Boston Scientific recalls certain Nitinol Thermocouple Electrodes (TCN-15) due to incorrect Instructions for Use packaging. This may affect safe medical use. Affected units have specific lot numbers.
The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
Boston Scientific is recalling certain Nitinol Thermocouple Electrodes (TCN-15) because the instructions for use were incorrectly packaged. This could lead to improper medical procedures if the device is used without the correct guidance.
The recall is due to incorrect Instructions for Use packaging, which could lead to improper medical procedures if the device is used without the correct guidance. This is a documentation issue, not a physical defect in the device itself.
Healthcare professionals who use these electrodes for pain treatment may be affected. Patients using the device under medical supervision are not at direct risk from this recall.
Check for the model TCN-15 with lot numbers 23014533, 23049687, 23049688, or 23192881. The device is used for RF heat lesioning of peripheral nerve tissue in pain treatment.
Verify that the device comes with the correct Instructions for Use as provided by Boston Scientific.
No, the device itself is safe but the incorrect Instructions for Use packaging could lead to improper medical procedures if not addressed.
Check the lot number on the device to see if it's affected. If it is, you should verify the Instructions for Use are correct.
Look for the model TCN-15 with lot numbers 23014533, 23049687, 23049688, or 23192881.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1696-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1696-2020 from Boston Scientific. 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.
