Medtronic Vascular, Inc. Recall 88028
Description: Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Medtronic Vascular, Inc. Recall 88028 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1976-2021 |
| Event ID | 88028 |
| Event Description | Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms. |
| Product Type | Devices |
| Distribution | U.S. Nationwide distribution in the state of GA. O.U.S.: None |
| Quantity | 3 devices |
| Recall Reason | Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr. |
| Device Classification | 20210707 |
| Device Code Info | Model Number: ETBF3216C145E GTIN: 00613994990983 Serial Numbers: V30064787; V30064789; V30064790; |
| Center Classification Date | 20210628 |
| Recall Initiation Date | 20210428 |
| Recalling Firm | Medtronic Vascular, Inc. |
| Initial Notification | Letter |
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