FDA Advises To Not Use Getinge’s Heart Devices

FDA Advises To Not Use Getinge's Heart Devices

Heart disease is very common in the US. However, on Wednesday, the FDA made a special announcement on how healthcare facilities in the US should move away from using heart devices made by Getinge’s.

According to the US Food and Drug Administration, they have issued a statement about how it has been unsafe for heart patients. They also specified that it is low in quality and has not improved since the string of recalls.

You might be wondering why the FDA would make such a claim without any concrete evidence. However, the FDA has investigated that Getinge is not sufficiently addressing the problems and the risks that come with the heart devices. They even deny the fact that there could be anything wrong with their device.

However, after the accusations, Getinge did not respond and didn’t even call the press to falsify the claims.

The FDA also suggests that people move away from using Getinge’s Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump and its other cardiac devices.

Furthermore, the health regulator even recommends providers to transition away from these cardiovascular devices by Getinge’s and try its alternatives.

Getinge’s devices, specifically the Intra-Aortic balloon pump, have electrochemical systems that both inflate and deflate the balloons in such a way that the aorta only provides temporary support to the left ventricle.

There have been more than 10 voluntary recalls in the US about such cardiovascular devices. Among them 8 were classified to be extremely serious.

In the last year, the health regulator even received more than 2,900 medical device reports that talk about Getinge’s device and how it’s faulty. The health regulator also exclaimed that out of those reports, 15 patients either suffered a serious injury or lost their lives.

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Titas Ghosh Chaudhury
Titas is a lawyer with a penchant for writing. In her leisure hours she likes to read books and collect Pokemon plushies and stay updated with different law judgements.

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