Moderate FDA (Devices)·Z-1526-2015·Announced 2015-05-06

Cyberonics Recalls VNS Therapy DemiPulse Generators Due to Battery Defect

Cyberonics is recalling 13 VNS Therapy DemiPulse Generators because they were left in an ON state during manufacture, causing lower battery longevity than specified.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves reduced battery longevity due to a manufacturing error, which is a functional defect rather than an immediate risk of serious injury or death, fitting the criteria for a moderate severity recall.

Plain-English summary

Cyberonics, Inc. is recalling 13 units of VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104. The recall affects specific serial numbers: 37627, 38473, 38539, 41446, 42887, 43491, 44186, 44339, 44391, 44443, 44455, 44510, and 50715.

The devices are being recalled because they have a lower battery longevity than specified in their design requirements. This issue occurred because the devices were inadvertently left in a programmed ON state during the manufacturing process.

The affected units were distributed in Arkansas, Texas, Georgia, California, Michigan, Indiana, Florida, Arizona, and Nevada. Patients using these devices should contact their healthcare provider or Cyberonics for further instructions regarding the recall.

The recalled product

Product: VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
Manufacturer: Cyberonics, Inc
Category: Medical Device — Neurostimulation
Hazard: battery-defect
manufacturing-error
Affected units: 13

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

Serial Numbers: 37627
38473
38539
41446
42887
43491
44186
44339
44391
44443
44455
44510
50715

Distribution

Distributed in 9 states:

Same manufacturer · Cyberonics, Inc

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Same hazard · battery defect