FDA-Device2020-09-30Class II
Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - 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.
Irvine Biomedical Inc, a St. Jude Medical Co.
Hazard
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
Sold states
Worldwide distribution - U.S. Nationwide distribution including the states of MO, IN, WI, TX, AZ, MI, VA, KY and the country of Japan.
Affected count
40 units
Manufactured in
2375 and 2382 Morse Ave, N/A, Irvine, CA, United States
Products
Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3012-2020Don't want to check this manually?
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