Irvine Biomedical Inc, a St. Jude Medical Co.: 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

Agency Publication Date: September 24, 2020

Affected Products

Product: 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.

GTIN: 05414734302975, Lot: 7397352

Lot Numbers:

7397352

Product: 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.

GTIN: 05414734309936, Lot: 7397307

Lot Numbers:

7397307

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86328

Status: Resolved

Manufacturer: Irvine Biomedical Inc, a St. Jude Medical Co.

Manufactured In: United States

Units Affected: 2 products (15 units; 40 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

GTIN: 05414734302975, Lot: 7397352

Lot Numbers:

7397352

GTIN: 05414734309936, Lot: 7397307

Lot Numbers:

7397307