Abre™ AB9U16120090Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169796362), received between Dec 30, 2020 and Jul 16, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (3 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.

• InjuryJul 16, 2024Material Deformation; Material Deformation

  PHYSICIAN ATTEMPTED TO IMPLANT AN ABRE SELF-EXPANDING STENT WITH AN 035 GUIDEWIRE DURING PATIENT TREATMENT. MINIMAL VESSEL TORTUOSITY WAS REPORTED. 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. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS POST-DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. STENT DEFORMATION IN VIVO DURING THE PROCEDURE WAS REPORTED. A REPLACEMENT ABRE STENT WAS USED TO RELINE THE DEFECTIVE STENT AND COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750084 ↗
• InjuryNov 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTS THAT SHE HAS A BLOOD CLOT IN THE BRAIN AND HER PHYSICIAN IS INVESTIGATING IF THIS CLOT CAME FROM HER LEG WHERE THEY HAD AN ABRE STENT IMPLANTED ((B)(6) 2023).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18203514 ↗
• InjuryJul 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A ABRE STENT TO USE A ABRE STENT TO TREAT A LESION IN THE LEFT PROXIMAL COMMON ILIAC VEIN AND IVC (INFERIOR VENA CAVA). DEGREE OF TORTUOSITY WAS NONE. DEGREE OF CALCIFICATION WAS NONE. LESION STENOSIS WAS 90%. 9FR SHEATH FRENCH. EMBOLIC PROTECTION WAS NOT USED. DEVICE WAS PREPPED PER IFU. LESION WAS PRE-DILATED.  THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT WAS DEPLOYED. PHYSICIAN ACCESSED CONTRALATERAL SIDE AND ADVANCED J WIRE WITH PIGTAIL CATHETER. THEN, PHYSICIAN WANTED TO EXCHANGE FOR A LONGER WIRE AND LOST ACCESS. WHEN PUTTING THE PIGTAIL CATHETER NEAR THE STENT TO CROSS BESIDE IT AND NOT THROUGH THE STENT HE ENDED UP DISLODGING THE STENT WITH THE PIGTAIL. THE STENT MOVED INTO THE IVC. A 18X100 ABRE STENT WAS USED TO ANCHOR THE 16X120 ABRE AND COVER THE AREA THAT WAS NOW NOT STENTED. APPROXIMATELY 3 CM OF OVERLAP OF THE 18X100 ABRE STENT INTO THE IVC.  ABRE16X120 STENT WAS SUCCESSFULLY DEPLOYED. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17266492 ↗
• MalfunctionNov 18, 2022Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  AN ABRE STENT WAS INTENDED TO BE IMPLANTED FOR THE TREATMENT OF A FIBROUS LESION WITH 70% STENOSIS IN THE MID LEFT EXTERNAL ILIAC VEIN. THE VEIN HAD MODERATE TORTUOSITY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LOCK PIN WAS REMOVED AFTER CROSSING THE LESION ONCE POSITION HAD BEEN CHECKED. RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE. THE ABRE PARTIALLY DEPLOYED AND THE MANUAL DEPLOYMENT WORKAROUND FOR PARTIAL DEPLOYMENT WAS FOLLOWED. WHILE FOLLOWING THE DEPLOYMENT STEPS THE STRING BROKE AND A PIECE OF METAL WIRE BROKE OFF AND IT SEEMED TO FREE UP AND DEPLOY. THE PIECE DID NOT DETACH INSIDE THE PATIENT. THE ABRE WAS DEPLOYED AND PROCEDURE CONTINUED WITH TWO MORE STENTS BEING DEPLOYED WITH NO ISSUES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15824119 ↗
• InjuryOct 17, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A PHYSICIAN WAS IMPLANTING AN ABRE SELF EXPANDING STENT FOR TREATMENT OF AN 100MM SOFT TISSUE LESION WITH 75% STENOSIS IN THE PROXIMAL REGION OF THE RIGHT ILIAC VEIN. A 10 FR NON-MDT SHEATH AND 0.035" NON-MDT GUIDEWIRE WERE USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LOCK-PIN WAS REMOVED PRIOR TO DEPLOYMENT. IT WAS REPORTED THE STENT PARTIALLY DEPLOYED AND WAS THEN EXPLANTED. A NEW STENT WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614189 ↗
• MalfunctionNov 4, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN WAS ATTEMPTING TO USE THE ABRE SELF EXPANDING STENT DURING PROCEDURE TO TREAT NON CALCIFIED SOFT TISSUE LESION IN THE PROXIMAL LEFT COMMON ILIAC VEIN. THE PATIENT HAD A COMPRESSION LESION. THE VESSEL HAD LITTLE TORTUOSITY AND EXHIBITED 60% STENOSIS. THE ARTERY DIAMETER WAS 14MM AND LESION LENGTH WAS 100MM. A NON MEDTRONIC 9FR SHEATH AND GUIDEWIRE WERE 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 WERE DEPLOYMENT ISSUES AND UNABLE TO DEPLOY THE STENT. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE THUMBSCREW WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE LOCK PIN WAS REMOVED AT TIME OF DEPLOYMENT. THE LESION WAS PRE-DILATED WITH A NON MEDTRONIC 14MM BALLOON. THERE WAS RESISTANCE ENCOUNTERED DURING DELIVERY TO LESION AND FORCE WAS APPLIED. THE PHYSICIAN NOTED RESISTANCE WHEN ADVANCING THE THUMBWHEEL TO DEPLOY THE STENT. THE PHYSICIAN WAS NOT HOLDING THE SHAFT OF THE STENT BY THE SHEATH AND WAS ATTEMPTING TO TURN THE THUMBWHEEL BUT COULD NOT ADVANCE IT. THE PHYSICIAN WAS USING A LOT OF FORCE. THE STENT WAS ONLY JUST FLO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751487 ↗
• MalfunctionDec 30, 2020Material Deformation; Material Deformation

  PHYSICIAN USED AN ABRE VENOUS STENT DURING TREATMENT OF A 120MM SOFT TISSUE LESION IN THE PATIENT¿S PROXIMAL, MID, AND DISTAL RIGHT COMMON ILIAC VEIN INTO EXTERNAL ILIAC VEIN. VESSEL DIAMETER REPORTED AS 15MM. MODERATE VESSEL TORTUOSITY IS REPORTED. LESION EXHIBITED 75% STENOSIS. 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 NOT PERFORMED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. THE STENT WAS SAFELY DEPLOYED AND POST-DILATED WITH A NON-MEDTRONIC BALLOON. THE PHYSICIAN HAS REPORTED THE STENT FORESHORTENED A FULL 1.5CM. THE PATIENT¿S OUTCOME IS REPORTED TO BE GOOD. THE ABRE STENT NOT HITTING ITS PLANNED DISTAL MARK WAS NOT REPORTED AS AN OUTCOME ISSUE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11094387 ↗

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