CLASS II Device recall · Reported 27 Jan 2016 · FDA Enforcement Report
VNS Therapy AspireSR Generator recalled by Cyberonics
Cyberonics is recalling VNS Therapy AspireSR Generator. The recall was initiated on 18 Dec 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0659-2016
- FDA event ID
- 72896
- Recalling firm
- Cyberonics, Houston, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Dec 2015
- FDA classified
- 15 Jan 2016
- Reported
- 27 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Dec 2015 | Recall initiated by company | |
| 15 Jan 2016 | Classified by FDA | +28 days |
| 27 Jan 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled.
Product as listed by the FDA
VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Where it was distributed
Worldwide Distribution -- United States, Austria, Belgium, Croatia, Czech Republic, Finland, France, Germany, Iceland, Italy, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Cyprus, Israel, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, and United Arab Emirates.
Questions about this recall
Is VNS Therapy AspireSR Generator recalled?
Yes. Cyberonics recalled VNS Therapy AspireSR Generator on 18 Dec 2015. The recall is Class II and its status is Terminated. Recall number Z-0659-2016.
Why was it recalled?
Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled.
Which lots are affected?
All VNS Therapy AspireSR (Model 106) Generators; Device Identifier - (01)05425025750061
Where was it sold?
Worldwide Distribution -- United States, Austria, Belgium, Croatia, Czech Republic, Finland, France, Germany, Iceland, Italy, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Cyprus, Israel, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, and United Arab Emirates.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cyberonics
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|---|---|---|---|---|---|
| Device | CLASS II | VNS Therapy Programmer recalled by Cyberonics | Cyberonics | Lead & Heavy Metals | 21 states |
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