Thoratec LVAD Recall Gets Class I Status

The FDA on Tuesday issued a Class I recall designation over Thoratec's advisory involving four patient deaths related to its HeartMate II left ventricular assist device (LVAD).

The issue actually has nothing to do with the LVAD itself, but rather is related to patients and caregivers who were unable to understand instructions and lacked the training needed to hook up a back-up system controller in cases of device alarm or malfunction.Besides resulting in four deaths, such difficulties also caused lost consciousness or reduced blood flow for five other patients, according to Pleasanton, CA-based Thoratec and the FDA.The FDA elaborates on what happened:

Thoratec sent an "Urgent Medical Device Correction" letter by email to all affected customers in early March. The company is updating labeling and training materials for the HeartMate II LVAS Pocket System Controller and has been urging physicians, caregivers and patients to get up to speed on the new instructions and training.Thoratec isn't the only company experiencing potentially deadly issues around device instructions. The FDA has also been warning that a Greatbatch Medical Orthopedic surgical tool could cause serious injury or death because it came with inadequate sterilization recommendations.

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