Medical device recalls High risk

Medtronic Inc recalls 6F Taiga Guiding Catheter

Recall date
September 26, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1207-2018
FDA classification
Class I
Brand / firm
Medtronic Inc
Sold / distributed
Japan

Why it was recalled

Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

6F Taiga Guiding Catheter

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