FDAMarch 6, 2015device
VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The pulse generators have a lower battery longevity than specified in their design requirement as a result of the devices being inadvertently left in a programmed ON state during manufacture.
What to do
FDA enforcement status: Terminated
Brands named
cyberonics
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAVNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset se...2017-12-02
- FDAVNS Therapy Programmer, Model 3000, v1.0 System2017-11-13
- FDAVNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 106. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 ...2017-06-13
- FDAVNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 ...2017-06-13
- FDAVNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.2015-12-18
- FDACyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 1062015-11-18
- FDACyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 1062015-10-07
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