HeartWare Issues Class I Recall of Older VAD Controllers

March 02, 2015

FRAMINGHAM, MA — HeartWare International, the maker of ventricular assist devices (VADs), issued a class I recall of older ventricular assist system controllers[1]. The external controllers, which power and monitor the HeartWare VADs, are at risk of electrostatic discharge that could cause the pump to stop and result in serious injury or death.

The HeartWare controllers are older models—product codes 1400 and 1401XX—distributed to patients as part of the ADVANCE and ENDURANCE clinical trials (serial numbers CON000001 through CON005472). As a result, the controllers in question were issued to patients prior to the US Food and Drug Administration (FDA) 2012 approval of the ventricular assist system as bridge therapy for patients awaiting heart transplantation.

The recall is estimated to affect 120 patients in the US.

"Since HeartWare has made design enhancements to the newer, commercial controllers to improve immunity to [electrostatic discharge], this recall does not affect newer commercial controllers," according to the company.

The class I recall is an expansion of a "field-safety corrective action" issued in 2013 warning physicians to monitor the performance of the controllers given their potential for electrostatic discharge. Since the 2013 notice, the company received reports of one additional death and one serious injury where electrostatic discharge might have caused the pump to stop.

In 2014, HeartWare was cited by the FDA for failing to take appropriate measures needed to correct design defects related to 27 complaints of controller failure over a 3-year period. As reported by heartwire , the FDA said the company did take corrective steps to deal with these complaints but failed to verify or validate the effectiveness of the corrective measures.

With the class I recall, clinicians should identify patients with recalled units, review the potential risks with the patient, and, if medically advisable, exchange the recalled controllers under medical supervision with a new one (those with serial numbers CON005473 or higher), according to HeartWare.


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