VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
FDA device recall Z-1526-2015 · posted 2015-04-27 · Terminated
Recall details
- Recalling firm
- Cyberonics, Inc
- Reason for recall
- 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.
- Action taken
- On 03/6/2015, the recalling firm sent a recall notification letter to their consignees. The letter included an effectiveness card which is to be signed by the consignee and returned to the recalling firm.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LYJ
- Quantity affected
- 13 units
- Distribution
- AR, TX, GA, CA, MI, IN, FL, AZ, NV
- Date initiated
- 2015-03-06
- Date posted
- 2015-04-27
- Date terminated
- 2015-10-09
- Location
- Houston, TX
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