Cyberonics, Inc: Medical Device Recall in 2014 - (Recall #: Z-0858-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.

Product Classification:

Class II

Date Initiated: November 20, 2014

Date Posted: December 31, 2014

Recall Number: Z-0858-2015

Event ID: 69844

Reason for Recall:

The recalled product was distributed with an incorrect serial number printed on the device's label.

Status: Terminated

Product Quantity: 1 unit

Code Information:

Serial Number: 31309; UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705.

Distribution Pattern:

Distributed to PA.

Voluntary or Mandated:

Voluntary: Firm initiated