Z-1976-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 7, 2021
- Initiation Date
- April 28, 2021
- Termination Date
- April 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 devices
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.
Distribution Pattern
U.S. Nationwide distribution in the state of GA. O.U.S.: None
Code Information
Model Number: ETBF3216C145E GTIN: 00613994990983 Serial Numbers: V30064787; V30064789; V30064790;