ENVEO PRO DELIVERY CATHETER SYSTEM (2021-06-09)

Starting date:

June 9, 2021

Posting date:

June 30, 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-75927

Last updated:
2021-06-30

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  Reason
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  Affected products

Affected Products

ENVEO PRO DELIVERY CATHETER SYSTEM

Reason

Medtronic is voluntarily recalling EnVeoR Pro Delivery Catheters with a manufacturing date before 11-Jul-2020. Medtronic is taking this action to reduce the potential for actuator separation within the subset. Actuator separation may occur during valve loading on the delivery system, advancement, deployment or recapture of the valve. Through March 2021, the reported rate of actuator separation on the original design version was 0.18% out of 270,071 sold worldwide. If the actuator separates during a procedure, it could lead to procedure delays, hypotension, secondary procedure, or tissue damage. The actuator is an external component of the handle of the Enveo Pro Delivery Catheters.

Affected products