The Recall Desk

FDA (Devices) recall action 77698

Cyberonics, Inc recalled 2 products on 2017-08-23

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2017-08-23
Critical
0
Units
2,305

Why these products were recalled

Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2017-08-23

    Cyberonics Recalls VNS Therapy Generators Due to Reduced Longevity

    Cyberonics is recalling 1,909 VNS Therapy AspireHC and AspireSR generators because a manufacturing defect may cause them to lose battery life faster than expected.

    Product
    VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 106. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults an
    Category
    Distribution
    50 states
  • HighFDA (Devices)··2017-08-23

    Cyberonics Recalls VNS Therapy Generators Due to Reduced Longevity

    Cyberonics is recalling 396 VNS Therapy AspireHC and AspireSR generators because a manufacturing defect may cause the devices to lose power faster than expected.

    Product
    VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults an
    Category
    Distribution
    50 states