The FDA recently announced critical recalls on several widely used medical devices, including Life2000 ventilators, Medtronic's MiniMed insulin pumps and Boston Scientific's Obsidio conformable embolic device.
Here is more information on each recall:
- Baxter Healthcare Life2000 ventilator
Baxter Healthcare issued an urgent recall Oct. 24 for its Life2000 ventilators, advising users to connect the device to a gas source before starting therapy. The recall follows reports of low gas pressure failing, potentially leading to oxygen desaturation or shortness of breath. The FDA categorized this recall as the most serious type and stated that a software update is expected to fix the issue and that affected users have been contacted with instructions to ensure safe use until other updates are made available.
- Medtronic MiniMed
Medtronic recalled its MiniMed 600 and 700 series insulin pumps Oct. 24 due to reduced battery life that could cause insulin delivery to stop unexpectedly. If battery alerts go unheeded, the device may fail, potentially leading to hyperglycemia or diabetic ketoacidosis. The FDA advised users to carry extra batteries and replace them as soon as alerts are received. Medtronic has also provided a 24-hour support line to assist customers who face ongoing battery issues.
- Boston Scientific Obsidio Embolic device
Boston Scientific updated its instructions Oct. 18 for its Obsidio conformable embolic device, following reports of 15 serious injuries and four deaths linked to improper use in gastrointestinal embolization procedures. New instructions warn against using certain techniques that could cause off-target embolization, leading to severe complications, like ischemia.