Abre™ AB9U12100090Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169796249), received between Dec 15, 2021 and Jan 13, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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, 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 A PROCEDURE INVOLVING THE DEPLOYMENT OF AN ABRE STENT IN THE LEFT PROXIMAL MID DISTAL COMMON ILIAC VEIN (CIV) AND EXTERNAL ILIAC VEIN (EIV), THERE WERE ISSUES WITH THE DEVICE. A 9FR NON-MEDTRONIC SHEATH AND A 260CM .035 NON-MEDTRONIC GUIDEWIRE WERE USED. AFTER A COUPLE OF ROTATIONS 2MM OF THE STENT DEPLOYED THEN THE THUMB WHEEL KEPT SPINNING WITHOUT PULLING BACK THE ISOLATION SHEET, REQUIRING MANUAL INTERVENTION TO DEPLOY THE STENT. THE PHYSICIAN TOOK APART THE HANDLE TO PULL THE WIRE TO RELEASE THE STENT BUT THIS WAS UNSUCCESSFUL. THIS RESULTED IN A 10-MINUTE DELAY IN THE SURGERY. THE LESION WAS CHARACTERIZED BY 100% STENOSIS, A LENGTH OF 100 MM, A DIAMETER OF 10 MM, MINIMAL TORTUOSITY, AND WAS A SOFT TISSUE TARGET LESION. THE PROCEDURE INVOLVED PRE-DILATION AND POST-DILATION USING A 12X80 EVERCROSS DEVICE. THE STENT WAS SUCCESSFULLY DEPLOYED BY MANUALLY UNSHEATHING THE STENT AND PULLING BACK THE SILVER ISOLATION SHEATH TO DEPLOY THE STENT. THE DELIVERY SYSTEM 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 21136691 ↗
• MalfunctionNov 18, 2024Malposition of Device; Difficult to Advance; Positioning Problem; Malposition of Device; Difficult to Advance; Positioning Problem

  A PHYSICIAN WAS ATTEMPTING TO USE AN ABRE STENT FOR TREATMENT OF A LESION IN THE MID RIGHT GREAT SAPHENOUS VEIN (GSV). THERE WAS MINIMAL TORTUOSITY AND CALCIFICATION. A 10CM 10FR NON-MEDTRONIC SHEATH AND A 260CM 0.035" NON-MEDTRONIC GUIDEWIRE WERE USED. THE IFU WAS FOLLOWED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED ABRE STENT. SEVERE RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT WAS REPORTED THE DEVICE WOULD NOT ADVANCE INTO DESIRED DEPLOYMENT LOCATION. WHEN ATTEMPTING TO REMOVE FROM THE PATIENT, THE STENT DEPLOYED UNINTENTIONALLY OUTSIDE OF THE TARGET SITE PRIOR TO REMOVAL FROM THE SHEATH. THE STENT DEPLOYED MORE DISTALLY THAN INTENDED AND REMAINS IN THE PATIENT. THERE WAS NOTHING UNUSUAL AROUND THE LANDING ZONE OF THE STENT. NO INJURY OR INTERVENTION AS A RESULT. THE DELIVERY SYSTEM WAS SAFELY REMOVED. A 14X60 PROTEGE GPS STENT WAS USED TO COMPLETE THE TREATMENT OF THE LESION. 5 MINUTE DELAY DUE TO PRODUCT MALFUNCTION. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20703895 ↗
• InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO ABRE STENTS SELF-EXPANDING WERE IMPLANTED FOR THE TREATMENT OF A FIBROUS LESION IN THE LEFT COMMON ILIAC VEIN AND LEFT EXTERNAL ILIAC VEIN. THERE WAS MILD TORTUOSITY AND NO CALCIFICATION. THE DEVICES WERE PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED. THE PROCEDURE WAS COMPLETED WITH NO ISSUES MENTIONED. DURING A FOLLOW UP VISIT THE STENTS WERE NOTED TO BE OCCLUDED. REINTERVENTION ON THIS PATIENT WITH THE DOCTOR ON (B)(6) 2023. DURING THE CASE, THE STENTS WERE REOPENED THE BY REMOVING THE PRESENT CLOT WITH ASPIRATIONAL THROMBECTOMY AND USING A HIGH-PRESSURE BALLOON. THE STENTS WERE RE-EVALUATED THAT WERE ORIGINALLY PLACED, AND THE PHYSICIAN HAD THE FOLLOWING CONCLUSIONS: UNSURE ABOUT WHY THE STENTS WENT DOWN. STENTS APPEARED TO BE PROPERLY SIZED ACCORDING TO IVUS ¿ NO SPACE BETWEEN VESSEL WALL AND STENT, NO ¿STEP¿ INTO NATIVE VESSEL WHICH WOULD MEAN AN OVERSIZING. AFTER CLEARING STENTS OF CLOT AND REOPENING, NO COLLATERAL VESSELS APPEARED ON VENOGRAM. THIS LED THE DOCTOR TO BELIEVE THAT THERE ARE NO VESSELS THAT ARE STEALING FLOW FROM THE ILIAC VEINS AFTER THE CASE NO CLINICAL REASON COULD BE CONFIRMED WHY THE STENTS SHUT DOWN AT THAT TIME. PHYSIC

  Patient problems: Obstruction/Occlusion

  MAUDE report 16662534 ↗
• InjurySep 12, 2022Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE AN ABRE VENOUS SELF-EXPANDING STENT DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED VEIN IN THE LEFT DISTAL SUBCLAVIAN VEIN. THE VEIN WAS SEVERELY TORTUOUS. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP OR TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THERE WAS DIFFICULTY REMOVING DEVICE FOLLOWING STENT DEPLOYMENT. THE LESION WAS PRE DILATED WITH AN 8MM DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. PHYSICIAN PRE DILATED STENOSED VEIN WITH AN 8X40 NON-MEDTRONIC BALLOON, AND PROCEEDED TO DEPLOY A 12MMX10MM ABRE STENT IN LEFT SUBCLAVIAN VEIN WITH NO ISSUE. THE MIDDLE PART OF STENT WAS VERY COMPRESSED AND PHYSICIAN NOTICED ONE OF THE STENT STRUTS ABNORMALLY PUSHED INWARD. UPON REMOVING THE ABRE DELIVERY CATHETER, THE NOSE CONE (DISTAL PART OF DELIVERY CATHETER) GOT CAUGHT ON STENT STRUT THAT WAS PUSHING INWARD. PHYSICIAN WAS ABLE TO DISLODGE DELIVERY CATHETER BY PUSHING FORWARD, BUT THEN GOT CAUGHT ON STENT TRYING TO REMOVE AGAIN. PHYSICIAN THEN GAIN F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15405664 ↗
• InjuryDec 15, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  PHYSICIAN WAS ATTEMPTING TO USE THE ABRE SELF EXPANDING STENT TO TREAT MODERATELY CALCIFIED FIBROUS LESION IN THE MID RIGHT COMMON ILIAC VEIN. PATIENT HYDRATED PRIOR TO IMPLANT PROCEDURE. IVUS USED FOR STENT MEASURING AND SIZING. THE VESSEL HAD MODERATE TORTUOSITY. THE ARTERY DIAMETER WAS 18MM AND LESION LENGTH WAS 100MM. 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. THE LESION WAS PRE-DILATED WITH A 20MM PRE-DILATION DEVICE. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE WRONG DIAMETER STENT WAS PLACED INTO PATIENT FROM RIGHT JUGULAR ACCESS, STENT INTENDED TO OVERLAP A PREVIOUSLY DEPLOYED 16MMX80MM ABRE IN THE CF/EXTERNAL ILIAC VEIN. THE 12MMX100MM ABRE STENT WAS DEPLOYED INSIDE THE 16X80 AND WAS FLOATING ON THE WIRE. A 20MMX40MM BALLOON WAS INSERTED TO POST DILATE THE 12X100 STENT, THE STENT WAS STILL FLOATING ON THE WIRE. A 20MMX120MM STENT WAS THEN DEPLOYED INSIDE THE 12X100 AND OVERLAPPING PROXIMAL AND DISTAL INTO COMMON <(>&<)> EXTERNAL VEIN. THE 20MMX120MM STENT TRAPPED THE 12X

  Patient problems: Insufficient Information

  MAUDE report 13008772 ↗

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