Enhanced Verify Evaluation Handset (CFN HH90130FA)

FDA device recall Z-1704-2025 · posted 2025-04-30 · Open, Classified

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.

Action taken

Firm began notifying Medtronic representatives on April 3, 2025. If impacted devices were found to be with a consignee, the representative will connect with the consignee to provide a copy of the Customer Letter, obtain a signed copy of the Customer Confirmation Form, and retrieve the impacted device. Customers were informed that their Medtronic representative will collect the affected devices and arrange for replacement devices.

Root cause

Device Design

Status

Open, Classified

Product code

EZW

Quantity affected

534

Distribution

US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MD, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, TX, WA, WI.

Date initiated

2025-04-03

Date posted

2025-04-30

Location

Minneapolis, MN