FDA MedWatch - HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc. : Class I Recall - Contamination Causing Electrical Issues

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc. : Class I Recall - Contamination Causing Electrical Issues

HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc. : Class I Recall - Contamination Causing Electrical Issues

 

AUDIENCE: Risk Manager, Nursing

ISSUE: HeartWare Inc. is recalling the HVAD pumps due to a design problem with the driveline connector. The driveline is a tube that connects the HVAD's pump to the external controller and power source. Contamination of the driveline may result in fluid or other material entering the pump and causing electrical issues or pump stops that may lead to serious adverse health consequences, including death.

BACKGROUND: The HVAD helps deliver blood from the heart to the rest of the body. It is used in patients who are at risk of death from end-stage left ventricular heart failure and who are waiting for a heart transplant. The system includes a pump implanted in the space around the heart (pericardium) and a controller that controls the speed and function of the pump. The HVAD is designed for use both in and out of hospital settings, including during patient transport. This recall affects all HVADs with serial numbers lower than HW25838, Product Codes 1103 and 1104, manufacturing dates: March 17, 2006 to June 27, 2016. 105 units have been recalled in the U.S.

RECOMMENDATION: On August 17, 2016, HeartWare Inc. sent an "Urgent Medical Device Recall Letter" to affected customers. The letter instructed consumers to:

• Identify affected HVADs in hospital inventory
• Complete and return the "Acknowledgement Form" attached to the letter
• Return affected products to HeartWare Inc.
• After returning the affected products, complete and return the "Completion Form" to a HeartWare representative no later than 2 months from the date on the letter
• Remind their patients about the safe use of the HVAD System, particularly with regard to moisture and proper connection to power and data sources.

Health care providers who have questions should contact their HeartWare representative or contact HeartWare Inc. at cs@xxxxxxxxxxxxx or 1-877-367-4823 with any questions related to this recall.

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

Read the MedWatch safety alert, including links to the Recall Notice, at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm526416.htm

 

 

 

 

 

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