FDA recall Z-3253-2018

Product

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

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

Key facts

Status

Terminated

Initiation date

2018-08-16

Report date

2018-10-03

Termination date

2021-05-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Danvers, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3253-2018