FDA Issues High-Risk Safety Communication for Baxter Infusion Pump Recall

On July 1, the FDA issued a high-risk safety communication as part of its effort to strengthen the medical device recall process. Baxter has initiated an urgent recall of certain Sigma Spectrum Infusion Pumps (V6 and V8 platforms) after discovering that incorrect software versions may have been installed. The V6 pumps may have received V8 software and vice versa, potentially leading to overinfusion or underinfusion of fluids and medication due to mismatched pumping mechanisms and differing user interfaces.

The mix-up can result in serious health risks, including drug overdose, fluid overload, or inadequate therapy—particularly dangerous for vulnerable patients.

No injuries or deaths have been reported as of June 12, yet Baxter has advised healthcare providers to immediately identify and remove affected pumps from service, verify software versions, and contact the company for service.

The FDA will continue to monitor the situation and update the public as needed.