Life Sciences

Thoratec initiates recall of heart device

Device Regulation Alert: Safety, Compliance and Reimbursement News, November 3, 2008

Thoratec issued a worldwide correction for some of its HeartMate II Left Ventricular Assist Systems, according to a press release.

Wear and fatigue to the percutaneous lead may result in damage that could interrupt pump function, require another operation to replace the pump, and potentially result in serious injury or death. Thoratec received 27 reports of wear leading to replacement of the device over five years of clinical experience with 1,972 implants.

The company recommends patients with the device ask their physicians to assess the amount of wear to the lead. Thoratic also sent a letter to hospitals identifying the probability and symptoms of the problem, and recommending the pump be replaced as soon as possible if damage to the percutaneous lead is confirmed.

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