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.
Reported: April 22, 2020 Initiated: May 30, 2019 #Z-1698-2020
Product Description
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.
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.
Details
- Recalling Firm
- Boston Scientific Neuromodulation Corporation
- Units Affected
- 43 units
- 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.
- Location
- Valencia, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Boston Scientific Neuromodulation Corporation. Units affected: 43 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 22, 2020. Severity: Moderate. Recall number: Z-1698-2020.
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