Home / Recalls / Medtronic Vascular / Z-1248-2021

Z-1248-2021 Class II Terminated

Recalled by Medtronic Vascular — Danvers, MA

Recall Details

Product Type
Devices
Report Date
March 17, 2021
Initiation Date
January 15, 2021
Termination Date
June 15, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
137 units

Product Description

Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30

Reason for Recall

Sterility may be compromised due to an unsealed pouch

Distribution Pattern

Nationwide

Code Information

Lot Code: 220857555

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  • Z-0290-2022 Class II — Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF252 (October 15, 2021)
  • Z-0291-2022 Class II — Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2 (October 15, 2021)
  • Z-0292-2022 Class II — Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF (October 15, 2021)
  • Z-2135-2021 Class II — Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graf (June 7, 2021)
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  • Z-1860-2021 Class I — Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, (May 4, 2021)
  • Z-1976-2021 Class II — Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For (April 28, 2021)