Irvine Biomedical recalls certain Inquiry Steerable Diagnostic Catheters with incorrect model packaging. Using the wrong model may cause inaccurate electrograms during cardiac procedures, leading to delays. 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 specific batches of Inquiry Steerable Diagnostic Catheters that were incorrectly labeled. If doctors use the wrong model during cardiac procedures, the electrograms might not be accurate, causing delays in treatment.
The catheters were packaged with the wrong model number. This means doctors might use the incorrect type during cardiac studies, which could lead to inaccurate electrograms and procedure delays.
Physicians using the recalled catheters for cardiac procedures are most at risk. Patients undergoing these procedures may experience delays if the catheters are misused.
Check for model numbers IBI-81104 (batch 7397352) or IBI-87002 (batch 7397307) on the packaging. The product was sold with GTIN 05414734309936 and lot number 7397307.
Verify the model number on the packaging to ensure it matches the correct batch.
Model IBI-81104 (batch 7397352) and Model IBI-87002 (batch 7397307) are affected.
The recall is happening because the catheters were packaged with the wrong model number, which could lead to inaccurate electrograms during cardiac procedures.
Check the model number on the packaging to ensure it matches the correct batch. If you have the wrong model, 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-3012-2020 — Irvine Biomedical Irvine Biomedical Hello, I own a Irvine Biomedical that is covered by recall Z-3012-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
