Abre™ AB9U16060090Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169796331), received between Feb 23, 2021 and Aug 6, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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.

• MalfunctionAug 6, 2026Fracture; Activation, Positioning or Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50153817 ↗
• MalfunctionJun 22, 2022Fracture; Fracture

  LIMITED INFORMATION REPORTED THAT PHYSICIAN IMPLANTED 3 NON-MEDTRONIC VENOUS STENT (VICI): ONE IN THE IN THE LEFT ILIAC 16X120X100 AND 2 IN THE EXTERNAL RIGHT ILIAC, 16X90X100 IN 2020. ONE YEAR LATER THE LEFT STENT WAS OCCLUDED, VENOGRAM, LYSIS CATHETER, THROMBECTOMY. ABRE SELF-EXPANDING BARE METAL STENT LEFT STENT FRACTURE ¿ VENOGRAM LEFT. NO FURTHER INFORMATION AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14769480 ↗
• MalfunctionApr 29, 2022Premature Activation; Premature Activation

  PHYSICIAN USED AN ABRE SELF-EXPANDING STENT DURING TREATMENT OF A LESION IN THE PATIENT'S LEFT COMMON 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 AS PER IFU WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT.. DEPLOYMENT ISSUES ARE REPORTED. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE AND REMOVED PRIOR TO DEPLOYMENT OF THE STENT. THE STENT WAS ATTEMPTED TO REPOSITION PULLING STENT BACK SLIGHTLY AND IT DEPLOYED ON ITS OWN. THERE WAS NO ATTEMPTS MADE TO REMOVE THE STENT. THERE WAS NO DEFORMATION NOTED TO THE DEPLOYED STENT. THE DELIVERY SYSTEM WAS SAFELY REMOVED. THERE WAS NO VESSEL DAMAGE NOTED. A SECOND STENT WAS PLACED TO EXTEND FROM THE FIRST ONE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14247871 ↗
• MalfunctionApr 28, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A ABRE SELF-EXPANDING STENT DEVICE TO TREAT A LESION IN THE LEFT DISTAL COMMON ILIAC VEIN IN A PATIENT. IFU WAS FOLLOWED WITH NO ISSUES NOTED. IT WAS REPORTED THAT DEPLOYMENT DIFFICULTIES OCCURRED ¿ THE PHYSICIAN DEPLOYED STENT PARTIALLY WITH INTENT TO REPOSITION. UPON ATTEMPTING TO REPOSITION, STENT LOCKED INTO PLACE IN VESSEL AND AS PHYSICIAN PULLED BACK, STENT WAS DEPLOYED IN VESSEL WITHOUT USING THUMBWHEEL TO RELEASE STENT. THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE LOCK-PIN REMOVED PRIOR TO STENT DELIVERY. THE LESION WAS NOT PREDILATED, DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED, AND NO EXCESSIVE FORCE WAS USED. THE PROCEDURE WAS COMPLETED BY PULLING BACK THE DELIVERY CATHETER AND THE STENT CAME OUT OF DEVICE INTO VESSEL WITHOUT USING THUMBWHEEL FOR DELIVERY. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11738177 ↗
• InjuryFeb 23, 2021Material Deformation; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE THE ABRE VENOUS SELF-EXPANDING STENT DURING PROCEDURE TO TREAT A NONE CALCIFIED PLAQUE LESION IN THE LEFT PROXIMAL COMMON ILIAC VEIN (CIV) . THE VESSEL DIAMETER AND LESION LENGTH ARE 14MMAND 50MM RESPECTIVELY. NO EMBOLIC PROTECTION WAS 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. IMPROPER DEPLOYMENT ISSUE OCCURRED. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE LOCK-PIN WAS REMOVED PRIOR TO DEPLOYMENT WITH STENT ACROSS THE LESION. THE VESSEL WAS NOT PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE WITH NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT THE STENT WAS FULLY DEPLOYED AFTER INFLATION WITH A 10X40 NON-MEDTRONIC BALLOON. THE STENT WAS SLI GHTLY BELOW TARGET BUT FULLY APPOSED TO VESSEL WALL VIA IVUS. PATIENT HAD VARIOUS LEVELS OF DISEASE FROM SUPERFICIAL THROUGH AND INTO THE CIV. POPLITEAL ACCESS. NO PRE DIL OF ANY ZONE BEFORE STENTING THE COMMON ILIAC. THERE WERE ISSUES ADVANCING THE STENT THROUGH THE SUPERFICIA

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11366349 ↗

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