Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
FDA Recall #Z-0464-2022 — Class II — November 19, 2021
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.
Recalling Firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Mounds View, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
21,653 devices
Distribution
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.