Two patients are dead and dozens gravely injured after hospitals trusted Baxter’s “cutting-edge” infusion pumps—raising urgent questions about how many more Americans are at risk because Big Medical and federal regulators refuse to pull dangerous devices off the market.
At a Glance
- Baxter’s Novum IQ infusion pumps linked to 2 deaths and 79 severe injuries in U.S. hospitals
- FDA and Health Canada issue urgent safety alerts but allow pumps to remain in use
- Baxter updates instructions but does not recall or remove the device from hospitals
- Over 34,500 pumps still in circulation, putting critical patients at risk
Hospitals Left to Manage the Fallout as Regulators Stall
As of July 2025, Baxter’s Novum IQ Large Volume Pump is still plugged in across more than 34,500 hospital beds in the United States and Canada, despite being directly tied to two deaths and nearly eighty severe injuries. The FDA, ever the bureaucratic behemoth, issued a Class I recall—their highest level alert—warning of potentially fatal dosing errors. Yet, instead of yanking these malfunctioning machines off the market, regulators and the manufacturer opted for a paperwork shuffle: new instructions, a few user advisories, and a shrug to overwhelmed hospital staff.
Hospital administrators and nurses are now scrambling to keep patients safe with “mitigation steps” and fresh rounds of training, rather than being allowed to swap the machines for something that actually works. The FDA’s own notice spells out the risk: the Novum IQ pump can deliver the wrong dose—either too much, too little, or none at all—especially when rates are changed or if the setup is off by even a hair. Yet the government’s answer is to “update instructions” and hope for the best. It’s the kind of approach to public health that makes you wonder whether these agencies exist to protect patients or the profits of medical device giants.
Baxter’s Response: Protecting Reputation Over Patient Safety
Baxter International, a titan in the medical device industry, has so far refused to pull their Novum IQ pumps, instead issuing a flurry of letters and advisories telling hospital staff to be extra careful. Their July 14 customer alert warned of under-infusion risks during rate changes—a problem that can lead to dehydration, missed medications, or even cardiac events, especially in ICU patients and infants. The company’s corrective actions don’t go beyond “updated instructions for use” and recommendations to switch to alternative pumps when possible. But, with tens of thousands of these devices still in active use and hospitals already stretched thin, that’s hardly a solution. The company’s reluctance to recall the product outright hints at what’s really on the line: not just lives, but market share, liability, and the bottom line.
Healthcare providers are left in the lurch, forced to choose between risking patient safety and the logistical nightmare of replacing essential equipment on the fly. Hospitals must now train staff on complex new procedures, monitor for errors, and pray that a misloaded administration set doesn’t cost another life. Meanwhile, the people at the top—Baxter executives and FDA officials—face little consequence beyond a few tough questions and maybe a blip in quarterly earnings.
The Regulatory Merry-Go-Round: Bureaucracy Over Accountability
The FDA and Health Canada have both issued urgent safety alerts since mid-July, but their actions have stopped short of what common sense demands. Instead of taking the decisive step of pulling the Novum IQ pumps from circulation, they settled for a Class I recall that doesn’t require device removal. Hospitals are told to follow new guidelines, switch to alternatives “when possible,” and hope that nothing goes wrong during the next high-stakes infusion. This is not the first time we’ve seen this play out—previous recalls of similar devices from other manufacturers have followed the same script, with regulators ultimately siding with industry over patients.
The consequences are staggering: increased operational chaos in hospitals, higher risk of tragic errors, and a growing sense of distrust in both the medical device industry and the agencies that are supposed to keep us safe. If two deaths and dozens of severe injuries aren’t enough to force action, what is? The message here is clear: in the modern regulatory state, accountability is optional if your product is “too big to fail.”