HEARTWARE VENTRICULAR ASSIST SYSTEM (2021-03-04)

Starting date:

March 4, 2021

Posting date:

March 25, 2021

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-75201

Last updated:
2021-03-25

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  Reason
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  Affected products

Affected Products 

1. HEARTWARE VENTRICULAR ASSIST SYSTEM - HEARTWARE CONTROLLER
2. HEARTWARE VENTRICULAR ASSIST SYSTEM - HEARTWARE CONTROLLER AC ADAPTER
3. HEARTWARE VENTRICULAR ASSIST SYSTEM - HEARTWARE CONTROLLER DC ADAPTER CONTROLLER
4. HEARTWARE VENTRICULAR ASSIST SYSTEM - ALARM ADAPTER
5. HEARTWARE VENTRICULAR ASSIST SYSTEM - DATA CABLE
6. HEARTWARE VENTRICULAR ASSIST SYSTEM - HEARTWARE BATTERY

Reason

Medtronic is informing customers of an issue related to the Heartware HVAD Controller. Specifically, there is the potential for the Controller Power Cables (AC adapter, DC adapter, and battery cables), HVAD alarm adapter, and HVAD monitor data cables to cause damage to the HVAD Controller Ports when inserting the Cables into the Controller Ports, due to misalignment of the Cables to the port. Over time, repeated misalignment causes wear on the power Cables and Data Cables and may cause damage or bending on the Controller Port metal pins. This damage can result in the inability to fully lock the Cable Connectors into the Controller, potentially causing interruptions or disconnections in power to the Controller, which may result in Controller Power loss and HVAD pump stop or loss of communication to the HVAD monitor. When this occurs, it may be necessary to exchange the Controller to restore connections between the power sources and Controller.

To reduce the risk of damage to the HVAD Controller Power Cables and Data Cables that can be caused by the misalignment, Medtronic is providing more detailed instructions in an updated Instruction For Use (IFU) and Patient Manual (PM) about the criteria and frequency for inspecting the Cables and Controller Ports.

Affected products