Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
- Company
- Medtronic Vascular, Inc.
- Recall Initiated
- April 28, 2021
- Terminated
- April 5, 2024
- Recall Number
- Z-1976-2021
- Quantity
- 3 devices
- Firm Location
- Santa Rosa, CA
Reason for Recall
Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
Distribution
U.S. Nationwide distribution in the state of GA. O.U.S.: None
Lot / Code Info
Model Number: ETBF3216C145E GTIN: 00613994990983 Serial Numbers: V30064787; V30064789; V30064790;
Root Cause
Process control
Action Taken
Beginning on 04/28/2021, the Recalling Firm initiated a verbal notification and retrieved affected product for a single U.S. customer. On 05/10/2021, the Recalling Firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via UPS 2-day delivery to inform its impacted customer that the Recalling Firm has determined that the stent graft system was manufactured with an incorrect stentstop assembly. The letter was also to to ask for confirmation that the customer no longer had the affected devices in its possession. The letter instructed customers to take the following actions: 1. Complete the enclosed Customer Confirmation Form and email to rs.cfqfca@medtronic.com. 2. Forward this notice to all those who need to be aware within your organization. If there are any questions - contact the Recalling Firm's Field Representative.