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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 534
Distribution
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