Food, drugs, devices › Cyberonics, Inc
Device recall: VNS Therapy Programmer, Model 3000, v1.0 System
FDA enforcement event 80062 is a device recall by Cyberonics, Inc of Houston, TX, initiated 13 Nov 2017 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 31 Oct 2022. Initiation: voluntary: firm initiated. Cyberonics, Inc has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Cyberonics, Inc, Houston, TX.
Reason for recall
"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…"
Distribution
"AL, CA, CO, DE, FL, GA, ID, IL, IN, ME, MO, MS, NC, NJ, NY, PA, TN, TN, TX, UT, WA and WI"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2255-2018 | VNS Therapy Programmer, Model 3000, v1.0 System | 252 | Class II | Terminated | 27 Jun 2018 |
Context
Other enforcement events for Cyberonics, Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Dec 2017 | VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: | Device | Class II | 1 |
| 13 Jun 2017 | VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indicati | Device | Class II | 2 |
| 18 Dec 2015 | VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizur | Device | Class II | 1 |
| 18 Nov 2015 | Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106 | Device | Class II | 1 |
| 7 Oct 2015 | Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106 | Device | Class II | 1 |
| 6 Mar 2015 | VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC. | Device | Class II | 1 |
| 20 Nov 2014 | Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS | Device | Class II | 1 |
All 8 events for Cyberonics, Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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…"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "AL, CA, CO, DE, FL, GA, ID, IL, IN, ME, MO, MS, NC, NJ, NY, PA, TN, TN, TX, UT, WA and WI"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 31 Oct 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.