Enhanced Verify Evaluation Handset May Fail to Connect to Neurostimulator
Medtronic Enhanced Verify Evaluation Handsets (CFN HH90130FA) may fail to communicate with neurostimulators due to faster processing speed, causing therapy to stop and patients to experience return of underlying symptoms.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a device communication failure that directly impacts therapy delivery, potentially causing patient harm through return of serious underlying disease symptoms. Class II recalls with risk of significant patient impact align with a Severe (4) rating.
Plain-English summary
Medtronic Neuromodulation is recalling the Enhanced Verify Evaluation Handset (CFN HH90130FA) due to a communication issue between the handset and the neurostimulator device. The handsets have a faster processing speed than prior handsets, which may prevent them from connecting to the neurostimulator.
When the handset cannot connect, therapy delivery stops and a system error is displayed. Patients may then experience return of their underlying disease symptoms, including overactive bladder, urinary retention, or fecal incontinence, depending on their response to stimulation during the evaluation period.
A total of 534 affected units with various serial numbers (NPN0076461 through NPN0077430) have been distributed nationwide across 26 states including Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Texas, Washington, and Wisconsin.
Patients and healthcare providers should contact Medtronic Neuromodulation for further instructions regarding the affected handsets. Healthcare providers should immediately notify patients who have received this handset and verify that they understand the potential risks.
The recalled product
- Product
- Enhanced Verify Evaluation Handset (CFN HH90130FA)
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- communication-failure
- therapy-interruption
- device-malfunction
Distribution
Distributed nationwide across the United States.
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