Reported May 12, 2021 · Terminated

Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in…

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?

  • Medtronic Abre Venous Self-expanding Sent System, Catalog
  • number REF AB9U16080090 - Product Usageintended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction
Lot codes and dates
    • UDI 00643169796348
    • Lot Number B086915
Amount recalled
23 devices

Where it was sold

Why it was recalled

Incorrect size printed on the device; packaging is labeled correctly.

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

Notice updated Apr 15, 2024 · Data as of Sep 19, 6:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.