Reported Feb 15, 2023 · Ongoing

NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US

NuVasive Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: NuVasive Inc · 7475 Lusk Blvd · San Diego, CA · 92121-5707

Is this the product you have?

  • NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
Lot codes and dates
  • Part Number1881500
  • UDI Code0887517PLS137YJ
  • Serial NumbersPM00017 SM90018 SM90013 SM90021 PM00007 SM90032 SM90030
Amount recalled
7

Where it was sold

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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.