Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), R
Summary
The FDA issued a Class II for Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve St by Nalu Medical, Inc.. Reason: Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pul.
Details
Source
Device Recall
External ID
Z-2257-2024
Action Date
2024-07-10
Status
Ongoing
Category
device
Product Description
Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System.
Lot/Code Info: UDI-DI: 71005-US: 00812537036137, 00812537033600, 00812537033518, 00812537030975, 00812537030524. 71019-US: 00812537036441, 00812537035604, 00812537035598 Serial Numbers: H01377, H01382, H01432, H01419, H01387, H01445, H01415, H01441, H01373, H01428, H01378, H01438, H01431
Quantity Affected: 13
Reason for Recall
Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy Disc, causing the IPG to be non-functional, which causes the device to be non-functional so it will no longer inhibit the transmission of pain signals to the brain.
Distribution
US Nationwide distribution in the states of MO, IL, CA, TX, TN, OK, AZ, AR.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-03
Company
Carlsbad, 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 147 device recalls issued in the same week, part of 403 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 (Nalu Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nalu Medical, Inc. have FDA actions?
This is the only FDA action we have on record for Nalu Medical, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2257-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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