The Recall Desk

Manufacturer

Cyberonics, Inc

9 recalls in our database name Cyberonics, Inc as the manufacturing or recalling firm.

What the numbers show

Total
9
Critical
0
Severe
0
Most recent
2018-06-27

Of the 9 recalls from Cyberonics, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

  • HighFDA (Devices)·Z-2255-2018·2018-06-27

    Cyberonics VNS Therapy Programmer Model 3000 Recalled for Parameter Miscalculation

    Cyberonics is recalling 252 VNS Therapy Programmer Model 3000 units because certain programming events can miscalculate parameters for implanted generators, potentially causing painful stimulation or lack of therapy.

    Product
    VNS Therapy Programmer, Model 3000, v1.0 System
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-0555-2018·2018-02-14

    Cyberonics Recalls Two VNS Therapy Programmer Units Distributed Before Approval

    Cyberonics, Inc. is recalling two VNS Therapy Programmer units that were distributed in error before FDA approval of the specific software version.

    Product
    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 the frequency of seizures in patients 4 years of age and olde
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-3020-2017·2017-08-23

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3019-2017·2017-08-23

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0645-2016·2016-01-27

    Cyberonics VNS Therapy AspireSR Generator Recall for Sensing Delays

    Cyberonics is recalling 29 Model 106 VNS Therapy AspireSR Generators due to delays in heartbeat sensing and potential decreased battery longevity.

    Product
    Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0659-2016·2016-01-27

    Cyberonics Recalls VNS Therapy AspireSR Generators Due to Stimulation Failure

    Cyberonics is recalling 4,935 VNS Therapy AspireSR Generators worldwide after three reports of device resets that disabled stimulation output.

    Product
    VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0280-2016·2015-11-25

    Cyberonics Vagus Nerve Stimulator Recall for Sensing Delays

    Cyberonics is recalling 27 Model 106 Vagus Nerve Stimulator generators due to delays in heartbeat detection and potential decreased battery longevity.

    Product
    Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-1526-2015·2015-05-06

    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.

    Product
    VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Devices)·Z-0858-2015·2014-12-31

    Cyberonics VNS Therapy Generator Recalled for Incorrect Serial Number Labeling

    Cyberonics is recalling one VNS Therapy AspireHC Model 105 Generator distributed in Pennsylvania due to an incorrect serial number on the device label.

    Product
    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 ther
    Category
    Medical Device
    Distribution
    1 state