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U.S. Department of Health and Human Services

Class 2 Device Recall Endurant II/IIs Stent Graft System

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  Class 2 Device Recall Endurant II/IIs Stent Graft System see related information
Date Initiated by Firm April 28, 2021
Create Date June 28, 2021
Recall Status1 Terminated 3 on April 05, 2024
Recall Number Z-1976-2021
Recall Event ID 88028
Product Classification System, endovascular graft, aortic aneurysm treatment - Product Code MIH
Product Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Code Information Model Number: ETBF3216C145E GTIN: 00613994990983 Serial Numbers: V30064787; V30064789; V30064790; 
Recalling Firm/
Manufacturer		 Medtronic Vascular, Inc.
3850 Brickway Blvd
Santa Rosa CA 95403-8223
Manufacturer Reason
for Recall		 Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 3 devices
Distribution U.S. Nationwide distribution in the state of GA. O.U.S.: None
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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