Medtronic Inc. Recall 87638
Description: Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
Medtronic Inc. Recall 87638 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1532-2021 |
| Event ID | 87638 |
| Event Description | Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of NC, CO, CA, AZ, MT, MO. |
| Quantity | 23 devices |
| Recall Reason | Incorrect size printed on the device; packaging is labeled correctly. |
| Device Classification | 20210512 |
| Device Code Info | UDI 00643169796348, Lot Number B086915 |
| Center Classification Date | 20210505 |
| Recall Initiation Date | 20210316 |
| Recalling Firm | Medtronic Inc. |
| Initial Notification | Telephone |
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