Medtronic Neuromodulation has recalled 534 Enhanced Verify Evaluation Handsets (model HH90130FA) because they may fail to communicate with the neurostimulator. This issue occurs because these handsets have a faster processing speed than previous versions, which can lead to a connection failure and the display of a system error. If the connection is lost, therapy stops being delivered, which can cause the patient's underlying symptoms to return. No injuries or incidents have been reported to date.
The device's inability to connect to the neurostimulator causes therapy to stop, which may result in a return of symptoms like overactive bladder, urinary retention, or fecal incontinence. This interruption occurs during the patient's evaluation period when stimulation response is being monitored.
Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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