FDA-Device2026-10-16Class IIPACKAGING DEFECT
Axonics PNE Lead Implant Kit recalled for defective syringes that may leak or break
What this means
Axonics has recalled certain lots of its PNE Lead Implant Kit because the 10mL luer lock syringes included in the kit may leak, break, or malfunction. This could affect the safe use of the implant procedure. The recall affects approximately 18,294 kits distributed nationwide and internationally.
- Check your implant kit lot number against the affected lots listed in the recall notice
- Contact your healthcare provider or Axonics if you have an affected kit
- Do not use an affected kit until you receive guidance from your provider or the manufacturer
The agency's original wording
Hazard
Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
18,294 kits
Manufactured in
26 Technology Dr, Irvine, California, United States
Products
PNE Lead Implant Kit
REF: 1701
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0198-2027Want us to check the next one for you?
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