Irvine Biomedical Inc, a St. Jude Medical Co. recalls Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and…

Recall date

August 24, 2020

Source

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

Recall number

Z-3011-2020

FDA classification

Class II

Brand / firm

Irvine Biomedical Inc, a St. Jude Medical Co.

Sold / distributed

Worldwide distribution - U.S. Nationwide distribution including the states of MO, IN, WI, TX, AZ, MI, VA, KY and the country of Japan.

Why it was recalled

Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307 incorrectly contained Model IBI-81104, batch 7397352.If physicians fail to observe the catheter difference, the intracardiac electrograms will not be representative of the desired signals, could result in procedure delay

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.