Health product recall

CentriMag™ Adult ECMO Kit and Blood Pump

Brand(s)
Last updated

Summary

Product
CentriMag™ Adult ECMO Kit and Blood Pump
Issue
Medical devices - Device compatibility
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
CentriMag™ Blood Pump More than 10 numbers, contact manufacturer. 201-90016
CentriMag™ Adult ECMO Kit More than 10 numbers, contact manufacturer. CMAEK01

Issue

Abbott is initiating a voluntary recall customer notification to remind customers that when using the CentriMag™ Acute Circulatory Support System you must always ensure the CentriMag™ blood pump is securely locked into the CentriMag™ motor as described in the instructions for use (IFU). Failure to properly lock the blood pump into the motor could lead to particulate or increased heat while using the system. At this time, Abbott is not requesting that this product be returned or removed from the field. If the pump is able to be locked into the motor, the product is safe for use and functions as intended when the IFU is followed to securely seat the pump.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Health products - Medical devices - Gastroenterology and urology
Companies

Abbott Medical

6035 Stoneridge Drive, Pleasanton, California, United States, 94588

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-78349

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