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Insightra Warned for Administrative Problems

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Brian Hendricks2 years ago

According to MassDevice, Insightra Medical has received an official warning from the U.S. Food and Drug Administration (FDA). The warning came after federal investigators found that Insightra was having problems “reporting and investigating failure complaints”.

These complaints were filed in reference to Insightra’s intra-aortic balloon catheters.

Information about the Catheters

There have been several reports of the intra-aortic balloon catheters failing. In fact, one death has been reported in relation to the faulty catheters.

When the death was reported to Insightra, the medical company failed to retrieve and examine the faulty device.

About the FDA Warning

In February, an FDA investigator visited Insightra’s headquarters in Irvine, California. Upon inspection of the facility, investigators issued a warning that outlined the company’s failure to receive, review, and evaluate complaints in a timely and organized manner.

12 specific customer complaints were mentioned in the FDA’s report. Four of these complaints were not adequately investigated by Insightra. The investigations that the company ought to have performed would have identified and reported the cause of the catheter’s failure.

In addition, Insightra failed to contact the individuals that filed the complaints, which is standard procedure in the event of a device failure.


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