FDA classifies Medtronic heart pump recall as Class I

The FDA has classified Medtronic's recall of its HeartWare HVAD ventricular assist devices as Class I, the most serious type, Medtech Dive reported. The HeartWare HVAD ventricular assist devices were only distributed outside of the U.S. and there are no affected devices within the U.S.

The recall, which Medtronic initiated in January and that is linked to 36 complaints and a patient death, affects 5,489 of the devices. 

The HeartWare HVAD devices are pumps that help the left ventricle get blood around the body when it can't function independently, according to MedTech Dive. It is used in end-stage heart failure patients. 

The FDA said the design of the device creates the potential for users to insert the battery charger adapter into the wrong port, which could then damage the communication circuits in the controller regulating the pump from outside the body and stop the pump from working correctly. 

As of mid-January, Medtronic had received 36 complaints, and it said one patient died due to complications from the design issue. The FDA hasn't provided updated numbers since then, according to MedTech Dive. 

Read the full article here.

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