Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.

Recalled January 12, 2022 · FDA recall Z-0464-2022 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Hazard

There have been reports of stent migration. · FDA Class II

Units

21,653 devices

Sold at

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,

Description

There have been reports of stent migration.

Product

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

Manufacturer(s)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →