HeartWare International Inc. (HTWR) announced a partial recall
of some of its waterproof heartpump controllers that may have
reduced speaker-volume levels owing to excess air vacuum in some of
the units.
The medical-device maker said a July design revision led to the
excess air vacuum during air transports. Though the company
expanded its product-testing in December of last year to screen out
affected units and added a small Teflon vent to prevent the
problem.
The controllers are part of the HeartWare Left Ventricular
Assist Systems, or heartpumps to treat advanced heart failure,
which is limited to investigational use in the U.S. The device is
available for commercial use in Europe.
President and Chief Executive Doug Godshall said, "There are
still patients being supported by our now waterproof controllers
that do not have the current 'vented' controller. This field
program will enable these older versions to be upgraded to the
current vented configuration." HeartWare will also replace some
other controllers.
The company said the reduced volume doesn't otherwise impede the
controllers' operation and that it has "significant inventory" of
vented controllers and associated components to repair and replace
the units without disruptions. The expected cost is less than
$400,000, the company said.
Shares closed Friday at $49.92 and were inactive premarket. The
stock is up 41% this year.
-By Tess Stynes, Dow Jones Newswires; 212-416-2481; Tess.Stynes@dowjones.com