Boston Scientific recalls certain Nitinol Thermocouple Electrodes due to incorrect Instructions for Use packaging. This may affect safe medical 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 Nitin: 15 cm, 3m cable electrodes because they came with incorrect instructions for use. This could lead to unsafe medical procedures if users follow outdated guidance.
The electrodes have outdated instructions that could lead to improper use. If users follow incorrect guidance, it might cause ineffective or unsafe nerve treatments.
Medical professionals using these electrodes for nerve pain treatment are most at risk. Patients receiving this device for pain management may also be affected.
Check for the model TCN-15-3M with lot number 23049684. These electrodes are used for RF heat lesioning of nerve tissue in pain treatment.
Verify the instructions for use are current and match the product's intended medical application.
Boston Scientific initiated a voluntary correction because the electrodes came with incorrect Instructions for Use (IFU) packaging.
The model number is TCN-15-3M with lot number 23049684.
The official notice does not mention a specific fix or remedy for this recall.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1697-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1697-2020 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.
