAD HARDWARE IMPEDING ON VEIN. A 9FR NON-MDT SHEATH AND A NON-MDT GUIDEWIRE WERE USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PHYSICIAN VISUALIZED THE MID COMMON ILIAC STENOSIS WITH IVUS AND PRE-DILATED THE VESSEL THE STENT WAS DEPLOYED AND THE VESSEL WAS POST-DILATED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED POST DEPLOYMENT AND THE STENT WAS DEPLOYED AT AN UNINTENDED LESION SITE. ANOTHER ABRE STENT WAS PREPPED FOR DEPLOYMENT WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE DEVICE BROKE AT THE MID POINT OF THE STENT DURING DELIVERY THROUGH THE VESSEL. THE PATIENT WAS PRESCRIBED BLOOD THINNERS AND A CT WAS ORDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15613684 ↗
• InjuryJul 26, 2021Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN WAS ATTEMPTING TO USE A ABRE STENT FOR PATIENT TREATMENT ON THE LEFT PROXIMAL ILIAC VEIN. THERE WAS LITTLE DEGREE OF TORTUOSITY AND MODERATE DEGREE OF CALCIFICATION. IFU WAS FOLLOWED. NO DAMAGE WAS NOTED ON THE DEVICE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE LESION WAS PRE-DILATED TO 18 MM. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THE PROCEDURE WAS STRAIGHT FORWARD AND SUCCESSFUL. CONCERN AROSE WHEN STENT MIGRATION WAS NOTED IN THE FOLLOW UP. THE STENT HAD MOVED DISTALLY DOWN THE ILIAC VEIN IN THE REVERSE FLOW OF THE VEIN. THE STENT HAD MOVED BELOW A PORTION OF THE LESION AND BEGAN TO THROMBOSIS BOTH ABOVE AND INSIDE OF THE STENT. SUB-ACUTE STENT THROMBOSIS NOTED. THERE WAS NO ADDITIONAL PATIENT INJURY REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12224577 ↗
• DeathMay 28, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHYSICIAN USED AN ABRE SELF-EXPANDING VENOUS STENT SYSTEM WITH A 9FR NON-MEDTRONIC SHORT SHEATH AND 0.035 FLOPPY END GUIDEWIRE DURING TREATMENT OF A 20MM CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S PROXIMAL SUPERIOR VENA CAVA (SVC) DUE TO A PREVIOUSLY PLACED STANDARD INFUSION PORT WHICH WAS REMOVED APPROXIMATELY 2.5 WEEKS PRIOR. VESSEL DIAMETER IS REPORTED AS 16MM. THE PATIENT HAD PREVIOUSLY BEEN TAKING ANTI-COAGULANTS BUT HAD NOT BEEN MEDICATED FOR 2 DAYS PRIOR TO THE PROCEDURE. MEDICATIONS USED DURING THE PROCEDURE REPORTED AS 3MG VERSED, 15MCG FENTANYL AND 50MG BENADRYL. CONSCIOUS SEDATION WAS PERFORMED AND MONITORED. LIMITED ULTRASOUND OF THE NECK AND RIGHT GROIN REVEALED PATENT JUGULAR AND COMMON FEMORAL VEINS (CFV). THE PATIENT WAS PREPPED AND DRAPED IN THE USUAL FASHION. UNDER ULTRASONOGRAPHIC GUIDANCE A MICRO PUNCTURE KIT WAS USED TO ACCESS THE CFV. A 0.018" GUIDEWIRE WAS ADVANCED INTO THE VENA CAVA. THE NEEDLE WAS THEN EXCHANGED FOR A 4FR MICRO PUNCTURE SHEATH. INTERNAL DILATOR AND WIRE WERE REMOVED, AND NON-MEDTRONIC 0.035" GUIDEWIRE WAS ADVANCED INTO THE INFERIOR VENA CAVA. THE MICRO PUNCTURE SHEATH WAS EXCHANGED FOR A 10FR FLUSH SHEATH. IN SIMILAR FASHION, THE R

  Patient problems: Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension; Pain; Swelling/ Edema; Tachycardia

  MAUDE report 11900561 ↗

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