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|HeartWare Issues Reminder To December 2013 Driveline Connector Device Correction|
Impacted HeartWare Systems carry catalog numbers: 1100, 1101, 1102, 1103, 1104, and 1205 with serial numbers ranging from: HW001 to HW11270 and HW20001 to HW20296. All devices manufactured since
A disconnected driveline would result in a temporary pump stop which could cause serious injury or death, depending on the function of a patient's native heart. HeartWare issued the
Patients are requested to discuss the correction notice with their physician or VAD Coordinator. Clinicians are asked to inspect the patient's driveline connector for proper locking at implant and at each routine clinic visit to ensure that the connector assembly remains secure. Should the locking mechanism fail to engage or the driveline disconnects from the controller, the driveline connector should be pushed back into the controller immediately. Clinicians should promptly call their
Patients with questions about this announcement should contact their physician or VAD Coordinator at their hospital center. Clinicians with questions related to this announcement or who wish to schedule a driveline connector repair should contact HeartWare Clinical Support at (888) 494-6365 or via email at FSCA@heartware.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the
Investor and media contact: