Medtronic Inc.: Medical Device Recall in 2021 - (Recall #: Z-1532-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Medtronic 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 outflow obstruction.

Product Classification:

Class II

Date Initiated: March 16, 2021

Date Posted: May 12, 2021

Recall Number: Z-1532-2021

Event ID: 87638

Reason for Recall:

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

Status: Terminated

Product Quantity: 23 devices

Code Information:

UDI 00643169796348, Lot Number B086915

Distribution Pattern:

US Nationwide distribution in the states of NC, CO, CA, AZ, MT, MO.

Voluntary or Mandated:

Voluntary: Firm initiated