Cyberonics, Inc: Medical Device Recall in 2015 - (Recall #: Z-0280-2016)

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:

Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106

Product Classification:

Class II

Date Initiated: October 7, 2015

Date Posted: November 25, 2015

Recall Number: Z-0280-2016

Event ID: 72385

Reason for Recall:

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

Status: Terminated

Product Quantity: 27 units

Code Information:

Serial Numbers: 37719, 37899, 38123, 38414, 38428, 39385, 39531, 39607, 39801, 39821, 40037, 40048, 40249, 40251, 40271, 40354, 40428, 40488, 40526, 40603, 40751, 41000, 41109, 41152, 41805, 42022, 42780

Distribution Pattern:

US Distribution to the states of : OR, NY, GA, PA, CA, NC, KS, FL, KY, MI, TX, IL, OH, IN, UT, CO and WV.

Voluntary or Mandated:

Voluntary: Firm initiated