Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Inquiry Steerable Diagnostic Catheter Recalled by Irvine Biomedical Inc, a St. Jude Medical Co. Due to Steerable diagnostic catheter packages labeled Model IBI-81104, batch...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Irvine Biomedical Inc, a St. Jude Medical Co. directly.
Affected 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.
Quantity: 40 units
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Irvine Biomedical Inc, a St. Jude Medical Co.
Irvine Biomedical Inc, a St. Jude Medical Co. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report