HEARTWARE VENTRICULAR ASSIST SYSTEM - HVAD IMPLANT KIT (2021-06-03)

Starting date:
June 3, 2021
Posting date:
June 9, 2021
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-75771

Last updated:

Affected Products 

HEARTWARE VENTRICULAR ASSIST SYSTEM

Reason

Medtronic is issuing a global communication announcing decision to stop the distribution and sale of the Heartware Ventricular Assist Device (HVAD) System. Physicians should immediately stop new implants of the Medtronic HVAD System. Prophylactic explant of the HVAD System is not recommended at this time. A growing body of observational clinical comparisons demonstrate a higher frequency of neurological adverse events and mortality with the HVAD™ System as compared to other commercially available durable Left Ventricular Assist Devices (LVAD). Considering these findings and given the availability of alternative devices such as the Abbott HeartMate™ 3, Medtronic has made the decision to stop the distribution and sale of the HVAD System. Medtronic advises that there be no further implantations of the HVAD System. In addition, in December 2020, Medtronic issued an urgent medical device communication informing physicians of an issue where the HVAD pump may experience a delay to restart or a failure to restart. The communication explained that a subset of HVAD devices included an internal pump component from three (3) specific lots that increased the risk of restart failure. Although Medtronic has identified the root cause and mitigations for pumps within the 3 specific lots, they have not been able to pinpoint a root cause for the other restart failures reported with the HVAD pumps.

Affected products

HEARTWARE VENTRICULAR ASSIST SYSTEM

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

1104

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