AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.
Published September 4, 2019 · Recall initiated: April 16, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon encountered an issue after implanting four Ad-Tech depth electrodes. Upon initial device testing subsequent to implantation it was identified that two of the devices that were labeled as 8 contact depth electrodes (SD08R-SP05X-000) were in fact 6 contact depth electrodes (SD06R-SP05X-000) . There was no impact to the patient due to this incident.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ad-Tech Medical Instrument Corporation
- Distributor
- Worldwide - Nationwide distribution in the state of Illinois and countries of Russia and United Kingdom
- Lot
- Catalog Numbers SD08R-SP05X-000 SD06R-SP05X-000 LOT NUMBERS 127219 208140699 127357 208140699
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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