Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Reported: July 7, 2021 Initiated: April 28, 2021 #Z-1976-2021
Product Description
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Reason for Recall
Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
Details
- Recalling Firm
- Medtronic Vascular, Inc.
- Units Affected
- 3 devices
- Distribution
- U.S. Nationwide distribution in the state of GA. O.U.S.: None
- Location
- Santa Rosa, CA
Frequently Asked Questions
What product was recalled? ▼
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.. Recalled by Medtronic Vascular, Inc.. Units affected: 3 devices.
Why was this product recalled? ▼
Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 7, 2021. Severity: Moderate. Recall number: Z-1976-2021.
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