Medtronic recalls LEAD 3387S-40 STIMLOC DBS devices due to a discrepancy between Use By Dates on the product and kit labels. Affected units may have expired components.
There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.
Medtronic is recalling a specific type of brain stimulation device (STIMLOC DBS) because the expiration dates on the product label and the kit label don't match. This mismatch could mean the device uses expired components, but it doesn't cause immediate harm.
The device has two different expiration dates: one on the outer kit label and one on the individual product label. If the dates don't match, the device might use expired components, which could lead to reduced effectiveness or potential complications over time.
Patients with Medtronic STIMLOC DBS implants who own the LEAD 3387S-40 model (serial number VA2JV2V) are affected. Those who have the device implanted but don't use it daily are at lower risk.
Check for the model number 3387S-40 on the device and the serial number VA2JV2V. The device is sold as an electrical implantable device for brain stimulation.
Look for the model number 3387S-40 and serial number VA2JV2V on the device and its packaging.
No immediate danger is expected. The recall is due to a date mismatch that could affect long-term device effectiveness, not immediate harm.
Check for the model number 3387S-40 and serial number VA2JV2V on the device and its packaging.
Yes, check the device labels to confirm if you have the recalled model. If you do, contact Medtronic for further instructions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0217-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0217-2024 from Medtronic. 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.