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

Recall date

August 16, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3253-2018

FDA classification

Class III

Brand / firm

Medtronic Vascular

Sold / distributed

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

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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