HeartWare Ventricular Assist System - Battery Charger And AC Adapter (2020-01-28)
- Starting date:
- January 28, 2020
- Posting date:
- February 28, 2020
- 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-72427
Last updated: 2020-03-06
Affected Products
- HeartWare Ventricular Assist System - HeartWare Battery Charger
- HeartWare Ventricular Assist System - Battery Charger AC Adapter
Reason
Medtronic HeartWare is informing customers of the potential for an HVAD system user to mistakenly insert the battery charger AC adapter into an HVAD controller power port. When this occurs, communication circuits between the battery and the controller may be damaged. If circuit damage occurs, it will be necessary to exchange the controller to restore communication between the batteries and controller. Power to the controller and to the HeartWare HVAD pump will continue to be maintained if a battery charger AC adapter is mistakenly inserted into a controller power port and a secondary power source also is connected to the controller. The battery charger AC adapter is not intended to be attached to a controller power port.
If circuits within the controller are damaged as the result of this issue, it will be necessary to exchange the controller to restore controller-to-battery communications and resolve alarms. A controller exchange could lead to patient harm due to pump stoppage. Temporary pump stoppage could lead to exacerbation of heart failure symptoms and/or symptoms related to hypoperfusion ranging from mild weakness to dizziness, anxiety, nausea, lightheaded/loss of consciousness, or death. The severity of harm is dependent on the patient's cardiac status.
Affected products
A. HeartWare Ventricular Assist System - HeartWare Battery Charger
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
1610CA
Companies
- Manufacturer
-
Heartware Inc.
14400 NW 60th Avenue
Miami Lakes
33014
Florida
UNITED STATES
B. HeartWare Ventricular Assist System - Battery Charger AC Adapter
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
1640CA
Companies
- Manufacturer
-
Heartware Inc.
14400 NW 60th Avenue
Miami Lakes
33014
Florida
UNITED STATES