Heartware inc. is recalling hvad pumps
The attorneys at TheLawFirm.com have been made aware that HeartWare Inc. is recalling 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.
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 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.
If you have such a unit, be sure to talk to your doctor right away. 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
• 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
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