FDAClass IIMay 12, 2021

Medtronic Abre Venous Self-expanding Sent System recall

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

Why was Medtronic Abre Venous Self-expanding Sent System recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI 00643169796348, Lot Number B086915

Product
Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the…
Recalling firm
Medtronic Inc.
Quantity
23 devices
Distribution
US Nationwide distribution in the states of NC, CO, CA, AZ, MT, MO.
Recall date
May 12, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls