Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
Check against the official notice below — it lists the full affected range.
Boston Scientific Neuromodulation Corporation Cosman TCN Electrode Correction
Boston Scientific Neuromodulation Corporation initiated a voluntary correction of 40 units of Cosman TCN Electrodes (Nitinol Thermocouple Electrode, 15 cm, 3m Cable) distributed nationwide across 23 states. The products involved were Lot Number 23049684 with GTIN 00813250017519. The correction was necessary because these units were packaged with an incorrect revision of the Instructions for Use.
The TCN Electrode is used in RF heat lesioning of peripheral nerve tissue. The source document does not specify a remedy or action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Nationwide distribution in the states of AZ, CA,CO, FL,GA, ID,IL, IN, KY, MA, MD, MI, MO, NV, NY, OH, OK, OR, SC, TX, UT, VA, WA, and WI. Quantity: 40 units Lot/code info: TCN-15-3M; GTIN: 00813250017519; Lot Number:23049684
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.