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.
FDA Recall Z-2396-2019 · Posted None
Recalling FirmAd-Tech Medical Instrument Corporation
Recall StatusTerminated
Product CodeGZL
Date Initiated2019-04-16
Date Terminated2022-05-27
Product Quantity18
Reason for Recall
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.
Firm Action
Via a MEDICAL DEVICVE RECALL letter dated, April 17, 2019, Ad-Tech advised their consignees of the mix-up, requested that they check their stock, returned the MEDICAL DEVICE RECALL RETURN RESPONSE, and return the subject devices. Distributors were requested to conduct a sub-recall to their customers.
Root Cause
Labeling Change Control
Distribution Pattern
Worldwide - Nationwide distribution in the state of Illinois and countries of Russia and United Kingdom
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.