Recall MonitorHealth Products
MEDRAD® Centargo Injection System
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: MEDRAD® Centargo Injection System
Issue: Medical devices - Performance
What to do: Customers will be notified with instructions to follow.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| MEDRAD® Centargo Injection System | Contact the manufacturer. | CENT-SYS-BAT |
Issue
Centargo patient line sensor is a component of the Centargo injection system which detects a patient line. An investigation into reported air injection concerns found that, under certain special conditions, the patient line sensor may occasionally have difficulty detecting the presence of the patient line. This intermittent detection issue, combined with user reliance on automated system functions (such as auto-prime) and possible workflow inconsistencies, may slightly increase the likelihood of small air injections (1-10 ml). However, the overall risk remains low. Recall start date: December 13, 2024