Lower riskMedical device recall · FDA · Published August 24, 2020
Irvine Biomedical Recall: Steerable Catheter Model Mixup Risks Wrong Signals
Irvine Biomedical recalls steerable diagnostic catheters with incorrect model numbers that could cause procedure delays if misused. Affected units include specific batch numbers.
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
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Contact the company
📍Recalling firmIrvine Biomedical Inc, a St. Jude Medical Co.2375 and 2382 Morse Ave · Irvine, CA 92614-6234
“Irvine Biomedical Recall: Steerable Catheter Model Mixup Risks Wrong Signals.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64438-irvine-biomedical-recall-steerable-catheter-model-mixup-risks-wrong-signals. Based on FDA recall #Z-3011-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3011-2020%22&limit=1).
The FDA announced on August 24, 2020, that Irvine Biomedical Inc., a St. Jude Medical Co., is recalling Inquiry Steerable Diagnostic Catheters because packages contained incorrect models. This labeling error could result in procedure delays if physicians fail to observe the catheter differences.
According to the FDA, packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Conversely, 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, which could result in procedure delay.
Context
GovInfoNow's records show other recent recalls of similar products include Medline Medical Procedure Kits Recall: Catheter Issues (2026-05-04) and Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray Recall: Erroneous Safety Indicator Risk (2025-11-06).
How to tell if you have this one
Check for model numbers IBI-81104 (batch 7397352) or IBI-87002 (batch 7397307) on the catheter packaging. The recall covers specific batches sold for diagnostic heart procedures.
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - U.S. Nationwide distribution including the states of MO, IN, WI, TX, AZ, MI, VA, KY and the country of Japan.
Recall number
Product, codes & lots
Quantity
Z-3011-2020
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
15 units
Z-3012-2020
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
40 units
Based on the official FDA remedy
What to do — step by step
Check Model Numbers
Look for model numbers IBI-81104 (batch 7397352) or IBI-87002 (batch 7397307) on the catheter packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - U.S. Nationwide distribution including the states of MO, IN, WI, TX, AZ, MI, VA, KY and the country of Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Indiana, Kentucky, Michigan, Missouri, Texas, Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3011-2020 (August 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3011-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.