Thoratec Corporation, HeartMate II LVAS Pocket System Controller – Insufficient Labeling and Training for Patients Switched from the EPC Controller
Recall Class: Class I
Date Recall Initiated: March 4, 2014
Product(s): HeartMate II Left Ventricular Assist (LVAS) Pocket System Controller
106015 and 106016 – HeartMate II LVAS Implant Kit with Pocket Controller
106762 and 106017 – HeartMate II LVAS Pocket System Controller
107801 – HeartMate II LVAD Pump and Pocket Controller Kit
105109 – Pocket System Controller removed from packaging
Distribution Dates: August 2012 – June 2014
Use: The Pocket System Controller is a power supply that connects to the implanted HeartMate II LVAS pump through a lead (driveline) under the skin. The controller helps power the LVAS system, a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. The controller is powered by batteries or connected to a main power supply.
A back-up system controller is provided for use in case of a device alarm or malfunction. Instructions and training are provided on how to switch from one system to the other.
6035 Stoneridge Drive
Pleasanton, CA 94588-3270
Reason for Recall:
Thoratec has received five reports of serious injury and four reports of death associated with difficulty in changing from the primary system controller to a back-up system controller. All reports were linked to patients whose HeartMate II LVAS device was originally attached to an older model of controller, the EPC System controller. When the Pocket System Controller became available, patients were switched from the EPC System Controller to the Pocket System Controller. However, these patients did not receive intensive training on connecting the new controller. The design differences between the EPC System Controller and the Pocket System Controller require a different approach to how the device is connected. If the controller is not properly connected, the device cannot function.
The use of this product may cause serious adverse health consequences, including death.
Individuals with questions regarding this recall may contact Thoratec Corporation at 800-528-2577 or 925-847-8600, 7 days per week, 8:00 AM – 5:00 PM, Pacific Time.
FDA District: San Francisco District Office
More Information about this Recall: On March 4, 2014, Thoratec Corporation sent an “Urgent Medical Device Correction” letter by email to all affected customers. Customers were requested to complete and sign an Acknowledgement Letter that was attached to the email and return it to Thoratec via FAX or scanned email copy.
The letter identified the product, problem and the actions to be taken:
- Physicians who prescribe the HeartMate II LVAS Pocket Controller should immediately review the updated labeling and training materials provided in the Urgent Medical Device Correction Letter with all clinical personnel responsible for training patients and caregivers on the use of the Pocket System Controller.
- All patients using the Pocket System Controller and their caregivers should be retrained on the use of the device and be provided with updated Patient Handbook information.
- Thoratec plans to update labeling and training materials for the device to provide better instruction on connecting the driveline to the Pocket System Controller.
About Class I Recalls
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.