Axonics, Inc.: Stimulator, Electrical, Implantable, For Incontinence
Recall Summary Axonics is recalling PNE Lead Implant Kits (model 1701) distributed nationwide because the 10mL luer lock syringes included in the kits may leak, break, or malfunction. These syringes are used with electrical stimulator devices that are implanted to treat incontinence. The recall affects patients who received this product across the United States, United Kingdom, and Australia.
- Recalling firm
- Axonics, Inc.
- Product
- PNE Lead Implant Kit REF: 1701
- Reason
- Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2024-07-15
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/fd1d8410-bce6-49af-86e9-ee940a4fa0ee