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