CLASS II Device recall · Reported 22 Apr 2020 · FDA Enforcement Report
Nitinol Thermocouple Electrode recalled by Boston Scientific
Boston Scientific Neuromodulation is recalling Nitinol Thermocouple Electrode, distributed nationwide in the US. The recall was initiated on 30 May 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1698-2020
- FDA event ID
- 85085
- Recalling firm
- Boston Scientific Neuromodulation, Valencia, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 May 2019
- FDA classified
- 10 Apr 2020
- Reported
- 22 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 30 May 2019 | Recall initiated by company | |
| 10 Apr 2020 | Classified by FDA | +316 days |
| 22 Apr 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide ArizonaCaliforniaColoradoFloridaGeorgiaIdahoIllinoisIndianaKentuckyMassachusettsMarylandMichiganMissouriNevadaNew YorkOhioOklahomaOregonSouth CarolinaTexas
Questions about this recall
Why was it 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 lots are affected?
Nitinol Thermocouple Electrode, 5 cm; GTIN:00813250013047; Lot Numbers: 23263846 and 23263848.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 85085More recalls from Boston Scientific Neuromodulation
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Infinion Cx Lead Kit recalled by Boston Scientific | Boston Scientific Neuromodulation | Other | NY |
| Device | CLASS II | Intracept Access Instruments, Description recalled by Boston Scientific | Boston Scientific Neuromodulation | Sterility | Nationwide |
| Device | CLASS II | Boston Scientific TCN Electrodes recalled | Boston Scientific Neuromodulation | Device Malfunction | Nationwide |
| Device | CLASS II | Boston Scientific recalled | Boston Scientific Neuromodulation | Sterility | Nationwide |
| Device | CLASS II | Boston Scientific CSK Electrodes recalled | Boston Scientific Neuromodulation | Device Malfunction | Nationwide |
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