Abre™ AB9U10080090Recalls & reported problems
Medtronic, Inc. · STENT AB9U10080090 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169796171), received between Mar 6, 2025 and Mar 6, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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
- Device Markings/Labelling Problem1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2025Device Markings/Labelling Problem; Packaging Problem; Device Markings/Labelling Problem; Packaging Problem
PHYSICIAN WAS ATTEMPTING TO USE ABRE STENT TO TREAT LEFT MID FIBROUS LESION IN COMMON ILIAC VEIN. IT WAS REPORTED THAT THERE WAS A TEAR IN THE PACKAGING. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21534151 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page