QuickDraw 22 & 25 Venous Cannula (2019-12-17)

Starting date:

December 17, 2019

Posting date:

January 10, 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-72075

Last updated: 2020-01-10

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  Reason
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  Affected products

Affected Products

1. QuickDraw 22 Venous Cannula
2. QuickDraw 25 Venous Cannula

Reason

Edwards Lifesciences has identified a potential safety risk that may occur during the use of QuickDraw Venous Cannula models QD22 and QD25 when used in an unintended manner. The QuickDraw Cannula is not designed, tested, or intended for use beyond 6 hours. When the cannula is used for longer than 6 hours, particularly during ECMO procedures and the associated patient movement during ECMO, there is a risk that separation of the cannula from its connector can occur; which can result in significant blood loss.

Affected products