Boston Scientific recalls certain Nitinol Thermocouple Electrodes (5cm) due to incorrect Instructions for Use packaging. This may lead to improper use of the device for nerve pain treatment.
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 specific Nitinol Therm: 5cm electrodes because the packaging includes incorrect instructions for use. This could lead to improper application during nerve pain treatment procedures.
The electrodes are temperature-sensing probes for nerve pain treatment. Incorrect instructions could lead to improper use, but the hazard is not described as causing injury in normal use.
Healthcare professionals using the Cosman TCN Electrodes for nerve pain treatment may be affected. Those with Lot Numbers 23263846 or 23263848 are most at risk.
Check for Lot Numbers 23263846 or 23263848 on the packaging. The product is a 5cm Nitinol Thermocouple Electrode used for RF heat lesioning of nerve tissue.
Look for Lot Numbers 23263846 or 23263848 on the packaging.
Boston Scientific initiated a voluntary correction due to incorrect Instructions for Use being packaged with these electrodes.
The hazard is incorrect Instructions for Use, which could lead to improper application during nerve pain treatment procedures.
Check for Lot Numbers 23263846 or 23263848 on the packaging of the 5cm Nitinol Thermocouple Electrode.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1698-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1698-2020 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.
