Cyberonics recalls specific VNS Therapy AspireHC Model 105 generators due to premature battery depletion from electrical leakage. Affected units have serial numbers 35794-39731 and were sold between February 2017 and May 2017.
This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on the circuit board assemblies of the Models 105 and 106 generators. *Note this recall occurred in November 2018.
Cyberonics is recalling certain VNS Therapy AspireHC Model 105 generators that may experience premature battery depletion due to electrical leakage. This could lead to the device stopping working unexpectedly, which is dangerous for patients using the vagus nerve stimulator.
The generators may experience premature battery depletion because of electrical leakage on the circuit board assemblies. This can cause the device to stop working unexpectedly, potentially disrupting the patient's treatment.
Patients using Cyberonics VNS Therapy AspireHC Model 105 generators with serial numbers listed in the recall are affected. Those with the specific serial numbers and purchase dates between February 2017 and May 2017 are most at risk.
Check your Cyberonics VNS Therapy AspireHC Model 105 generator for a serial number starting with 35794 and ending with 39731. The device was sold between February 25, 2017, and May 1, 2017.
Look for the serial number on your Cyberonics VNS Therapy AspireHC Model 105 generator to see if it matches the listed numbers (35794-39731).
Reach out to Cyberonics customer support to confirm if your device is affected and get instructions for next steps.
Cyberonics is recalling these generators because they may experience premature battery depletion due to electrical leakage on the circuit board assemblies.
The affected serial numbers range from 35794 to 39731, including specific numbers like 35794, 37762, 37792, and 39731.
These generators were sold between February 25, 2017, and May 1, 2017.
We’ve drafted a message you can send Cyberonics to request your refund or repair — edit it as you like.
Subject: Recall Z-0868-2020 — Cyberonics Cyberonics Hello, I own a Cyberonics that is covered by recall Z-0868-2020 from Cyberonics. 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.