Cyberonics, Inc: Medical Device Recall in 2016 - (Recall #: Z-0645-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106

Product Classification:

Class II

Date Initiated: November 18, 2015

Date Posted: January 27, 2016

Recall Number: Z-0645-2016

Event ID: 72698

Reason for Recall:

Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the potential for decreased battery longevity.

Status: Terminated

Product Quantity: 29 units

Code Information:

Serial numbers 36602, 37019, 39097, 40311, 40465

Distribution Pattern:

US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated