Heartware Ventricular Assist System - HVAD Implant Kit (2020-04-06)

Starting date:

April 6, 2020

Posting date:

May 15, 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-73077

Last updated: 2020-05-15

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  Reason
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  Affected products

Affected Products

Heartware Ventricular Assist System - HVAD Implant Kit

Reason

The outflow graft may be subject to tears and the strain relief screw may break during the pre-implant pump assembly and attachment to the HVAD pump. Manufacturer is providing additional steps for assembly and attachment to reduce the risk of damage and tearing during the assembly procedure. No action is needed for patients currently implanted with an HVAD pump since the potential for damage applies to the pre-implant outflow graft and strain relief assembly procedure.

Affected products