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Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US recallZ-2257-2024 · Nalu Medical, Inc. · initiated Jun 3, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Nalu Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On 6/3/24, recall notices were mailed and emailed to Physicians managing patients with Implanted Pulse Generators (IPG) who were informed of the following: 1) Four of the IPGs have been found to have low RF efficiency readings. 2) Firm recommends monitoring the patients with IPGs with low RF efficiency readings through healthcare visits that occur to ensure proper functioning of the Neurostimulation Kit/Peripheral Nerve Stimulation Kit and working with your field representative to address any issues in the event the device is not performing as intended since there are other factors that could cause similar product behaviors. If troubleshooting is unable to restore functionality, it is recommended that you make a clinical assessment around replacement surgery. Ultimately, the decision to act and/or communication with the patient will be at your discretion. 3) If you find a device that has been identified as part of the recalled product to be nonfunctional, you should notify us immediately through your local sales representative, our technical support line at (800) 618-3402 4) Complete and return the response form via email to [email protected] 5) If you have any questions, please call your local sales representative at (480) 313-9745.

Recall details

Recall number
Z-2257-2024
Status
Open, Classified
Initiated by the company
Jun 3, 2024
Posted by the FDA
Jul 3, 2024
Recalling firm
Nalu Medical, Inc.
Quantity
13
Product code
GZF
FDA submissions
K183047, K183579
Distribution
US Nationwide distribution in the states of MO, IL, CA, TX, TN, OK, AZ, AR.

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

8 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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