Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Recall in 2022 - (Recall #: Z-0464-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.

Product Classification:

Class II

Date Initiated: November 19, 2021

Date Posted: January 12, 2022

Recall Number: Z-0464-2022

Event ID: 89140

Reason for Recall:

There have been reports of stent migration.

Status: Terminated

Product Quantity: 21,653 devices

Code Information:

The IFU for all model numbers and serial numbers.

Distribution Pattern:

Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Argentina, Australia, Austria, Bahrain, Belgium, Botswana, Bulgaria, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Jordan, Kenya, Lithuania, Malaysia, Republic of Moldova, Netherlands, New Zealand, Nicaragua, Norway, Oman, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, and Viet Nam,

Voluntary or Mandated:

Voluntary: Firm initiated