Abre™ AB9U10040090Recalls & reported problems
Medtronic, Inc. · STENT AB9U10040090 ABRE V01 · Class 3 · Implant
All models of Abre (26)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169796157), received between Jun 4, 2024 and Jun 4, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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.
Reports received per month
Most reported problems
Device problems
- Migration or Expulsion of Device1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 4, 2024Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT AN ABRE VENOUS STENT WAS PLACED TO THE LEFT RENAL VEIN ACCORDING TO THE INSTRUCTIONS FOR USE. LATER THAT DAY, THE STENT WAS NOTED TO HAVE MIGRATED TO THE RIGHT ATRIUM. ATTEMPTS AT ENDOVASCULAR RETRIEVAL WAS NOT SUCCESSFUL AND PATIENT REQUIRED STERNOTOMY AND CARDIOPULMONARY BYPASS TO REMOVE THE STENT.
Patient problems: Insufficient Information
MAUDE report 19462788 ↗
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, ClassifiedAbre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G1410
- Z-0464-2022 · Nov 19, 2021 · TerminatedInstructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
- Z-1532-2021 · Mar 16, 2021 · TerminatedMedtronic 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
Other Stent, iliac vein devices
- Abre™ AB9U14080090Medtronic, Inc. · Stent, iliac vein2 recalls9 reports
- Venovo® VENUM16100Angiomed GmbH & Co. Medizintechnik KG · Stent, iliac vein1 recall55 reports
- Venovo® VENUM14080Angiomed GmbH & Co. Medizintechnik KG · Stent, iliac vein1 recall36 reports
- Venovo® VENUM14120Angiomed GmbH & Co. Medizintechnik KG · Stent, iliac vein1 recall33 reports
- Venovo® VENUM14140Angiomed GmbH & Co. Medizintechnik KG · Stent, iliac vein1 recall31 reports
- Venovo® VENUM14100Angiomed GmbH & Co. Medizintechnik KG · Stent, iliac vein1 recall30 reports
- Venovo® VENUM16120Angiomed GmbH & Co. Medizintechnik KG · Stent, iliac vein1 recall29 reports
- Venovo® VENUM14160Angiomed GmbH & Co. Medizintechnik KG · Stent, iliac vein1 recall27 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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