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
Irvine Biomedical is recalling certain steerable diagnostic catheters that were incorrectly labeled with the wrong model numbers. If doctors don't notice the mix-up, the catheter might give inaccurate signals during heart procedures, causing delays.
The catheters were shipped with incorrect model numbers. If doctors don't notice the difference, the electrical signals from the catheter won't match what's needed for the procedure, potentially causing delays but not immediate harm.
Physicians using the specific catheter models and batches listed in the recall are affected. The risk is low as the issue only affects procedure timing, not patient safety directly.
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.
Look for model numbers IBI-81104 (batch 7397352) or IBI-87002 (batch 7397307) on the catheter packaging.
The catheters were shipped with incorrect model numbers, which could lead to inaccurate electrical signals during procedures if not noticed.
The recall does not mention injury risk; it only states that the mix-up could cause procedure delays.
Check the model and batch numbers on the packaging. If it matches the recalled models, contact Irvine Biomedical for guidance.
We’ve drafted a message you can send Irvine Biomedical to request your refund or repair — edit it as you like.
Subject: Recall Z-3011-2020 — Irvine Biomedical Irvine Biomedical Hello, I own a Irvine Biomedical that is covered by recall Z-3011-2020 from Irvine Biomedical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
