Health product recall

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

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

ENVEO PRO DELIVERY CATHETER SYSTEM

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

ENVPRO-14
ENVPRO-16

Companies
Manufacturer
MEDTRONIC COREVALVE LLC
1851 East Deere Avenue
Santa Ana
92705
California
UNITED STATES