Recall MonitorHealth Products
CentriMag™ Adult ECMO Kit and Blood Pump
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular, Health products - Medical devices - Gastroenterology and urology
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
Recall class: Type II
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.