Medtronic Vascular, Inc. Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Brand
Medtronic Vascular, Inc.
Lot Codes / Batch Numbers
Model Number: ETBF3216C145E GTIN: 00613994990983 Serial Numbers: V30064787, V30064789, V30064790
Products Sold
Model Number: ETBF3216C145E GTIN: 00613994990983 Serial Numbers: V30064787; V30064789; V30064790;
Medtronic Vascular, Inc. is recalling Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascul due to Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026