FDAJune 13, 2017device
VNS 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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.
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 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
- FDAVNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.2015-03-06
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