Recall Z-0198-2027 ยท EZW Stimulator, Electrical, Implantable, For Incontinence
Axonics, Inc.
PNE Lead Implant Kit REF: 1701
| Date | Oct 16, 2026 (initiated Jul 15, 2024) |
| Status | Open, Classified |
| Reason | Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users. |
| Root cause | Component change control |
| Action | On August 7, 2024, Axonics, issues a Urgent Medical Device Notification to affected consignees via UPS. Axonics asked consignees to take the following actions: 1. Immediately review your inventory for the Lot Numbers specified in this notification and share this notice and Recall Response Form with the appropriate staff. 2. If you further distributed this product, please notify those entities of this product recall. Please include a copy of this recall notification and Medline Industries notification in your communication. 3. Discard any syringes of the impacted lots. 4. Complete and return |
| Quantity | 18,294 kits |
| Distribution | US Nationwide distribution including in the states of FL, AL, NE, CA, NY,MI, SC, IL, NC, KY, VA, CO, KS, AZ, OH, MN, PA, ND, MD, OK, GA, AR, WI, TX, SD, CT, IN, LA, WA, OR, WV, MA, TN, MT, NJ, DE, ME, NM, IA, NH, MO, NV, MS, DC, ID, VT, WY, UT and the countries of United Kingdom & Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.