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Health product recall

HEARTWARE VENTRICULAR ASSIST SYSTEM - HEARTWARE BATTERY (2016-01-07)

Starting date:
January 7, 2016
Posting date:
January 18, 2016
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-56672

Affected Products

A. HEARTWARE VENTRICULAR ASSIST SYSTEM - HEARTWARE BATTERY

Reason

Batteries produced within the serial number ranges BAT000001 to BAT199999 appear more likely to exhibit premature or unrecognized deterioration of battery capacity.

Affected products

A. HEARTWARE VENTRICULAR ASSIST SYSTEM - HEARTWARE BATTERY

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

1650DE

Companies
Manufacturer
Heartware Inc.
14400 NW 60th Avenue
Miami Lakes
33014
Florida
UNITED STATES