Nitinol Thermocouple Electrode, 5cm - 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 initiated a voluntary correction of certain Cosman TCN Electrodes (Nitinol Thermocouple Electrode, 5cm) because incorrect versions of the Instructions for Use were packaged with the products. The affected devices have GTIN 00813250013047 and include lot numbers 23263846 and 23263848, with 43 units distributed nationwide across 23 states including Arizona, California, Florida, New York, Texas, and Washington.
The source does not specify a remedy or recommended action for consumers who may have received affected products.
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: 43 units Lot/code info: Nitinol Thermocouple Electrode, 5 cm; GTIN:00813250013047; Lot Numbers: 23263846 and 23263848.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.