NuVasive Inc NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
Brand
NuVasive Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Part Number: 1881500 UDI Code: 0887517PLS137YJ Serial Numbers: PM00017 SM90018 SM90013 SM90021 PM00007 SM90032 SM90030
NuVasive Inc is recalling NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN due to Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, a. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 pyrigoyen@nuvasive.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026