Cyberonics, Inc: Medical Device Recall in 2016 - (Recall #: Z-0659-2016)

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:

VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.

Product Classification:

Class II

Date Initiated: December 18, 2015

Date Posted: January 27, 2016

Recall Number: Z-0659-2016

Event ID: 72896

Reason for Recall:

Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled.

Status: Terminated

Product Quantity: 4,935 units

Code Information:

All VNS Therapy AspireSR (Model 106) Generators; Device Identifier - (01)05425025750061

Distribution Pattern:

Worldwide Distribution -- United States, Austria, Belgium, Croatia, Czech Republic, Finland, France, Germany, Iceland, Italy, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Cyprus, Israel, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, and United Arab Emirates.

Voluntary or Mandated:

Voluntary: Firm initiated