Abre™ AB9U18120090Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169796416), received between May 20, 2021 and Jan 13, 2026 — classified as 1 injury, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Detachment of Device or Device Component

  A PHYSICIAN WAS IMPLANTING AN ABRE STENT. IT WAS REPORTED THE STENT WAS DEPLOYED AND THEN WHILE PULLING OVER THE WIRE THE OUTER LINING OF THE STENT BECAME SEPARATED FROM THE THE INNER ONE. THE INNER LUMEN DISCONNECTED FROM THE WIRE THAT IS CONNECTED TO THE HANDLE. PHYSICIAN WAS ABLE TO GRAB THE DEVICE BEFORE IT RELEASED INTO THE BODY. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24055654 ↗
• MalfunctionOct 4, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN ATTEMPTED TO USE AN ABRE STENT ALONG WITH 9FR NON-MEDTRONIC SHEATH DURING TREATMENT OF FIBROUS LESION IN PATIENTS LEFT PROXIMAL EXTERNAL ILIAC VEIN. 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. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. EMBOLIC PROTECTION WAS NOT USED. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE . THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE AND THE THUMBSCREW/LOCK-PIN WAS REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. IT WAS REPORTED THAT PARTIAL DEPLOYMENT OCCURRED WITHIN THE PATIENT VASCULATURE AND UPON DEPLOYING THE STENT, THE THUMBWHEEL STOPPED WORKING, STENT WAS SUCCESSFULLY REMOVED FROM PATIENT IN TANDEM WITH DELIVERY SYSTEM WITHOUT INJURY/INTERVENTION. THE DEVICE WAS SAFELY REMOVED FROM PATIENT. IT WAS REPORTED THAT A SMALL PORTION OF THE STRUTS WERE EXPOSED UPON REMOVAL FROM PATIENT, AFTER REMOVAL ON THE STERILE FIELD (OUTSIDE OF PATIENT), STAFF FURTHER DEPLOYED STENT TO HALF DEPLOYMENT TO TROUBLESHOOT. NO VESSEL DAMAGE WAS REPORTED. A DIFFERENT ABRE WAS THEN USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20367599 ↗
• InjuryMay 2, 2023Fracture; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Material Deformation; Fracture; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Material Deformation

  A PHYSICIAN WAS IMPLANTING AN ABRE STENT FOR THE TREATMENT OF A FIBROUS LESION WITH 59.6% STENOSIS IN THE PROXIMAL RIGHT REGION OF THE ILIAC VEIN. THE DEGREE OF TORTUOSITY WAS MILD. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE. IT WAS REPORTED THAT THE ABRE WAS DEPLOYED AND IT DID NOT EXPAND IN THE MIDDLE. A 18X60 NON MEDTRONIC BALLOON WAS USED USED TO EXPAND. THE BALLOON BURST AND WAS REMOVED. A 16X60 NON MEDTRONIC BALLOON WAS INSERTED AND INFLATED. IVUS WAS DONE AND 18X120 STENT APPEARED TO BE FRACTURED AND NOT FULLY EXPANDED. THE FRACTURED COMPONENT OF THE STENT DID NOT DETACH. NO DEFORMATION NOTED TO THE DEPLOYED STENT. THE DELIVERY SYSTEM WAS SAFELY REMOVED WITH NO VESSEL DAMAGE AT THIS TIME. AN 18X100 ABRE WAS INSERTED INSIDE THE 18X120 AND POST DILATED WITH 16X60 ATLAS. IVUS WAS USED POST 18X100 AND SHOWED LUMINAL GAIN. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16853306 ↗
• MalfunctionJun 10, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE AN ABRE SELF-EXPANDING STENT ALONG WITH NON-MEDTRONIC 9FR SHEATH AND 0.035 J-WIRE DURING PROCEDURE TO TREAT A LITTLE CALCIFIED FIBROUS LESION IN THE PROXIMAL, MID AND DISTAL COMMON ILIAC TO EXTERNAL WITH 70% STENOSIS. THE VESSEL WAS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 18MM AND 100MM RESPECTIVELY. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. CATHETER/DELIVERY SYSTEM WAS DEFORMED WITH THE TIP STRETCHING. THE LESION WAS PRE DILATED WITH A NON-MEDTRONIC 14X2 DEVICE. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT AFTER DEPLOYMENT OF ABRE, PHYSICIAN FELT RESIDENCE EXISTING SHEATH. COULD NOT REMOVE THE DEPLOYMENT CATHETER. STENT WAS DEPLOYED FINE. HAD TO REMOVE SHEATH AND DEVICE TOGETHER. UPON LOOKING AT CATHETER ONE IS THE SHEATHS OF THE TRIAXIAL SYSTEM WAS DETACHED FROM THE TIP OF THE CATHETER (WHITE) BUT ATTACHED. THE CATHETER DID NOT DETACH IN THE PATIENT. THERE WAS NO VESSEL DAMAGE DUE TO EVENT. THE PROCEDURE WAS COMPLETED WITH THE SAME STENT. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14653840 ↗
• MalfunctionMay 20, 2021Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  PHYSICIAN USED AN ABRE SELF-EXPANDING VENOUS STENT WITH A 9FR SHEATH DURING PATIENT TREATMENT OF THE COMMON ILIAC VEIN. STENOSIS OF THE LESION REPORTED. SLIGHT VESSEL TORTUOSITY IS REPORTED. IFU WAS FOLLOWED. 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. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. PRE-DILATION WAS NOT PERFORMED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. THE LOCK-PIN WAS REMOVED ONCE THE TARGET LESION WAS REACHED. THE STENT WAS SUCCESSFULLY DEPLOYED BUT REPORTED DIFFICULTY WHEN ROTATING THE THUMBWHEEL DUE TO STIFFNESS. IT IS REPORTED THE THUMBWHEEL WAS TOUGH TO ROTATE. THE PHYSICIAN ALSO REPORTED THAT THE LENGTH APPEARED SHORTER THAN 120MM. LENGTH OF DEPLOYED STENT IN VESSEL 120MM. PHYSICIAN REMARKED IT WAS SHORT OF 120MM. STENT PLACEMENT WAS NOT ADJUSTED AFTER INITIAL FLOWERING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853794 ↗

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