HeartWare warns of problems with product
Framingham-based HeartWare International reissued a warning Thursday regarding serious issues with its Ventricular Assist System, which aids people with advanced stage heart failure.
The company said it has received eight complaints of failed locking mechanisms in the patient driveline connection, which connect the device to an external controller used to power and monitor the device.
Four of those cases resulted in a temporary pump story, which HeartWare said “could cause serious injury or death.” However, none of the patients were actually injured, the company said.
HeartWare asked doctors to inspect the driveline connectors at the time of implant and at each routine clinic visit to make sure the connection remains secure.
The problem affects devices manufactured prior to November 2013, at which point the company changed its manufacturing procedures to address the issue.
(Image credit: freedigitalphotos.net)
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