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Health product recall

Driveline Splice Repair Kit (2015-05-04)

Starting date:
May 4, 2015
Posting date:
May 26, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-53507

Recalled Products

A. Driveline Splice Repair Kit

Reason

The possibility of retraction of connector pins within the driveline splice assembly following a splice repair was identified. The retraction of the of the splice assembly connector pins may be the result of excessive force to the driveline from accidental dropping of controllers or snagging of drivelines on items such as door handles or other hazards.

Affected products

A. Driveline Splice Repair Kit

Lot or serial number

480786 through 880816

Model or catalog number
  • ASY00116
  • ASY00281
Companies
Manufacturer

Heartware Inc.

14400 NW 60th Avenue

Miami Lakes

33014

Florida

UNITED STATES