Reported Mar 27, 2024 · Ongoing

Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090

Medtronic Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medtronic Inc. · 4600 Nathan Ln N · Plymouth, MN · 55442-2890

Is this the product you have?

  • Abre Venous Self-expanding Stent System
  • Product Numbers
    • a) AB9U14080090
    • b) AB9U18100090
    • c) AB9G14100090
Lot codes and dates
    • a) AB9U14080090
    • UDI/DI 00643169796294
    • Batch Number B456626
    • b) AB9U18100090
    • UDI/DI 00643169796409
    • Batch Number B456811
    • c) AB9G14100090
    • IUDI/DI 00763000547325
    • Batch Number B460542
Amount recalled
65 units

Where it was sold

  • Nationwide

Why it was recalled

There is a potential for sterile package breach.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:58 PM UTC

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