NuVasive MD Pulse III Multimodality System REF 1881500 recallZ-1052-2023 · NuVasive Inc · initiated Jul 19, 2022
Class III Open, Classified All recalls posted in February 2023
Is my device affected?
- 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.
- If yours is listed, follow the instructions from NuVasive Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- 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
Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures.
FDA root cause category: Software design
What the company is doing
Between 07/19/2022 to 12/02/2022, affected customers were contacted and verbally informed during a software update that there was an issue related to the inability to remotely connect their system and does not allow physicians who is not physically in the operating room to be able to review live neuromonitoring data remotely and provide analysis to the surgeon in the operating room. The firm is planning on sending an "URGENT: MEDICAL DEVICE RECALL" Letter on 01/13/2023, to officially inform customers that a recall is being conducted due to a remote monitoring issue that may potentially not allow a physician who is not physically in the operating room to be able to review live neuromonitoring data remotely and provide analysis to the surgeon in the operating room. Customer Instructions: -Nuvasive, Inc. will contact a Representative at the hospitals to schedule the software key upgrade. -If the security key has been updated, no further action is necessary. For questions or assistance, contact Sr. Director, Global Quality at 858-336-3421 or email [email protected]
Recall details
- Recall number
- Z-1052-2023
- Recall class
- Class III
- Status
- Open, Classified
- Initiated by the company
- Jul 19, 2022
- Posted by the FDA
- Feb 3, 2023
- Recalling firm
- NuVasive Inc
- Quantity
- 7
- Product code
- OLO
- FDA submissions
- K210574
- Distribution
- U.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX.
Product description
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
Code information (models, lots, serial numbers)
Part Number: 1881500 UDI Code: 0887517PLS137YJ Serial Numbers: PM00017 SM90018 SM90013 SM90021 PM00007 SM90032 SM90030
Other devices under the same FDA submission
1 device cleared under K210574 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PULSE 5050401Nuvasive, Inc. · Neurological stereotaxic Instrument1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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