FDA Medical Device Recalls (openFDA)
Medtronic Vascular, Inc.: Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
- Recall number
- Z-1976-2021
- Recalling firm
- Medtronic Vascular, Inc.
- Product
- Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
- Status
- Terminated
- Initiated
- 2021-04-28
- Posted
- not on file
- Terminated
- 2024-04-05
- Reason
- Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
- Root cause
- 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
- 3 devices
- Distribution
- U.S. Nationwide distribution in the state of GA. O.U.S.: None
- Lot, serial or model codes
- Model Number: ETBF3216C145E GTIN: 00613994990983 Serial Numbers: V30064787; V30064789; V30064790;
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MIH
- Firm FEI
- 3005364322
- Firm city
- Santa Rosa
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28