Home / Recalls / Medtronic Vascular / Z-3253-2018

Z-3253-2018 Class III Terminated

Recalled by Medtronic Vascular — Danvers, MA

Recall Details

Product Type
Devices
Report Date
October 3, 2018
Initiation Date
August 16, 2018
Termination Date
May 7, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
250 units

Product Description

Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35

Reason for Recall

Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the correct U5TRAN35 item, the outer carton has all the correct labeling, and all the other information and configuration details on both the carton and the pouch are correct.

Distribution Pattern

CA, IA, NE, TN, TX, VA, WA, Jamaica, New Zealand, Thailand

Code Information

UDI/GTIN: 20643169738717 Lot Number 60068186

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