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The FDA approved a tool to update the software on Tandem's pumps in July 2016. The Tandem Device Updater would be used to deliver all software updates to Tandem's pumps moving forward and that the first use of the new tool will be to update t:slim pumps which were shipped prior to April 2015 with a new version of the firmware which speeds the ...
In July 2023, the FDA issued a Class I recall for all Impella left-sided blood pumps due to risk of motor damage after contact with a transcatheter aortic valve replacement stent. [29] [30] In March 2024, the FDA issued a warning about Impella left-sided blood pumps being linked to 49 deaths due to left ventricular perforation or wall rupture ...
Any change in basal or bolus is patient-driven by programming the pump using the Bolus Wizard. The latest model pumps are the MiniMed Paradigm 522 and 722, which differ in reservoir size, 176 versus 300 units, respectively. In 2007 the FDA approved a pediatric model for patients 7 to 17 years old. [6]
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The recall by the U.S. Food and Drug Administration of one medical company's entire line of infusion pumps -- widely used to administer fluids to the human body -- has called attention to ...
The FDA approval was based on the PROTECT II randomized controlled trial, which found high-risk percutaneous coronary intervention (PCI) patients who underwent PCI with Impella had fewer major adverse events at 90 days (although statistically non-significant), compared to patients who underwent PCI with the intra-aortic balloon pump (IABP). [37]
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