FDA recall, , Moderate risk
Axonics PNE Lead Implant Kit
The PNE Lead Implant Kit may leak, break, or experience other issues that may pose a risk to users.
Summary by Recall Canary from the FDA notice
What happened
Axonics, Inc. is recalling the PNE Lead Implant Kit REF: 1701 because the 10mL luer lock syringes included in the kit may leak, break, or experience other issues that may pose a risk to users. The recall began on July 15, 2024, and was added to the FDA's Enforcement Report on October 16, 2026.
The recalled kits were distributed nationwide in the United States, including in states such as Florida, Alabama, Nebraska, California, New York, and Michigan, as well as in the United Kingdom and Australia. The recall involves 18,294 kits.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
PNE Lead Implant Kit REF: 1701
- UDI-DI
- 10810005340134
- Lot code
- 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
- AK1Z731003
- AK1Z731004
- AK1Z731005
- AK1Z731006
- AK1Z731007
- AK1Z731008
- AK1Z731009
- AK1Z731010
- AK1Z731011
- AK1Z731012
- AK1Z731013
- AK1Z731014
- AK1Z731015
- AK1Z731016
- AK1A731017
- AK1A731018
- 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
- AK1A831013
- 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
- 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
- AK1A141008
- AK1A141010
- AK1A141011
- AK1A141012
- AK1A141013
- AK1A141014
- AK1A141015
- AK1A141016
- AK1A141017
- AK1A141018
- AK1A141019
- AK1A141020
- AK1A141021
- AK1A141022
- AK1A341001
- AK1A341002
- AK1A341003
- AK1A341004
- AK1A341005
- AK1A241007
- AK1A241009
- AK1A241010
- AK1A241011
- AK1A241012
- AK1A241013
- AK1A241014
- AK1A241015
- AK1A241016
- AK1A241017
- AK1A241018
- AK1A241019
- AK1A241020
- AK1A241021
- AK1A241022
- AK1A241023
- AK1A241024
- AK1A241025
- AK1A241026
- AK1A341006
- AK1A341007
- AK1A341008
- AK1A341009
- AK1C341021
- AK1C341022
- AK1C441003
- AK1C441004
- AK1C441005
- AK1C441006
- AK1C441007
- AK1C441009
- AK1D441010
- AK1Z531001
- AK1Z531002
- AK1Z531003
- AK1Z531004
- AK1Z531005
Recall details
- Company began the recall
- Sold in
US Nationwide distribution including in the states of Florida, Alabama, Nebraska, California, New York,Michigan, South Carolina, Illinois, North Carolina, Kentucky, Virginia, Colorado, Kansas, Arizona, Ohio, Minnesota, Pennsylvania, North Dakota, Maryland, Oklahoma, Georgia, Arkansas, Wisconsin, Texas, South Dakota, Connecticut, Indiana, Louisiana, Washington, Oregon, West Virginia, Massachusetts, Tennessee, Montana, New Jersey, Delaware, Maine, New Mexico, Iowa, New Hampshire, Missouri, Nevada, Mississippi, District of Columbia, Idaho, Vermont, Wyoming, Utah and the countries of United Kingdom & Australia.
- Company
- Axonics, Inc.
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99907
- Recall number
- Z-0198-2027
- Quantity recalled
- 18,294 kits
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
