Home / Recalls / Medtronic Vascular / Z-1247-2021

Z-1247-2021 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
10 Units

Product Description

Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375

Reason for Recall

Sterility may be compromised due to an unsealed pouch

Distribution Pattern

Nationwide

Code Information

Lot Code: 220772561, 220772562

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  • Z-0292-2022 Class II — Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF (October 15, 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)