Cyberonics Recalls VNS Therapy AspireSR Generators Due to Stimulation Failure
Cyberonics is recalling 4,935 VNS Therapy AspireSR Generators worldwide after three reports of device resets that disabled stimulation output.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (seizure therapy device) where the device failure disables stimulation, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Cyberonics, Inc. is recalling 4,935 units of the VNS Therapy AspireSR Generator Model 106. This medical device is indicated for use as an adjunctive therapy in reducing the frequency of seizures. The recall is being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator.
These events resulted in a device reset condition where the stimulation output is disabled. The affected devices are distributed worldwide, including in the 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. The specific device identifier for the affected units is (01)05425025750061.
Patients using this device should contact their healthcare provider or Cyberonics for further instructions regarding the recall and potential replacement or repair of the device.
The recalled product
- Product
- VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
- Manufacturer
- Cyberonics, Inc
- Affected units
- 4,935
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All VNS Therapy AspireSR (Model 106) Generators
- Device Identifier - (01)05425025750061
Distribution
Distribution scope not specified by the agency.
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