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FDA Places Most Serious Recall Label on Medtronic Heartware HVAD Issue

Oct 24, 2016
FDA Places Most Serious Recall Label on Medtronic HVAD

Medtronic Heartware HVAD Recalls Issue

Heartware, a subsidiary of Medtronic, has recalled its Heartware Ventricular Assist Device (HVAD) due to problems with its driveline connector tubes. The issue can cause the pump to stop working. The device is implanted in patients at risk of death from end-stage left ventricular heart failure or patients awaiting a heart transplant. HVAD helps deliver blood from the heart to the rest of the body.

The FDA placed its most serious "Class 1" label on the HVAD recall. Class 1 recalls indicate that exposure to the recalled device presents a reasonable risk of serious injury or death.

The HVAD pump is connected to the external controller and power source via driveline connectors. The recall is being issued because a design defect with some driveline connectors causes fluid or other material to enter the pump. According to the FDA, the pump can stop working if this occurs.

The recall affects all HVAD devices with serial numbers lower than HW25838 with product codes 1103 and 1104 manufactured between March 17, 2006 and June 27, 2016. In the United States, 105 units are affected.

Medtronic Warns Rechargers Error State

Medtronic also recently warned that some rechargers used for its deep brain stimulation devices may be subject to an error state, where the recharger does not respond or supply charge until reset. Neurostimulators are implanted in patients with neurological disorders; for example, they are used to control movement symptoms associated with Parkinson's and epilepsy. Medtronic said that if the neurostimulator is not charged, patients may experience a return of symptoms. In rare cases, this can lead to life-threatening injury and death. Medtronic instructed customers to plug the rechargers into an AC power supply before recharging and keep them connected until charging is complete. Health care professionals can help patients reset the recharger if it is unresponsive.

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