Abre™ AB9U14080090Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169796294), received between Oct 13, 2021 and Aug 11, 2026 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 4, 2025Open, Classified

   Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.

   Z-1098-2026 · Root cause: Under Investigation by firm · FDA record ↗

2. Feb 16, 2024Open, Classified

   There is a potential for sterile package breach.

   Z-1317-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 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 50207174 ↗
• MalfunctionApr 7, 2026Material Deformation

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE USING THE ABRE STENT IN THE RIGHT PROXIMAL COMMON ILIAC PERIPHERAL VEIN, THE THUMBWHEEL MALFUNCTIONED MID-DEPLOYMENT. THE HANDLE WAS SEPARATED TO COMPLETE DEPLOYMENT, AND THE STENT WAS DEPLOYED WITHOUT DIFFICULTY. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED BARD VENOVO STENT. THE TARGET LESION WAS DESCRIBED AS FIBROUS, AND THE VESSEL DIAMETER WAS REPORTED AS 12 MM. THE VESSEL WAS PRE-DILATED AND POST-DILATED, AND POST-DILATION WAS PERFORMED WITH A BARD ATLAS BALLOON; THE STENT WAS POST-DILATED AND OPTIMIZED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, PACKAGING AND DEVICE REMOVAL FROM THE TRAY WERE REPORTED WITHOUT ISSUES, AND THE INSTRUCTIONS FOR USE WERE REPORTED AS FOLLOWED WITH THE NOTED THUMBWHEEL ISSUE. THE PATIENT WAS REPORTED ALIVE WITH NO HEALTH CONSEQUENCES OR IMPACT AND WAS DISCHARGED THE NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24797357 ↗
• MalfunctionJan 27, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A NONTHROMBOTIC ILIAC VEIN LESION (NIVL), A FIBROUS LESION WITH 65% STENOSIS, 200MM LENGTH, AND 16MM DIAMETER WAS IDENTIFIED IN THE MID LEFT COMMON ILIAC VEIN. VESSEL PRE-DILATION AND POST-DILATION WERE PERFORMED USING A 16MM X 40MM NON MEDTRONIC BALLOON. A 9FR NON MEDTRONIC SHEATH AND 0.35 GUIDEWIRE WERE USED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED ABRE STENT. THE LOCK-PIN WAS REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. WHEN ATTEMPTING TO DEPLOY THE STENT AB9U14080090 ABRE, A DEPLOYMENT ISSUE OCCURRED AND THE STENT COULD NOT BE DEPLOYED. UPON REMOVAL, STENT STRUTS WERE EXPOSED AND VISIBLE. NO INTERVENTION WAS REQUIRED FOR REMOVAL OF THE DEVICE. THE DEVICE WAS NEVER IMPLANTED, 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 24187117 ↗
• InjuryJun 5, 2025Premature Activation; Detachment of Device or Device Component; Premature Activation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE ABRE SELF EXPANDING STENT ALONG WITH A 9FR NON-MEDTRONIC SHEATH, THE DEVICE WAS DEPLOYED IN THE LEFT DISTAL COMMON ILIAC VEIN (PERIPHERAL VEIN). THE ABRE STENT WAS PUT THROUGH 9FR SHEATH AND STENT WAS ALREADY DEPLOYING EVEN WITH SAFETY PIN IN PLACE. THE STENT DETACHED IN VIVO AND REQUIRED A SURGICAL CUT-DOWN INTERVENTION TO REMOVE THE DETACHED STENT. THE PATIENT'S COMMON FEMORAL VEIN TORE AFTER STENT DEPLOYED AND WAS REMOVED. THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND THE PROCEDURE WAS ABORTED. THE DEVICE WAS EXPLANTED.

  Patient problems: Perforation of Vessels

  MAUDE report 22150582 ↗
• InjuryMay 23, 2023Migration or Expulsion of Device; Difficult to Remove; Activation, Positioning or Separation Problem; Migration or Expulsion of Device; Difficult to Remove; Activation, Positioning or Separation Problem

  A PHYSICIAN WAS USING AN ABRE SELF-EXPANDING STENT FOR THE TREATMENT OF A 50MM LESION WITH 75% STENOSIS IN THE PROXIMAL REGION OF THE LEFT COMMON ILIAC VEIN. THE ARTERY DIAMETER WAS 12MM WITH MILD TORTUOSITY AND NO CALCIFICATION. A 9FR NON MEDTRONIC SHEATH AND A 0.035 STIFF GLIDEWIRE WAS USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS NOT PRE-DILATED. THERE WAS NO RESISTANCE DURING ADVANCEMENT AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE PATIENT¿S CLINICAL PRESENTATION AT THE TIME OF IMPLANT WAS NIVL. IT WAS REPORTED THE PHYSICIAN USED IVUS TO ENSURE THE CORRECT SIZED STENT WAS USED. THE HEALTHY LEFT COMMON ILIAC VEIN WAS MEASURING 12MM ON IVUS SO THE PHYSICIAN DECIDED TO USE A 14MM X 80MM ABRE STENT BASED ON THE ABRE IFU. THE STENT PLACEMENT LOCATION WAS THE LEFT COMMON ILIAC VEIN. PHYSICIAN MENTIONED THAT THE THUMBWHEEL STUCK A LITTLE BIT AT THE START OF DEPLOYMENT, BUT THEN IT WORKED FINE AFTER 2 CLICKS OF THE THUMBWHEEL AND THE STENT DEPLOYED WITH NO ISSUES. IT WAS ALSO MENTIONED THAT THE INNER SHAFT OF THE DELIVERY CATHETER "STUCK" TO THE STENT DURING REMOVAL OF THE DELIVERY CATHETER. AFTER A MINUTE OR T WO, THE DEL

  Patient problems: Chest Pain; Dyspnea

  MAUDE report 16982765 ↗
• InjuryOct 7, 2022Fracture; Fracture

  A PHYSICIAN USED AN ABRE STENT TO TREAT A CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE RIGHT PROXIMAL SVC OF A PATIENT. NO TORTUOSITY OR CALCIFICATION. 12MM ARTERY DIAMETER. 9FR TERUMO SHEATH AND 260 AMPLATZ GUIDEWIRE WERE USED. IT IS REPORTED THAT THERE WAS DAMAGE NOTED TO PACKAGING AND THERE WERE ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY, THERE WAS A SMALL CREASE ON THE BLUE SHEATH. THE REP TOLD THE PHYSICIAN THAT THEY DIDN'T WANT TO USE THE STENT, BUT THE DAMAGE WAS IN THE MIDDLE OF THE BOX, NOT WHERE THE STENT WAS AND HE DECIDED HE WANTED TO STILL USE IT. THE DEVICE PREPPED PER THE IFU, WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED WITH A 6 BALLOON AND THEN A 10 BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE USED. AFTER POST DILATION OF THE 14 STENT WITH A 12 BALLOON, THE PATIENT WAS BLEEDING INTERNALLY. THE TEAM RUSHED IN AND PUT UP A BALLOON FOR 15 MINS TO STOP THE BLEEDING. THEN A CHEST TUBE WAS PLACED AND ABOUT 2 LITERS OF BLOOD WERE REMOVED. SAID HE WISHED HE WOULD HAVE USED A 10 BALLOON TO POST DILATE INSTEAD OF A 12 AND THAT HE BELIEVES THE STENT FRACTURED A

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 15563318 ↗
• MalfunctionJul 26, 2022Device Damaged by Another Device; Device Damaged by Another Device

  PHYSICIAN WAS ATTEMPTING TO USE AN ABRE SELF-EXPANDING STENT DURING THE PROCEDURE ALONG WITH NON-MEDTRONIC 9FR SHEATH, 0.035" GUIDEWIRE AND AN IVC FILTER IN PLACE FOR EMBOLIC PROTECTION DURING PROCEDURE. THEE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. BALLOON INFLATION DIFFICULTIES WAS REPORTED WITH DEVICE SLOW TO DEFLATE AT THE LESION SITE, THE BALLOON WAS A IT WAS AN ATLAS 14X40 FROM BARD. DEFLATION ISSUE NOTED DURING SUBSEQUENT INFLATION AND IT WAS BALLOONED AGAIN. THE LESION WAS PRE DILATED WITH A 14X40 DEVICE. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE NEW TECH FELT A LOT OF RESISTANCE WHEN TRYING TO DEFLATE THE BALLOON. BALLOON WAS REMOVED AND A PIECE OF POTENTIAL STENT WAS ATTACHED TO BALLOON. GOT A NEW BALLOON AND POST DILATED AGAIN. NO VESSEL DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15101226 ↗
• InjuryMar 21, 2022Compatibility Problem; Material Deformation; Compatibility Problem; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE AN ABRE SELF-EXPANDING STENT ALONG WITH NON-MEDTRONIC 9FR AND 0.035" GLIDEWIRE DURING PROCEDURE TO TREAT A NONE CALCIFIED SOFT TISSUE IN THE RIGHT PROXIMAL INOMINATE BRACHIOCEPHALIC VEIN. THE VESSEL WAS SEVERELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH WERE 12MM AND 6MM RESPECTIVELY. 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. THE LESION WAS PRE DILATED WITH A 12X40 DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING WITHDRAWAL. IT WAS REPORTED THAT A NON-MEDTRONIC 14MM X 40MM BALLOON WAS USED FOR POST DILATATION OF DEPLOYED 14 X 80 ABRE STENT. NO ISSUES WHATSOEVER WITH ABRE DEPLOYED PERFECTLY. ISSUE WAS WITH THE POST DILATATION BALLOONS. PHYSICIAN WAS NOT USING AN ENDOFLATER, USED A SYRINGE AND TAKE DOWN BALLOON. BALLOON GOT HUNG UP ON STRUTS AND PHYSICIAN HAD TO TWIST AND TUG ON PTA CATHETER TO DISLODGE. PHYSICIAN STATED NO ISSUE WITH STENT - JUST WITH THE BALLOON GETTING HUNG UP ON STRUTS. PHYSICIAN DEPLOYED A 12

  Patient problems: Insufficient Information

  MAUDE report 13838108 ↗
• InjuryOct 13, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING INDEX PROCEDURE, PHYSICIAN IMPLANTED ABRE SELF-EXPANDING STENT DURING PROCEDURE IN A NONE CALCIFIED FIBROUS LESION IN THE PROXIMAL COMMON ILIAC VEIN WITH 70% STENOSIS. DURING PROCEDURE, 6FR SHEATH AND NON-MEDTRONIC 0.035" GUIDEWIRE WERE USED. THE VESSEL WAS NONE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 12.5MM AND 70MM RESPECTIVELY. NO EMBOLIC PROTECTION WAS NOT 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. THE LESION WAS NOT PRE DILATED. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PATIENT WAS HYDRATED PRIOR TO THE IMPLANT PROCEDURE AND THE PHYSICIAN ALWAYS HYDRATES THE VENOUS CASES BEFORE PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN USED IVUS TO MEASURE THE VEIN. THE MEASUREMENT WAS 12.5MM; THEREFORE, THE PHYSICIAN CHOSE TO PUT IN A 14MM STENT. THE PHYSICIAN USED IVUS AND FLUORO TO VERIFY STENT PLACEMENT AND APPOSITION AFTER DEPLOYMENT. APPROXIMATELY 2 MONTHS POST PROCEDURE, THE PATIENT PRESENTED TO THE CLINIC WITH VAGUE CHEST PAIN. THE PHYSICIAN PERFORMED AN ECHO AT THE OFFICE AND THE ULTRASOUND TECHNICIAN SAW THE STE

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12623057 ↗

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-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