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Medtronic Vascular recalls Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Recalled October 3, 2018 · FDA recall Z-3253-2018 · Medtronic Vascular
Hazard
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. · FDA Class III
Units
250 units
Sold at
CA, IA, NE, TN, TX, VA, WA, Jamaica, New Zealand, Thailand
Description
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.
Product
Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Manufacturer(s)
Medtronic Vascular
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →