[Posted 04/04/2012]

Audience: Cardiology, Risk Manager, Transplant

Issue: FDA is notifying health care professionals of a Class 1 Recall due to detachment of the bend relief from its intended position around the proximal outflow graft may allow the graft to kink or deform, resulting in reduction of blood flow from the HeartMate II LVAS pump, pump/graft thrombosis, or perforation of the outflow graft.  Additionally, the metal end of the bend relief may be sharp and cause erosion and cutting of the outflow graft.  This product may cause serious adverse health consequences, including death.  Model numbers affected: 103393, 103695, 104692, 104911, 104912.

Background: The HeartMate II LVAS is indicated for use as a bridge to transplantation in heart transplant candidates at risk of imminent death from non-reversible left ventricular failure.  It is also indicated for use in patients with New York Heart Association (NYHA) Class IIB of IV end-stage left-ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days and who are not candidates for heart transplantation. 

The HeartMate II blood pump delivers blood from the dysfunctional left ventricle of the heart to the rest of the body.  It is an axial-flow, rotary ventricular assist system and can generate blood flows up to 10 liters per minute (1 beat per minute).  The device is intended to be used both inside and outside the hospital (e.g., at home), or during transportation of ventricular assist device patients by ground ambulance, airplane or helicopter.

Recommendations: The device labeling has been revised to provide instructions on how to verify the bend relief is fully engaged with the sealed outflow graft at the time of implant and new caution statement regarding the bend relief connection are included.  Clinicians have been instructed to follow the revised instructions for use that clarify the recommended procedure for securing the bend relief to the outflow graft. 

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.htm
• 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

[04/04/2012 - Recall Notice - FDA]