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FDA Sends Warning To Catheter Tip Manufacturer

Added September 28th, 2006

The US Food and Drugs Administration has sent out a warning letter to the manufacturer of catheter tips, which are used as a means of pumping drugs into the body. The warning was sent out due to problems with the devices, which in the past were highlighted by the FDA.

The warning letter sent by the FDA was issued to the Fridley based company, Medtronic Inc. The company manufactures a catheter tip made from platinum iridium, which is used with the catheter in order to get drugs into the body through the spinal fluid.

However, the FDA questioned the quality and design of the devices in its warning letter, and highlighted problems and cases where the tip had actually detached itself inside the body of patients.

The FDA also stated on its website that Medtronic had already failed to comply with standards on a number of occasions, and the warning letter went out to the company on 29th of August.

FDA Sends Warning To... | Printable Version (Opens In New Window)

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