Cyberonics recalls VNS Therapy AspireSR Model 106 generators with serial numbers 36519-43201 due to premature battery depletion from electrical leakage in circuit boards.
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 VNS Therapy AspireSR Model 106 generators that may experience premature battery depletion. This issue could lead to the device stopping working unexpectedly, potentially affecting medical treatment for patients with vagus nerve stimulation.
The generators have electrical leakage on the circuit boards that causes premature battery depletion. This means the device may stop working unexpectedly, which could disrupt medical treatment for patients using vagus nerve stimulation.
Patients using Cyberonics VNS Therapy AspireSR Model 106 generators with the listed serial numbers are affected. Those with the device are most at risk as the battery may deplete unexpectedly.
Check your Cyberonics VNS Therapy AspireSR Model 106 generator for serial numbers listed in the range 36519 to 43201. The device was sold between September 30, 2016, and February 28, 2017.
Look for the serial number on your Cyberonics VNS Therapy AspireSR Model 106 generator. If it matches the list of numbers from 36519 to 43201, it is affected.
The recall is for premature battery depletion caused by electrical leakage on the circuit boards of the Model 106 generators.
The recall record does not specify a remedy, so affected users should contact Cyberonics for guidance.
The recall record does not mention any risk of serious injury; the hazard is limited to potential device failure.
We’ve drafted a message you can send Cyberonics to request your refund or repair — edit it as you like.
Subject: Recall Z-0869-2020 — Cyberonics Cyberonics Hello, I own a Cyberonics that is covered by recall Z-0869-2020 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.
