HeartWare recalls some HVAD implantable heart pumps on electrical fault risk

HeartWare International (NSDQ:HTWR) this week recalled some of its HVAD implantable heart pumps on the risk of electrical faults from driveline contamination.

The recall affects an unspecified number of the left ventricular assist devices, according to an August 15 letter the Framingham, Mass.-based company sent to physicians who implant the pump. Connector contamination of the driveline most often occurred in the 1st 30 days, according to HeartWare, which agreed in June to a $1.1 billion acquisition by Medtronic (NYSE:MDT).

“Specifically, foreign material at the driveline/controller connector could lead to electrical faults and connection failures. In these scenarios, potential risks include interruption of circulatory support due to a pump stop, which could cause serious injury or death,” the company said.

A driveline cleaning procedure, performed by HeartWare personnel, is indicated for patients who experience electrical faults from the driveline contamination. Devices subject to the recall that have already been implanted do not need to be explanted, HeartWare said.

Unused HVADs subject to the recall should be quarantined and returned to HeartWare. The recall affects HVADs with serial numbers prior to HW25838, according to the letter.

Last month, HeartWare reported 2nd-quarter results that blew away expectations on Wall Street. The company posted losses of -$10.9 million, or -62¢ per share, on sales of $68.7 million; adjusted to exclude 1-time items, losses per share were -43¢.

That’s less than half the consensus forecast on The Street, where analysts were looking for losses of -82¢ per share on sales of $57.4 million. The numbers represent a -60.3% reduction of red ink, despite a -6.8% top-line performance, compared with Q2 2015.

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