AbreRecalls & reported problems across all models

We found 26 models of Abre by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 118 adverse event reports in the FDA's MAUDE database, received between Dec 8, 2020 and Aug 18, 2026 — classified as 3 deaths, 49 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (41 reports).

3 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Abre recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 4 of these models · Recall details · FDA record ↗

2. Feb 16, 2024Open, Classified

   There is a potential for sterile package breach.

   Z-1317-2024 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

3. Mar 16, 2021Terminated

   Incorrect size printed on the device; packaging is labeled correctly.

   Z-1532-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported Abre problems

Abre models

26 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Abre™ AB9U14080090

  Stent, iliac vein
  2 recalls9 reports
• Abre™ AB9U16080090

  Stent, iliac vein
  1 recall6 reports
• Abre™ AB9U12060090

  Stent, iliac vein
  1 recall4 reports
• Abre™ AB9U14060090

  Stent, iliac vein
  1 recall4 reports
• Abre™ AB9U14100090

  Stent, iliac vein
  1 recall4 reports
• Abre™ AB9U18100090

  Stent, iliac vein
  1 recall2 reports
• Abre™ AB9U16150090

  Stent, iliac vein
  15 reports
• Abre™ AB9U14150090

  Stent, iliac vein
  10 reports
• Abre™ AB9U14120090

  Stent, iliac vein
  8 reports
• Abre™ AB9U16100090

  Stent, iliac vein
  7 reports
• Abre™ AB9U16120090

  Stent, iliac vein
  7 reports
• Abre™ AB9U12100090

  Stent, iliac vein
  5 reports
• Abre™ AB9U16060090

  Stent, iliac vein
  5 reports
• Abre™ AB9U18060090

  Stent, iliac vein
  1 death5 reports
• Abre™ AB9U18120090

  Stent, iliac vein
  5 reports
• Abre™ AB9U12120090

  Stent, iliac vein
  4 reports
• Abre™ AB9U20080090

  Stent, iliac vein
  1 death4 reports
• Abre™ AB9U18080090

  Stent, iliac vein
  3 reports
• Abre™ AB9U18150090

  Stent, iliac vein
  2 reports
• Abre™ AB9U20060090

  Stent, iliac vein
  1 death2 reports
• Abre™ AB9U20150090

  Stent, iliac vein
  2 reports
• Abre™ AB9U10040090

  Stent, iliac vein
  1 report
• Abre™ AB9U10060090

  Stent, iliac vein
  1 report
• Abre™ AB9U10080090

  Stent, iliac vein
  1 report
• Abre™ AB9U20100090

  Stent, iliac vein
  1 report
• Abre™ AB9U20120090

  Stent, iliac vein
  1 report

Recent Abre adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Activation, Positioning or Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50300095 ↗
• InjuryAug 14, 2026Fracture; Material Deformation

  It was reported that during deployment of an ABRE stent for treatment of non-thrombotic compression in the proximal left common iliac vein, the stent was found to be broken around the top ring of struts. The target was a 10 mm soft-tissue lesion in a 13 mm vessel with minimal tortuosity. The vessel was pre-dilated, no embolic protection was used, and the instructions for use were followed without issue. Stent deformation was reported, with the stent/struts described as deformed before use. The stent could not be retrieved and was fully deployed. Stent correction was needed, and a second Medtronic stent was deployed in the contralateral vein to hold the affected stent in place and prevent embolization. The patient was alive with no further injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254670 ↗
• 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 ↗
• 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 ↗
• 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 50207127 ↗
• MalfunctionAug 6, 2026Fracture; Activation, Positioning or Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50153817 ↗
• MalfunctionAug 5, 2026Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50139170 ↗
• MalfunctionMay 25, 2026Premature Activation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING AN ABRE STENT, A DEPLOYMENT ISSUE OCCURRED, PRE-DEPLOYMENT WHILE THE DEVICE WAS ON THE WAY TO THE TARGET SITE. THE SURGERY WAS DELAYED FOR 5 MINUTES DUE TO THE PRODUCT ISSUE. THE STENT DID NOT REMAIN IN THE PATIENT AND WAS REMOVED SUCCESSFULLY IN TANDEM WITH THE DELIVERY SYSTEM WITHOUT INJURY OR INTERVENTION. NO VESSEL DAMAGE WAS REPORTED. THE PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC 16X150 ABRE DEVICE. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25268703 ↗
• 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 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  ABSTRACT ESSENTIALLY ALL ENDOVASCULAR STENTS, BOTH STAINLESS STEEL AND NITINOL, CONTAIN A NICKEL COMPONENT. INCIDENCE OF NICKEL HYPE RSENSITIVITY IS COMMON, BUT NICKEL HYPERSENSITIVITY DOES NOT ALWAYS RESULT IN CLINICALLY SIGNIFICANT REACTIONS. THIS 43- YEAR-OLD WOMAN PRESENTED WITH HIVES, URTICARIA, AND MALAISE AFTER NITINOL STENT PLACEMENT IN HER LEFT ILIAC VEIN FOR MAYTHURNER SYNDROME. SHE UNDERWENT OPEN STENT EXPLANATION AND RECONSTRUCTION OF HER INFERIOR VENA CAVA AND LEFT COMMON ILIAC VEIN WITH SUBSEQUENT RESOLUTION OF SYMPTOMS. THE LOW INCIDENCE OF STENT-RELATED ALLERGY DOES NOT WARRANT PREOPERATIVE TESTING, BUT WE ADVOCATE FOR THOROUGH PREPROCEDURAL DISCUSSION IN HIGH-RISK PATIENTS. FOR SYMPTOMATIC PATIENTS, EXPLANATION CAN BE EFFECTIVE. THE PATIENT IS A 43-YEAR-OLD WOMAN WITH A HISTORY OF LEFT LOWER EXTREMITY VENOUS INSUFFICIENCY AND DEEP VENOUS THROMBOSIS (DVT) SECONDARY TO ORAL CONTRACEPTIVE USE. SHE RECEIVED A NITINOL CONTAINING ABRE (MEDTRONIC) LEFT ILIAC VEIN STENT FOR PRESUMED MAY-THURNER SYNDROME AT AN OUTSIDE FACILITY. IMMEDIATELY AFTER IMPLANTATION, SHE DEVELOPED MULTIFOCAL FACIAL EDEMA, HIVES, AND URTICARIA. SHE WAS SEEN BY AN ALLERGIST WHO DIAGNOSED HER WITH A N

  Patient problems: Local Reaction; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 24751909 ↗
• InjuryJan 29, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT A PHYSICIAN PLACED A 14X100MM ABRE STENT TO TREAT A RIGHT COMMON ILIAC VEIN STENOSIS AS PART OF A PULMONARY EMBOLISM THROMBECTOMY AND THE STENT MIGRATED THE FOLLOWING MORNING. MINIMAL VESSEL TORTUOSITY WAS REPORTED. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS POST-DILATED. THE PATIENT CLINICAL PRESENTATION AT THE TIME OF IMPLANT WAS PULMONARY EMBOLISM (PE). THE LESION LOCATION AND LOCATION OF STENT PLACEMENT WAS THE EXTERNAL ILIAC VEIN (EIV). THE PATIENT WAS HYDRATED PRIOR TO PROCEDURE. AN ANGIOGRAM WAS USED FOR IMAGING, AND THE DEGREE OF STENOSIS WAS >50%. THE STENT DID NOT LAND IN A CURVE. THE STENT WAS CONFIRMED TO HAVE PROPER PLACEMENT FOLLOWING DEPLOYMENT. THE STENT MIGRATED TO THE HEART. THE STENT WAS EXPLANTED FROM THE HEART, ILAC LEFT ALONE. THE PATIENT REQUIRED PROLONGATION OF EXISTING HOSPITALIZATION.

  Patient problems: Insufficient Information

  MAUDE report 24209646 ↗
• 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 ↗
• InjuryJan 23, 2026Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT TREATMENT FOR A LESION IN THE LEFT MID AND DISTAL COMMON AND EXTERNAL ILIAC VEIN USING A 12X120MM ABRE STENT. THE LESION EXHIBITED 90% STENOSIS OVER AN 80MM LENGTH, WITH A VESSEL DIAMETER OF APPROXIMATELY 10MM. MINIMAL VESSEL TORTUOSITY AND MINIMAL VESSEL CALCIFICATION WAS REPORTED. THERE WERE ABNORMALITIES IN RELATION TO ANATOMY, WITH TUMOR COMPRESSION OF LEFT COMMON AND EXTERNAL ILIAC VEIN REPORTED. A 10FR NON-MEDTRONIC SHEATH WAS USED. THE VESSEL WAS PRE-DILATED WITH A 12X40MM NON-MEDTRONIC PTA DILATATION CATHETER. PHYSICIAN CROSSED LESION EASILY DESPITE COMPRESSION. THE ABRE STENT WAS PLACED ACROSS LESION WITHOUT DELIVERY ISSUES. AFTER PLACEMENT, SEVERE COMPRESSION AND DEFORMATION OF THE DISTAL SEGMENT OF THE STENT WERE OBSERVED, INCLUDING PANCAKING AND INCOMPLETE OPENING, AS CONFIRMED BY INTRAVASCULAR ULTRASOUND AND VENOGRAPHY, WHICH ALSO SHOWED DELAYED CONTRAST WASHOUT INDICATING FLOW-LIMITING COMPRESSION. THE VESSEL WAS POST-DILATED WITH 12X40MM NON-MEDTRONIC PTA DILATATION CATHETER, THEN JUST THE DISTAL PORTION OF STENT WAS POST DILATED WITH A 14X40 NON-MEDTRONIC PTA DILATATION CATHETER, BUT SEVERE COMPRESSION PERSISTED. THE COMPRESS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161304 ↗
• MalfunctionJan 22, 2026Use of Device Problem

  IT WAS REPORTED THAT AN ABRE STENT THAT EXPIRED ON 04-JAN-2026 WAS IMPLANTED IN A PATIENT ON (B)(6) 2026. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24143527 ↗
• 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 ↗

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