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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 89140

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

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 89140 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0464-2022
Event ID89140
Event DescriptionInstructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Product TypeDevices
DistributionDistribution 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,
Quantity21,653 devices
Recall ReasonThere have been reports of stent migration.
Device Classification20220112
Device Code InfoThe IFU for all model numbers and serial numbers.
Center Classification Date20220106
Recall Initiation Date20211119
Recalling FirmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Initial Notification Letter
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