HeartWare warns on HVAD heart pumps

February 8, 2013 by MassDevice staff

HeartWare tells cardiac surgeons to inspect a component of its HVAD heart pump that's failed in a small number of patients.

HeartWare International

HeartWare International (NSDQ:HTWR) said it's issuing a "field correction" to cardiac surgeons, advising them to check a component of its HVAD implanted heart pump that's been reported to fail in less than 0.004% of some 2,900 implants.

The Framingham, Mass.-based company said the rear portion of the left ventricular assist device's driveline connector housing became partially or fully separated from the front of the driveline connector after extended use in 11 of 2,900 cases.

"In the unlikely event of a separation, a repair may be necessary. If left unattended, electrical connection to the controller could be affected and a VAD stop alarm could result. None of the confirmed events have resulted in harm to the patient," according to a press release. "In the event of a separation, hand-tightening of the connector housing may be sufficient as a temporary measure; however, healthcare professionals are instructed to contact HeartWare to arrange for an inspection and permanent repair by a HeartWare clinical engineer. No product replacement or exchange is required."

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HeartWare said it's in the process of changing its manufacture of the device to prevent future occurrences. The action is not expected to have much of an effect on HeartWare's finances, according to the release.

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