Cyberonics, Inc: Medical Device Recall in 2015 - (Recall #: Z-1526-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.

Product Classification:

Class II

Date Initiated: March 6, 2015

Date Posted: May 6, 2015

Recall Number: Z-1526-2015

Event ID: 70804

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.

Status: Terminated

Product Quantity: 13 units

Code Information:

Serial Numbers: 37627, 38473, 38539, 41446, 42887, 43491, 44186, 44339, 44391, 44443, 44455, 44510, 50715

Distribution Pattern:

AR, TX, GA, CA, MI, IN, FL, AZ, NV

Voluntary or Mandated:

Voluntary: Firm initiated