FDA Issues Class I Recall and HeartWare Issues Reminder About Driveline Connector Device Correction

No doubt timed to coincide with the FDA’s Class I recall notice, HeartWare International, Inc. has itself issued a clinician and patient reminder concerning last December’s Urgent Medical Device Correction relating to its Ventricular Assist System.

Background

The device correction discussed eight complaints that the locking mechanism of the driveline connector of the HeartWare® Ventricular Assist System had failed to engage and instructed clinicians to inspect patient driveline connectors. To ensure full awareness, the company is in the process of redistributing this information to clinicians and patients.

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 November 2013 incorporate changes in manufacturing procedures which address this issue.

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 December 2013 correction following eight reported events in which the locking mechanism failed to engage. Four of these eight cases resulted in a temporary pump stop; however, none resulted in patient injury.

HeartWare’s reminder directs patients to discuss the correction notice with their physician or VAD Coordinator. For their part, 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 are instructed to promptly call their HeartWare representative to arrange a permanent repair.

Source: HeartWare International, Inc., PR Newswire, FDA

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