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Recall Observatory FDA recall evidence

Device product

Nitinol Thermocouple Electrode, 10 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.

Z-1695-2020

May 30, 2019

Class II

Product summary

Firm
Boston Scientific Neuromodulation Corporation
Event
Event 85085
Status
Terminated
Classification
Class II
Quantity
110 units
Official record key
device-enforcement:Z-1695-2020

Official wording

Reason: 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.

Code information: TCN-10-3M; GTIN: 00813250017502; Lot Numbers: 23049683, 23239528, and 23239529.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.