NuVasive Pulse III Multimodality System remote monitoring connection failure
An incorrect security key prevents the NuVasive Pulse III system from connecting to remote monitoring during spinal, thoracic, and extremity surgeries. Affected facilities should contact NuVasive for corrective action.
What this means for you
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: FDA Class III classification with no reported illnesses or injuries. This is a functional defect without documented patient harm, placing it in the Moderate category per the rubric.
Plain-English summary
The NuVasive MD Pulse III Multimodality System (Part Number 1881500, Software versions 369-BL.US and 369-BLN.US) is being recalled. Seven units of the device have been distributed nationwide in California, Florida, North Carolina, Ohio, and Texas.
The recall is due to an incorrect security key that prevents customers from connecting to remote monitoring during surgical procedures. The affected procedures include spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures.
Affected healthcare facilities should contact NuVasive Inc. for corrective action instructions. The U.S. Food and Drug Administration has classified this as a Class III recall. As of the recall notice, no illnesses or injuries have been reported.
The recalled product
- Product
- NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
- Manufacturer
- NuVasive Inc
- Hazard
- remote-monitoring-failure
- security-vulnerability
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27