Recall Z-1704-2025 ยท EZW Stimulator, Electrical, Implantable, For Incontinence
Medtronic Neuromodulation
Enhanced Verify Evaluation Handset (CFN HH90130FA)
| Date | Apr 30, 2025 (initiated Apr 3, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.