CanadaAbbott Medical is notifying users of the CentriMag™ Blood Pump (model 201-90016; affected lot/serial numbers: more than 10 digits, contact manufacturer) and CentriMag™ Adult ECMO Kit (model CMAEK01) in Canada. Abbott reminds users to ensure the blood pump is securely locked into the CentriMag motor per the instructions for use because failure to lock the pump could lead to particulate or increased heat; Abbott is not requesting product return and says a pump that locks and is seated per the IFU is safe for use. Contact the manufacturer for additional information.
What's being recalled
Companies: Abbott Medical, 6035 Stoneridge Drive, Pleasanton, California, United States, 94588.
How to identify it
Affected products: CentriMag™ Blood Pump; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 201-90016
Affected products: CentriMag™ Adult ECMO Kit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: CMAEK01
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States