Axonics PNE Lead Implant Kit Recall for Syringe Defects
Axonics is recalling PNE Lead Implant Kits because included 10mL luer lock syringes may leak or break, posing a risk to users.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II because the syringes may leak or break, posing a risk to users. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Axonics, Inc. is recalling 18,294 PNE Lead Implant Kits (REF: 1701) due to a defect in the 10mL luer lock syringes included in the kits. The syringes may leak, break, or experience other issues that may pose a risk to users.
The affected kits were distributed nationwide in the United States and in the United Kingdom and Australia. The recall covers specific lots identified by UDI 10810005340134 and various lot numbers listed in the agency record.
Users should contact Axonics, Inc. for instructions on how to proceed with the recall. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- PNE Lead Implant Kit REF: 1701
- Manufacturer
- Axonics, Inc.
- Category
- Medical Device — Implant Kit
- Affected units
- 18,294
Distribution
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