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 00643169796348Lot 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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