Heartmate 3 LVAS Implant Kit (2019-12-02)

Starting date:

December 2, 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-72187

Last updated: 2020-01-24

• Reason
• Affected products

Affected Products

Heartmate 3 LVAS Implant Kit

Reason

Abbott is informing customers that we have received reports of power loss to patients' HeartMate mobile power unit (mpu) module due to static electricity. When the HeartMate MPU module is connected to the HeartMate 3 left ventricular assist system (LVAS) excessive static electricity can potentially cause unrecoverable power loss and damage to the MPU module.

Affected products