FDA Announces Class I Recall of Heart Failure Support System
Medtronic’s recall of nearly 5,500 battery chargers for its HeartWare hemodynamic support system has been classified as Class I by the FDA.
The HeartWare device is designed to assist patients with advanced refractory left ventricular heart failure. The FDA said the company pulled 5,489 battery charger devices due to a confusing design.
The battery charger’s design could cause system users to mistakenly insert the charger’s AC adapter into the wrong power port, potentially damaging circuits between the battery and controller. The recall only applies to adapters distributed outside the U.S.