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Recall Observatory FDA recall evidence

Device product

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

Z-3253-2018

August 16, 2018

Class III

Product summary

Firm
Medtronic Vascular
Event
Event 80919
Status
Terminated
Classification
Class III
Quantity
250 units
Official record key
device-enforcement:Z-3253-2018

Official wording

Reason: 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.

Code information: UDI/GTIN: 20643169738717 Lot Number 60068186

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.