Summary
The FDA issued a Class II for PNE Lead Implant Kit REF: 1701 by Axonics, Inc.. Reason: Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users..
Details
Source
Device Recall
External ID
Z-0198-2027
Action Date
2026-10-28
Status
Ongoing
Category
device
Product Description
PNE Lead Implant Kit REF: 1701
Lot/Code Info: UDI: 10810005340134/ Lots: AK1Z531006 AK1Z531009 AK1Z531010 AK1Z531011 AK1Z531012 AK1Z531013 AK1Z531014 AK1Z531007 AK1Z531008 AK1Z531015 AK1Z531016 AK1Z531017 AK1Z531018 AK1Z531019 AK1Z631001 AK1Z631002 AK1Z631003 AK1Z631006 AK1Z631007 AK1Z631008 AK1Z631009 AK1Z731001 AK1Z731002 AK1Z631004 AK1Z631005 AK1Z731002 AK1Z731003 AK1Z731004 AK1Z731005 AK1Z731006 AK1Z731007 AK1Z731008 AK1Z731008 AK1Z731009 AK1Z731010 AK1Z731011 AK1Z731012 AK1Z731013 AK1Z731014 AK1Z731015 AK1Z731016 AK1A731017 AK1A731018 AK1A731019 AK1A731019 AK1A731020 AK1A731021 AK1A731022 AK1A731023 AK1A731024 AK1A731025 AK1A831001 AK1A831002 AK1A831004 AK1A831005 AK1A831006 AK1A831007 AK1A831008 AK1A831012 AK1A931006 AK1A931007 AK1A931008 AK1A931009 AK1A931010 AK1A931011 AK1A931012 AK1A931013 AK1A931014 AK1A931015 AK1AC31001 AK1AC31002 AK1AC31003 AK1AC31004 AK1AC31005 AK1A831003 AK1A831009 AK1A831010 AK1A831011 AK1A831012 AK1A831013 AK1A931015 AK1A931016 AK1A931017 AK1A931018 AK1A931019 AK1AA31001 AK1AA31002 AK1AA31003 AK1AA31004 AK1AA31005 AK1AA31006 AK1AA31007 AK1AA31008 AK1AA31009 AK1AA31010 AK1AA31011 AK1AA31012 AK1AA31013 AK1AA31014 AK1AA31015 AK1AA31016 AK1AA31017 AK1AA31018 AK1AA31019 AK1AA31020 AK1AA31021 AK1AB31001 AK1AB31002 AK1AB31003 AK1AB31004 AK1AB31005 AK1AB31006 AK1AB31007 AK1AB31008 AK1AB31009 AK1AB31010 AK1LB31001 AK1LB31002 AK1AB31011 AK1AB31012 AK1AB31013 AK1AB31014 AK1AB31015 AK1LB31003 AK1AC31001 AK1AC31005 AK1AC31006 AK1AC31007 AK1AC31008 AK1AC31009 AK1AC31010 AK1AC31011 AK1AC31012 AK1AC31013 AK1AC31014 AK1AC31015 AK1AC31016 AK1AC31017 AK1AC31018 AK1AC31019 AK1A141001 AK1A141002 AK1A141003 AK1A141004 AK1A141005 AK1A141006 AK1A141007 AK1A141009 AK1A141023 AK1A141024 AK1A141025 AK1A141026 AK1A141027 AK1A241000 AK1A241002 AK1A241003 AK1A241004 AK1A241005 AK1A241006 AK1A241008 AK1A831014 AK1A831015 AK1A831016 AK1A831017 AK1A831018 AK1A831019 AK1A831020 AK1A931001 AK1A931002 AK1A931003 AK1A931004 AK1A931005 AK1AA31001 AK1A141008 AK1A141010 AK1A141011 AK1A141012 AK1A141013 AK1A141014 AK1A141015 AK1A141016 AK1A141017 AK1A141018 AK1A141019 AK1A141020 AK1A141021 AK1A141022 AK1A141023 AK1A341001 AK1A341002 AK1A341003 AK1A341004 AK1A341005 AK1A241006 AK1A241007 AK1A241008 AK1A241009 AK1A241010 AK1A241011 AK1A241012 AK1A241013 AK1A241014 AK1A241015 AK1A241016 AK1A241017 AK1A241018 AK1A241019 AK1A241020 AK1A241021 AK1A241022 AK1A241023 AK1A241024 AK1A241025 AK1A241026 AK1A341005 AK1A341006 AK1A341007 AK1A341008 AK1A341009 AK1C341021 AK1C341022 AK1C441003 AK1C441004 AK1C441005 AK1C441006 AK1C441007 AK1C441009 AK1D441010 AK1Z531001 AK1Z531002 AK1Z531003 AK1Z531004 AK1Z531005 AK1Z531006
Quantity Affected: 18,294 kits
Reason for Recall
Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-15
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 187 device recalls issued in the same week, part of 480 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Axonics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Axonics, Inc. have FDA actions?
This is the only FDA action we have on record for Axonics, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0198-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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