Recall Z-1976-2021— Medtronic Vascular, Inc.

Name: FDA recall Z-1976-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-28

Class II · Terminated

Class II FDA medical device recall by Medtronic Vascular, Inc., initiated 2021-04-28, terminated 2024-04-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.. Reason: Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr..

Recalling firm: Medtronic Vascular, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-04-28
Terminated: 2024-04-05
Firm location: Santa Rosa, CA, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.