Abre™ AB9U16080090Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169796348), received between Apr 6, 2021 and Dec 20, 2022 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 reports).

1 FDA recall record name this device's identifier.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. 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 problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTS AN INFECTION THAT SHE BELIEVED WAS CAUSED BY THE ABRE STENT THAT WAS IMPLANTED. PATIENT REPORTS BACK PAIN, SWEATING, PULSING, FEVER, HIVES, AND URINARY TRACT INFECTION. SHE CONTACTED THE PHYSICIAN REGARDING INFECTION AND WAS TOLD THAT THE SYMPTOMS SHOULD SUBSIDE IN 30 DAYS. SHE SAID THEY DID NOT SUBSIDE AND SHE HAS HAD OFF AND ON INFECTION IN HER PELVIS SINCE THE STENT IMPLANT. THE PATIENT ATTENDED A VASCULAR PHYSICIAN TO GET GUIDANCE. THE PHYSICIAN REPORTS THAT THE PATIENT HAS A METAL ALLERGY THAT THEY DID NOT KNOW ABOUT UNTIL THESE STENTS WERE PLACED AND NEEDS TO HAVE THE STENT REMOVED.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 16012985 ↗
• InjuryNov 21, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  A PHYSICIAN IMPLANTED AN ABRE SELF-EXPANDING STENT FOR THE TREATMENT OF A FIBROUS LESION WITH CHRONIC TOTAL OCCLUSION IN THE DISTAL REGION OF THE SUPERIOR VENA CAVA (SVC). THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THERE WAS MILD TORTUOSITY AND SEVERE CALCIFICATION. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PROCEDURE BEGAN WITH ACCESS THROUGH LEFT SIDED PORT. THEY PASSED A NON-MEDTRONIC WIRE (AMPLATZ) WIRE EASILY THROUGH THE STENOSIS IN THE SVC AFTER PLACING A 9FR SHEATH. THE PHYSICIAN PREDILATED THE ENDS OF THE STENOSIS WITH A NON-MEDTRONIC 16FR (ATLAS) BALLOON, HOWEVER, DIDN'T PREDILATE THE ACTUAL COMPRESSION POINT AS THEY DIDN'T WANT TO PREDILATE THE TIGHT COMPRESSION WITH CONCERNS THE STENT WOULD THEN WATERMELON SEED FORWARD AND WE WOULD LOSE ACCURACY. THEY HAD A 12 AND 16 NON-MEDTRONIC BALLOONS (ATLAS) IN THE ROOM TO POST DILATE AFTER STENT DEPLOYMENT. POST DEPLOYMENT WHEN ATTEMPTING TO WALK THE DELIVERY SYSTEM OFF THE WIRE, DIFFICULTIES REMOVING THE DEVICE WERE ENCOUNTERED AND THE NOSE CONE OF THE STENT WAS STUCK BEYOND THE TIGHT COMPRESSION. THEY UNKNOWINGLY PULLED THE SYSTEM OUT, BUT THE NOSE CONE AND SHAFT WERE LEFT B

  Patient problems: Insufficient Information

  MAUDE report 15834191 ↗
• MalfunctionJun 30, 2021Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  PHYSICIAN USED AN ABRE VENOUS STENT SYSTEM WITH A 9FR SHEATH DURING TREATMENT OF A 60MM FIBROUS CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PROXIMAL LEFT BRACHIOCEPHALIC VEIN. SLIGHT VESSEL TORTUOSITY WAS REPORTED. VESSEL DIAMETER REPORTED AS 12-14MM. EMBOLIC PROTECTION WAS NOT USED. NO DAMAGE WAS 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 AS PER IFU WITHOUT ISSUE. PRE-DILATION WAS PERFORMED USING 10MM AND 12MM BALLOONS. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. THE STENT WAS DEPLOYED WITHOUT ISSUE. POST-DILATION WAS PERFORMED USING A 18MM BALLOON AT LOW PRESSURE. IT IS REPORTED STENT DEFORMATION OCCURRED IN VIVO. POST-IMAGING OF THE STENT PLACEMENT REVEALED DEFORMED STENT STRUTS. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12091501 ↗
• MalfunctionApr 12, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AN ABRE DEVICE WAS IMPLANTED DURING A PATIENT PROCEDURE. THE STRAIN RELIEF ON THE DEVICE WAS LABELLED INCORRECTLY AS 18MM. THE IMPLANTED STENT IS OF LENGTH 16MM MATCHING THE STERILE POUCH PACKAGE LABELLING AND THE OUTER BOX LABELLING. THE DEVICE WAS SUCCESSFULLY DEPLOYED WITHOUT INCIDENT OR ISSUE. THE PHYSICIAN HAD INTENDED TO IMPLANT A 16MM ABRE STENT BASED ON VESSEL MEASUREMENTS TAKE OFF IVUS. THE PROCEDURE WENT AS PLANNED WITHOUT ANY ISSUES. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649772 ↗
• MalfunctionApr 12, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AN ABRE DEVICE WAS IMPLANTED DURING A PATIENT PROCEDURE. THE STRAIN RELIEF ON THE DEVICE WAS LABELLED INCORRECTLY AS 18MM. THE IMPLANTED STENT IS OF LENGTH 16MM MATCHING THE STERILE POUCH PACKAGE LABELING AND THE OUTER BOX LABELING. THE DEVICE WAS SUCCESSFULLY DEPLOYED WITHOUT INCIDENT OR ISSUE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649699 ↗
• MalfunctionApr 6, 2021Nonstandard Device; Nonstandard Device

  PHYSICIAN INTENDED TO USE AN ABRE STENT DURING PATIENT TREATMENT. THERE WAS NO DAMAGE NOTED TO PACKAGING. IT IS REPORTED WHEN OPENING THE PACKAGING FOR AN ABRE STENT LABELLED MODEL AB9U16080090, DEVICE FROM MODEL AB9U18080090 WAS INSIDE THE PACKAGING. THE ISSUE WAS NOTED DURING PREP OF THE DEVICE AND THE DEVICE WAS NOT USED IN PATIENT. ANOTHER STENT WAS OPENED TO COMPLETE PROCEDURE. NO PATIENT INVOLVEMENT REPORTED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11619952 ↗

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.