Heartware Ventricular Assist System- Controller/ Controller Kits, AC Adapter, DC Adapter, and Battery Pack (2018-05-07)
- Starting date:
- May 7, 2018
- Posting date:
- June 1, 2018
- 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-66936
Affected products
A. Heartware Ventricular Assist System- Controller/ Controller Kits
B. Heartware Ventricular Assist System- AC Adapter
C. Heartware Ventricular Assist System- DC Adapter
D. Heartware Ventricular Assist System- Battery Pack
Reason
Manufacturer is providing this notification to inform customers of the potential for a transient interruption of the electrical connection between an HVAD system power source (battery, ac adapter, or dc adapter) and the HVAD controller that may result in unintended power switching to the secondary power source and/or unexpected audible tones ("beeping"). This interruption, which occurs while the power source remains physically connected, is due to oxidation of connecting surfaces between a power source connector and the controller's power source socket, and typically lasts 1-2 seconds.
Unexpected beeping occurs when the interruption automatically resolves and may cause confusion to the patient or caregiver, as the controller may display sufficient battery capacity or AC/DC connectivity at the time of the audible tone. A critical battery alarm may also be momentarily displayed due to this phenomenon.
Affected products
A. Heartware Ventricular Assist System- Controller/ Controller Kits
Lot or serial number
All lots.
Model or catalog number
1407CA
1420
Companies
- Manufacturer
-
Heartware Inc.
14400 NW 60th Avenue
Miami Lakes
33014
Florida
UNITED STATES
B. Heartware Ventricular Assist System- AC Adapter
Lot or serial number
All lots.
Model or catalog number
1430CA
Companies
- Manufacturer
-
Heartware Inc.
14400 NW 60th Avenue
Miami Lakes
33014
Florida
UNITED STATES
C. Heartware Ventricular Assist System- DC Adapter
Lot or serial number
All lots.
Model or catalog number
1440
Companies
- Manufacturer
-
Heartware Inc.
14400 NW 60th Avenue
Miami Lakes
33014
Florida
UNITED STATES
D. Heartware Ventricular Assist System- Battery Pack
Lot or serial number
All lots.
Model or catalog number
1650DE
Companies
- Manufacturer
-
Heartware Inc.
14400 NW 60th Avenue
Miami Lakes
33014
Florida
UNITED STATES