Heartmate 3 LVAS Implant Kit and Modular Cable With Cap (2019-12-03)

Starting date:

December 3, 2019

Posting date:

January 24, 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-72185

Last updated: 2020-01-24

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  Reason
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  Affected products

Affected Products

1. Heartmate 3 LVAS Implant Kit
2. Heartmate 3 Modular Cable With Cap

Reason

Reports received of the HeartMate 3 modular cable being incorrectly inserted into the controller by patients during controller exchange. If the modular cable is incorrectly inserted at 180 degrees from the proper orientation, there is potential for erroneous electrical contact to be made, which may cause a blown fuse, confusion for the patient, and the controller to alarm with " controller fault". In this case, although a physical connection appears to have been made, there is no electrical connection to the power pump.

Affected products