Home / Recalls / Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) / Z-0464-2022

Z-0464-2022 Class II Terminated

Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Mounds View, MN

FDA device recall Z-0464-2022 was initiated by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) on November 19, 2021 and is designated Class II. Reason for recall: There have been reports of stent migration. The recall status is terminated (terminated August 16, 2024). Affected quantity: 21,653 devices.

Recall Details

Product Type: Devices
Report Date: January 12, 2022
Initiation Date: November 19, 2021
Termination Date: August 16, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 21,653 devices

Product Description

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

Reason for Recall

There have been reports of stent migration.

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,

Code Information

The IFU for all model numbers and serial numbers.

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