HEARTWARE VENTRICULAR ASSIST SYSTEM - HVAD IMPLANT KIT (2020-12-08)

Starting date:

December 8, 2020

Posting date:

December 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-74647

Last updated: 2020-12-24

• Reason
• Affected products

Affected Products 

HEARTWARE VENTRICULAR ASSIST SYSTEM - HVAD IMPLANT KIT

Reason

Medtronic internal processes identified a potential quality signal with a component in a subset of HVAD Implant Kits. To support investigation of the issue, Medtronic is voluntarily retrieving non-implanted product for further engineering evaluation.

Affected products