Abre™ AB9U14150090Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169796324), received between May 10, 2021 and Aug 11, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  A patient received three Abre Iliac Vein Stents on (b)(6) 2025 for May Thurner Syndrome. The patient has no prior history of Deep Vein Thrombosis and was on anticoagulation therapy after the procedure. On (b)(6) 2025 the patient was prescribed Tranexamic Acid as needed for Menses but was not in use during any stent restenosis events. Months later, the patient reduced the Eliquis dosage to begin a supervised wean. Follow-up imaging showed more than 50% narrowing inside the stents in multiple segments. The patient had balloon angioplasty to open all narrowed segments. Two months later the patient had a second angioplasty because the narrowing returned despite ongoing therapeutic anticoagulation. During that procedure, a localized steroid treatment device was also used. Despite these interventions and anticoagulation, the patient developed additional in-stent restenosis. The patients Physician noted that each recurrence of restenosis consists of blood material buildup rather than scar tissue. A hematology evaluation did not identify any underlying clotting disorder or hematologic cause for the recurrent in-stent restenosis. Concomitant medical products and other treatments include Asp

  Patient problems: Restenosis

  MAUDE report 50207312 ↗
• MalfunctionAug 5, 2026Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50139170 ↗
• MalfunctionAug 20, 2025Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE OF THE STENT ABRE IN A PROCEDURE INVOLVING THE COMMON AND EXTERNAL ILIAC VEINS, A CATHETER/HANDLE SEPARATION OCCURRED. THE CATHETER HANDLE WAS DELIBERATELY CRACKED TO AID STENT DEPLOYMENT, AND THE STENT WAS SUCCESSFULLY DEPLOYED IN THE TARGET LOCATION USING A WORKAROUND. THE VESSEL WAS POST-DILATED WITH A 12MM NON-MEDTRONIC DEVICE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851258 ↗
• MalfunctionJan 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT POST-IMPLANT THE ABRE STENT WAS NOTED TO HAVE MOVED APPROXIMATELY 20MM PROXIMALLY FROM THE ORIGINAL POSITION. THE PATIENT PRESENTED WITH ONE SIDE WAS NON-INVASIVELY VASCULARIZED, WHILE THE OTHER WAS OCCLUDED. THE RIGHT SIDE HAD 100% STENOSIS WITH A LESION LENGTH OF 140MM AND THE LEFT SIDE HAD 75% STENOSIS WITH LESION LENGTH OF 100MM. KISSING STENTS WERE PLACED IN THE COMMON ILIAC VEINS (CIV), WITH A 14X150 STENT IN THE RIGHT CIV AND A 14X100 STENT IN THE LEFT CIV EIV. THE VESSEL WAS PRE-DILATED. THE PATIENT WAS HYDRATED PRIOR TO PROCEDURE. THE STENTS WERE PREPPED AND DEPLOYED WITHOUT ISSUE USING A 9FR NON-MEDTRONIC SHEATH AND A 260CM NON-MEDTRONIC GUIDEWIRE. THE STENT WAS CONFIRMED TO HAVE PROPER PLACEMENT FOLLOWING DEPLOYMENT. THE STENT DID NOT LAND IN A CURVE. POST-DILATION WAS PERFORMED USING TWO 14X40 NON-MEDTRONIC PTA BALLOONS. ONCE BALLOONING WAS DONE, THE PHYSICIAN NOTICED THE 14X150 ON THE RIGHT HAD MIGRATED 20MM UP. INTRAVASCULAR ULTRASOUND WAS USED FOR IMAGING PRE- AND POST-STENTING. NO INTERVENTION WAS PERFORMED AS A RESULT OF THE STENT MIGRATION. THE DEVICES REMAIN IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103160 ↗
• MalfunctionMar 12, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A ABRE STENT TO TREAT A SOFT TISSUE LESION IN THE RIGHT PROXIMAL CIV. DEGREE OF TORTUOSITY WAS NONE. DEGREE OF CALCIFICATION WAS NONE. LESION STENOSIS WAS 90%. THERE WAS DAMAGE NOTED TO PACKAGING. STERILE POUCH BREACH/DAMAGE. DEVICE WAS PREPPED PER IFU. PHYSICIAN NOTICED A TEAR IN THE PACKAGING AFTER STENT WAS OPENED AND PUT ON STERILE FIELD AND PLACED ON THE WIRE. STENT WAS NOT DEPLOYED IN PATIENT. PATIENT WAS GIVEN ANTIBIOTICS AS PREVENTIVE MEASURE. PROCEDURE WAS COMPLETEDBY OPENING A NEW STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18883940 ↗
• MalfunctionJan 16, 2023Material Deformation; Material Deformation

  A PHYSICIAN WAS IMPLANTING AN ABRE SELF-EXPANDING STENT FOR THE TREATMENT OF A FIBROUS LESION WITH 80% STENOSIS IN THE LEFT COMMON ILIAC VEIN. THERE WAS MILD TORTUOSITY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE STENT WAS DEPLOYED. IT WAS A REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/DEPLOYMENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT USED. AFTER BALLOON, THE PROXIMAL END OF STENT APPEARED TO CHANGE POSITION. IVUS USED AND CONFIRMED STENT OPEN. NO PATIENT INJURY WAS REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16173767 ↗
• InjuryFeb 21, 2022Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE ABRE SELF-EXPANDING STENT ALONG WITH NON-MEDTRONIC 11 FR SHEATH AND 0.035" GLIDEWIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED FIBROUS LESION IN THE LEFT DISTAL COMMON FEMORAL VEIN (CFV). NO EMBOLIC PROTECTION WAS USED. 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. STENT DEFORMATION OCCURRED IN VIVO POST DEPLOYMENT. IT WAS REPORTED THAT A NON-MEDTRONIC 16X6X80 PTA WITH MANUAL ASPIRATION. POST DILATATION MAY NOT HAVE BEEN FULLY DEFLATED AND GOT CAUGHT ON END OF CAUDAL STENT. BALLOON DID NOT POP AND WAS SAFELY REMOVED WITH STENT IN PLACE. THE 14X150 ABRE STENT WAS DEFORMED BY THE NON-MEDTRONIC BALLOON. BALLOON DILATED DEFORMED STENT AND REALIGNED DEFORMED 14X150 WITH A 16X120 ABRE STENT. 16X120 ABRE STENT WAS IMPLANTED TO TREAT THE DEFORMED STENT. NO ISSUES REPORTED POST DILATION OF THIS STENT. THE VESSEL WAS PRE DILATED WITH A 16X5X80 PTA BALLOON. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13568709 ↗
• InjuryJul 27, 2021Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE ABRE STENT DURING PROCEDURE TO TREAT MODERATELY CALCIFIED FIBROUS LESION IN THE LEFT PROXIMAL, MID, DISTAL LOCATION OF THE COMMON ILIAC VEIN. THERE WAS LITTLE TORTUOSITY. IFU WAS FOLLOWED AND THERE WAS NO RESISTANCE ON ADVANCEMENT .IT WAS REPORTED THAT THE ABRE STENT WAS PLACED BUT WAS STUCK AT THE END OF DEPLOYMENT. THE STENT WAS FULLY DEPLOYED BUT IT DID NOT LOOK NORMAL IN THE VESSEL AND WAS REMOVED FROM THE PATIENT. A WALL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231161 ↗
• MalfunctionMay 18, 2021Material Deformation; Material Deformation

  PHYSICIAN USED AN ABRE VENOUS STENT DURING TREATMENT OF A LESION IN THE PATIENT¿S RIGHT COMMON/EXTERNAL ILIAC VEINS. VEIN DIAMETER REPORTED AS 12.5MM. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. LESION PRE-DILATION WAS PERFORMED USING A 12MM PRE-DILATION DEVICE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED WHEN ADVANCING THE DEVICE. THE PHYSICIAN COULD NOT VISUALISE THE STENT WELL DURING DEPLOYMENT. STENT DEFORMATION IS REPORTED IN VIVO DURING POSITIONING/DEPLOYMENT. THE PHYSICIAN BEGAN TO FLOWER THE STENT AND THEN PULLED IT BACK INTO POSITION. EXCESSIVE FORCE WAS USED DURING DELIVERY OF THE DEVICE. THE PHYSICIAN REPORTED THE STENT LOOKED DAMAGED ON THE PROXIMAL END. THE PHYSICIAN THEN CHOSE TO EXTEND THE STENT USING A DIFFERENT SIZED (14 X 60) ABRE. THERE IS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11841555 ↗
• MalfunctionMay 10, 2021Activation, Positioning or Separation Problem; Device Damaged by Another Device; Material Deformation; Activation, Positioning or Separation Problem; Device Damaged by Another Device; Material Deformation

  PHYSICIAN USED AN ABRE SELF-EXPANDING STENT WITH A 9FR SHEATH AND 0.035 GUIDEWIRE DURING TREATMENT OF A FIBROUS LESION IN THE PATIENT¿S MID LEFT COMMON ILIAC VEIN. SLIGHT VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. LESION EXHIBITED 75% STENOSIS. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE PHYSICIAN USED CONTRAST WITH ANGIOGRAPHY TO VISUALIZE THE STENOSED AREA IN LEFT ILIAC VEIN. IVUS WAS USED TO CONFIRM WHERE THE HEALTHY TO HEALTHY, AND STENOSED AREA WAS, AS WELL AS LUMEN MEASUREMENTS TO CONFIRM LEVEL OF STENOSIS. PRE-DILATION WAS NOT PERFORMED. EVERYTHING LOOKED FINE VISUALLY PRIOR TO PLACING THE STENT INTO THE SHEATH. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. THE STENT WAS GUIDED INTO PLACE WITH MINIMAL TORTUOSITY, THE LOCKING PIN WAS THEN REMOVED, AND THE PHYSICIAN BEGAN TO DEPLOY THE STENT AT THE ILIAC VEIN CONFLUENCE. THERE WAS A NON-MEDTRONIC STENT THAT WAS PLACED IN THE PATIENT ON THE RIGHT SIDE FROM A PREVIOUS PROCEDURE. ONCE THE STENT WAS OPENED TO A MARTINI GLASS SHAPE THE TI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11796344 ↗

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