CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath (2021-02-25)

Starting date:

February 25, 2021

Posting date:

March 18, 2021

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-75143

Last updated:
2021-03-18

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  Reason
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  Affected products

Affected Products

CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath

Reason

Initial field experience has shown a higher than anticipated number of complaints where the hemostatic valve dislodged while introducing the dilator or devices into the VIZIGO sheath. With a dislodged hemostatic valve, there is a potential loss of hemostasis that would be expected to result in minor bleeding. In an extremely rare circumstance, entrainment of air could lead to air embolism.

Affected products