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Recall Observatory FDA recall evidence

Device product

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

Z-0464-2022

November 19, 2021

Class II

Product summary

Firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Event
Event 89140
Status
Terminated
Classification
Class II
Quantity
21,653 devices
Official record key
device-enforcement:Z-0464-2022

Official wording

Reason: There have been reports of stent migration.

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,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There have been reports of stent migration.