Abre™ AB9U16100090Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169796355), received between Jan 28, 2021 and Aug 12, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE USING THE ABRE STENT IN THE LEFT COMMON ILIAC VEIN, IMAGING AND TESTING DOCUMENTED A LESION WITH 55% STENOSIS, 60 MM LENGTH, 12.5 MM DIAMETER, MINIMAL TORTUOSITY, AND MINIMAL CALCIFICATION. THE PHYSICIAN DELIVERED THE STENT ACROSS THE LESION, REMOVED THE LOCKING PIN, AND BEGAN DEPLOYMENT USING THE THUMBWHEEL, WHICH BECAME STUCK AFTER APPROXIMATELY 25% DEPLOYMENT. ATTEMPTS TO LOOSEN THE THUMBWHEEL WERE UNSUCCESSFUL, SO THE HANDLE WAS TAKEN APART AND THE STENT WAS MANUALLY DEPLOYED. THE ABRE DELIVERY CATHETER WAS REMOVED, AND THE STENT WAS POST-DILATED USING A NON-MEDTRONIC BALLOON. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS, AND THE STENT REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22782838 ↗
• InjuryJul 2, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT AN 80% STENOSIS WITH MINIMAL TORTUOSITY AND MINIMAL CALCIFICATION IN THE LEFT COMMON ILIAC VEIN AND EXTERNAL ILIAC VEIN USING THE STENT ABRE, THERE WAS A 20-MINUTE DELAY IN SURGERY DUE TO PRODUCT MALFUNCTION. AFTER THE FIRST STENT WAS DEPLOYED AND POST-DILATED WITH A 16MM X 40MM NON-MEDTRONIC BALLOON, ANGIOGRAPHIC IMAGING REVEALED THAT THE STENT WAS FRACTURED IN THE MIDSEGMENT AND THE STENT/STRUTS WERE DEFORMED IN VIVO. THE PHYSICIAN REALIGNED THE FRACTURED STENT WITH A SECOND 16X100 ABRE STENT. THE FRACTURED STENT REMAINS IN THE PATIENT BUT WAS REALIGNED WITH ANOTHER STENT, AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385862 ↗
• MalfunctionJan 28, 2023Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  A PHYSICIAN WAS USING AN ABRE STENT FOR THE TREATMENT OF A 100MM SOFT TISSUE LESION WITH ESTIMATED 70% COMPRESSION (MAY THURNER SYNDROME) IN THE PROXIMAL REGION OF THE COMMON ILIAC VEIN. THE ARTERY DIAMETER WAS 15MM. A 6FR SHEATH WAS USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE VESSEL WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE LOCK PIN WAS REMOVED PRIOR TO DEPLOYMENT. IT WAS REPORTED THE STENT PARTIALLY DEPLOYED. THE STENT HAD STARTED TO FLOWER AND THE THUMBWHEEL BECAME DIFFICULT TO MOVE AND THE STENT WOULD NOT OPEN. PHYSICIAN CONTINUED ADVANCEMENT OF WHEEL WITH STENT NOT OPENING FOR SEVERAL CM OF STENT. AS WHEEL CONTINUED TO BE ADVANCED THE STENT STARTED TO OPEN UP PAST UNOPENED SEGMENT FORMING A WAIST IN THE STENT. AFTER SEVERAL POST BALLOON DILATIONS THE STENT OPENED AND FUNCTIONED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261466 ↗
• MalfunctionSep 13, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A PHYSICIAN WAS IMPLANTING AN ABRE SELF-EXPANDING STENT FOR THE TREATMENT OF A FIBROUS LESION WITH 55% STEBOSIS IN THE LEFT COMMON ILIAC VEIN, LEFT EXTERNAL ILIAC VEIN, LEFT COMMON FEMORAL VEIN. THERE WAS MILD TORTUOSITY. THE VEIN WAS 16MM IN DIAMETER AND THE LESION LENGTH WAS 190MM. A 9FR NON-MDT SHEATH WAS USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. NO RESISTANCE WAS ENCOUNTERED DURING DELIVERY TO THE LESION. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE LOCK-PIN WAS REMOVED AFTER INSERTION PRIOR TO DEPLOYMENT. THE LESION WAS PRE DILATED WITH A 16MM NON-MDT DEVICE. IT WAS REPORTED THE STENT PARTIALLY DEPLOYED AND THE PHYSICIAN HAD TO BREAK OPEN THE HANDLE OF THE DELIVERY CATHETER TO MANUALLY DEPLOY THE STENT FROM THE TRIAXIAL SYSTEM. THE STENT WAS THEN DEPLOYED WITH NO ISSUES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410996 ↗
• InjuryDec 3, 2021Difficult to Advance; Difficult to Advance

  PHYSICIAN WAS ATTEMPTING TO USE AN ABRE SELF-EXPANDING STENT DURING PROCEDURE TO TREAT A NONE CALCIFIED LESION WITH NO PLAQUE OR FIBROUS WITH 87% STENOSIS. THE VESSEL WAS LITTLE TORTUOUS. DURING INDEX PROCEDURE, A 16X100 ABRE STENT WAS IMPLANTED. THE LESION WAS PREDILATED. A RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE WITH NO FORCE USED. THROMBUS NOTED POST STENT IMPLANTATION. TWO WEEKS POST INDEX PROCEDURE, PATIENT CAME IN FOR A THROMBECTOMY, BUT HAVE IMAGES WERE TAKEN AND PHYSICIAN NOTICES THAT THROMBUS HAD CLEARED UP. THROMBUS CLEARED PRIOR TO SECOND PROCEDURE. ANGIOGRAPHY ON PROPOSED DATE OF THROMBECTOMY DID NOT SHOW THE STENT COMPRESSED/DEFORMED BUT DID NOTICE COMPRESSION TO THE EIV AND A SECOND STENT WAS DEPLOYED. SECOND STENT WAS SUCCESSFULLY IMPLANTED. THERE WAS NO FURTHER PATIENT INJURY.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 12923231 ↗
• InjuryOct 15, 2021Entrapment of Device; Activation, Positioning or Separation Problem; Material Deformation; Entrapment of Device; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN USED AN ABRE VENOUS SELF-EXPANDING STENT DURING A PROCEDURE TO TREAT A LESION IN THE PATIENT'S DISTAL LEFT ILIAC VEIN CONFLUENCE TO LEFT EXTERNAL ILIAC. LITTLE TORTUOUS, NON CALCIFIED, PRESENTING WITH 76.6%. NO ABNORMALITIES RELATED TO ANATOMY. THE LESION WAS PREDILATED. 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 THE IFU WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THOUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING DEVICE. NO EXCESSIVE FORCE USED. THE LOCK-PIN WAS REMOVED PRIOR TO ATTEMPTED DEPLOY PER IFU. IT IS REPORTED THERE WAS DIFFICULTY WHEN DEPLOYING THE STENT, THE STENT COULD NOT BE FULLY DEPLOYED AND PARTIALLY DEPLOYED AND DEFORMED. FOLLOWING POST-DILATION WITH A BALLOON, THE BALLOON BECAME STUCK IN THE PARTIALLY DEPLOYED STENT AND WAS UNABLE TO BE RETRIEVED WITHOUT RISK OF PULLING THE STENT INTO THE IVC. AT THE STENT IMPLANT SITE THE LESION WAS NOT COMPRESSED OR HAD ANY LESION FIBROTIC, PLAQUE. ACCESS WAS GAINED FROM THE GROIN AND A SNARE WAS USED TO GRAB THE BALLOON, CUTTING ITS HUB AT THE IJV AND REMOVING THROUG

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12638745 ↗
• MalfunctionJan 28, 2021Material Deformation; Material Deformation

  PHYSICIAN INTENDED TO USE AN ABRE VENOUS SELF-EXPANDING STENT DURING TREATMENT OF A SOFT TISSUE CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S PROXIMAL LEFT COMMON ILIAC VEIN. MODERATE VESSEL TORTUOSITY AND NO CALCIFICATION ARE REPORTED. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS PERFORMED USING A 10MM PRE-DILATION DEVICE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/DEPLOYMENT IN THE TARGET AREA. IT IS REPORTED THAT 100MM OF THE STENT DEPLOYED IN THE VESSEL. NO SECOND DEVICE WAS USED AND NO INTERVENTION WAS REQUIRED. THERE IS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11242802 ↗

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