FDA-Device2022-01-12Class II
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
There have been reports of stent migration.
Sold states
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,
Affected count
21,653 devices
Manufactured in
8200 Coral Sea St Ne, N/A, Mounds View, MN, United States
Products
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0464-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief