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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0464-2022 |
| Event ID | 89140 |
| Event Description | Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System. |
| Product Type | 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, |
| Quantity | 21,653 devices |
| Recall Reason | There have been reports of stent migration. |
| Device Classification | 20220112 |
| Device Code Info | The IFU for all model numbers and serial numbers. |
| Center Classification Date | 20220106 |
| Recall Initiation Date | 20211119 |
| Recalling Firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Initial Notification | Letter |
| Similar To |