Wednesday, 19 July 2017 11:45

Dutch Authorities Recall Heartmate II Lvas Pocket System Controller

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The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed that the Dutch Food and Consumer Product Safety Authority on 30th May, 2017, recalled Heartmate II LVAS Pocket System Controller due to risk of patient injury and/or death during backup controller exchange.

The Heartmate II LVAS 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. The Heartmate II LVAS System is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.The pocket System controller is provided to each patient for use in case of a device alarm or malfunction. Change to backup system controller should be done quickly and in the hospital to avoid risk of serious injury or death.

The details of the product are as follows:

Heartmate II Left Venticular Assist (LVAS) Pocket System Controller

Model/Item Numbers:           105109, 106015, 106762, 107801

Manufacturing Dates:             July 2012 to March 2017

Distribution Dates:                 July 2012 to March 2017

A total of 70 reports of incidents in which the controller has malfunctioned after an exchange including nineteen (19) injuries and twenty-six (26) deaths have so far been received by the manufacturer. All the deaths occurred when the patients attempted to exchange controllers while away from the hospital.

 Healthcare provider’s action

  • Healthcare providers treating patients with left ventricular heart failure using the Heartmate II LVAS Pocket system Controller should be aware of this risk and also communicate the same to their patients with Heartmate II LVAS System Controller. This will help prevent health risks associated with the use of the device.
  • Healthcare providers and patients should report adverse events associated with the use of this system to the nearest NAFDAC office, NAFADC PRASCOR (20543 TOLL FREE from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

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Read 1989 times Last modified on Wednesday, 19 July 2017 11:59

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