Houston, TX, United States
Cyberonics, Inc recalls
2 recalls recorded since 2018, most recently on 2 December 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 2 December 2017
- Terminated
- 6 August 2018
- Reason
- Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.
- Distribution
- US Distribution to the states of : CO and ND
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0555-2018
- VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing t
Terminated Class II Medical devices
- Recall started
- 13 November 2017
- Terminated
- 31 October 2022
- Reason
- Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. During these programming events, the miscalculations can lead to: " Delivery of more stimulation than intended, resulting in painful stimulation or other common side effects (Model 106 only); " No stimulation in the case of device disablement (Burst Watchdog Timeout), resulting in no therapy to the patient (Model 106 only); " Delivery of less stimulation than intended, resulting in therapeutic settings not being achieved within device specification (Models 103, 104, 105, or 106); and/or " Delays or absence of the 75% and 50% battery life indicators displayed by the programming software (Models 103, 104, 105, or 106).
- Distribution
- AL, CA, CO, DE, FL, GA, ID, IL, IN, ME, MO, MS, NC, NJ, NY, PA, TN, TN, TX, UT, WA and WI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2255-2018
- VNS Therapy Programmer, Model 3000, v1.0 System
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.