HeartMate II LVAD and LVAS (2017-03-29)

Starting date:

March 29, 2017

Posting date:

April 21, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-63068

• 
  Reason
• 
  Affected products

Affected Products

1. HeartMate II LVAD -Implant Kit
2. HeartMate II LVAS-System Controller

Reason

As follow-up to the most recent communication in September 2015, we are advising Health Canada that Thoratec Corporation, acquired by Abbott Laboratories, is updating its alert guides, conducting a software upgrade and adding controller alignment markings for the Heartmate II System controller as part of a continued effort to ensure patients are successfully able to exchange their pocket controller in emergency situations.

The current updates include:

• Updated labeling and alarm guides, which will be provided by an Abbott representative and included with the system controller packaging.
• A software upgrade that simplifies the system controller alarm messaging by removing some advisory alerts on the patient's system controller. These are non-critical alerts that will be seen by clinicians on the system monitor when patients come in for their next appointment. Removing these advisory alerts from the system controller will further reduce the chance that a patient will react to such an alert by attempting to change system controllers unnecessarily.
• Enhanced connector alignment markings on the system controller and the LVAD's driveline connector to provide clearer aids in aligning the connectors during insertion/removal.
• The system controller with new yellow markings will be provided to all new patients and those current patients with a replacement of the system controller.
• Some existing patients will need to have their controller replaced (i.e. damaged or old model controller). In these cases, we will replace the controller at no cost, however in such a case, the patient's implanted driveline will not be changing and will not have matching yellow markings.

Affected products