Ad-Tech recalls Spencer Probe Depth Electrodes with incorrect contact count that may cause improper brain mapping during surgery. The recall addresses a manufacturing error where some units were labeled as 8-contact but are actually 6-contact.
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.
Ad-Tech is recalling Spencer Probe Depth Electrodes that were mistakenly labeled as 8-contact but are actually 6-contact. This error could lead to improper brain mapping during surgery, though no patient injuries occurred in the identified incident.
The electrodes were manufactured with a different contact count than labeled. This could result in improper brain mapping during surgery, potentially affecting the accuracy of locating epileptogenic foci. However, no patient injuries occurred in the reported incident.
Surgical teams using Ad-Tech Spencer Probe Depth Electrodes for brain mapping procedures. Patients undergoing neurosurgery with these electrodes are at risk of inaccurate brain mapping.
Check for catalog numbers SD08R-SP05X-000 or SD06R-SP05X-000. The product was sold with lot numbers 127219, 208140699, and 127357.
Look for catalog numbers SD08R-SP05X-000 or SD06R-SP05X-000 on the device.
The recall is due to a manufacturing error where some units were labeled as 8-contact but are actually 6-contact, which could affect brain mapping accuracy during surgery.
No patient injuries occurred in the incident that identified the issue.
Check for catalog numbers SD08R-SP05X-000 or SD06R-SP05X-000 with lot numbers 127219, 208140699, or 127357.
We’ve drafted a message you can send Ad-Tech to request your refund or repair — edit it as you like.
Subject: Recall Z-2396-2019 — Ad-Tech Ad-Tech Hello, I own a Ad-Tech that is covered by recall Z-2396-2019 from Ad-Tech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
