Tuesday, 17 January 2017 13:59

Recall Of Heartware Ventricular Assist Device (HVAD) Pumps

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The attention of the agency has been drawn to the recall of Heartware Ventricular Assist Device Pump (HVAD) by the Heartware Incorporate due to a design problem with the Driveline connector. The Driveline connector is a tube that connects the HVAD’s pump to the external controller and power source. The HVAD pump 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 those waiting for a heart transplant.

Reason for recall:

Contamination of the driveline may result in fluid or other materials entering the pump and causing electrical issues or pump stops that may lead to serious adverse health consequences including Death.

This recall affects all HVADs with serial numbers lower than HW25838, product codes 1103 and 1104, manufacturing dates are from March 17, 2006 to June 27, 2016, it has 105 units.

NAFDAC encourages healthcare professionals and patients to report adverse events or side effects related to the use of these products to NAFDAC PRASCOR (20543-Toll free from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC...... Safeguarding the health of the nation!!!

 

Read 1700 times Last modified on Tuesday, 17 January 2017 14:06

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