Due to out of the box wobble of the driver.
Medtronic Xomed
26 recalls • • Categories: Surgical Instruments, Diagnostic Equipment, Other Medical Devices, Infusion Pumps, Implants & Prosthetics
Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.
Class I - Dangerous
Product was distributed past expiration date.
Potential for false negative response on the NIM Vital Nerve Monitoring System
Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,
Class I - Dangerous
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
Class I - Dangerous
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
Class I - Dangerous
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
Class I - Dangerous
Software anomaly was identified.
Class I - Dangerous
Software anomaly was identified.
As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between the set number of rotations and the actual number of rotations in a specific mode when the product was used with our company's M5 handpiece.
Class I - Dangerous
There is potential for multiple issues due to a manufacturing nonconformity.
There was an increase in complaints related to tip breaks and wobble/vibration.
There was an increase in complaints related to tip breaks and wobble/vibration.
There was an increase in complaints related to tip breaks and wobble/vibration.
During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the set value in the cosole.
Class I - Dangerous
Routine sterilization dose does not meet the required Sterility Assurance Level.
Class I - Dangerous
Routine sterilization dose does not meet the required Sterility Assurance Level.
Class I - Dangerous
Routine sterilization dose does not meet the required Sterility Assurance Level.
Class I - Dangerous
Wire in tubing can become exposed, posing potential harm to the intubated patient.
Class I - Dangerous
One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'PREVACUUM ONLY"
In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in the intraoperative cuff deflation which then requires re-inflation or replacement of the deflated tube in order to ensure the continued ventilation of the patient.
In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu
In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu
In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu