UPDATED 02/27/2015. Recall classified as Class I.
AUDIENCE: Cardiology, Risk Manager, Patient
ISSUE: HeartWare International issued a voluntary Urgent Medical Device Recall in the United States related to older HeartWare Ventricular Assist System Controllers, which were distributed in the U.S. during the clinical trial period prior to Food and Drug Administration (FDA) approval in 2012. The company advises that affected clinical trial controllers exhibit a higher susceptibility to electrostatic discharge (ESD) than newer, commercial controllers. An ESD event could result in a pump stop, which could cause serious injury or death. Since HeartWare has made design enhancements to the newer, commercial controllers to improve immunity to ESD, this recall does not affect newer, commercial controllers.
This recall of HeartWare controllers (product codes 1400 and 1401XX) distributed during the ADVANCE and ENDURANCE clinical trial periods with Serial Numbers CON000001 through CON005472 is an expansion of HeartWare’s voluntary Field Safety Corrective Action, FSCA APR2013. HeartWare estimates the recall will impact approximately 120 patients in the U.S.
Since the 2013 Notice, HeartWare has received reports of one additional death and one additional serious injury in which ESD may have caused or contributed to a pump stop.
BACKGROUND: HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat patients suffering from advanced heart failure.
RECOMMENDATION: Clinicians are being asked to identify patients with recalled controllers, review the applicable risks with the patient and, if medically advisable, exchange the recalled controllers under medical supervision with a new controller (serial number CON005473 or higher). It is the treating physician’s responsibility to assess a patient’s status and determine if the related risks are acceptable. Patients should not attempt to exchange recalled controllers, as controller exchanges may not be suitable for all patients. It is recommended that exchanges of recalled controllers be performed in a controlled setting under medical supervision.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178