VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Check against the official notice below — it lists the full affected range.
Cyberonics, Inc. is recalling the VNS Therapy AspireSR Generator Model 106, a device used as an adjunctive therapy to reduce seizure frequency. The recall was initiated following three reports of "Burst Watchdog Timeout" events that caused the device to reset and disable its stimulation output. Approximately 4,935 units of the Model 106 have been distributed worldwide, including throughout the United States and multiple countries in Europe, the Middle East, and other regions.
The recall affects all VNS Therapy AspireSR Model 106 Generators with Device Identifier (01)05425025750061. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: 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. Quantity: 4,935 units Lot/code info: All VNS Therapy AspireSR (Model 106) Generators; Device Identifier - (01)05425025750061
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.