Recall MonitorHealth Products
DLP Antegrade Aortic Root Cardioplegia Cannulae
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: DLP Antegrade Aortic Root Cardioplegia Cannulae
Issue: 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 catalog number |
|---|---|---|
| DLP Antegrade Aortic Root Cardioplegia Cannulae | More than 10 numbers, contact manufacturer. | 11012 11014 11014L 21014 11012L 21012 |
Issue
During the manufacturing process, unexpected loose plastic material in the male luer used in the aortic root cannula was identified. The potential harms when identified prior to use is procedure delay while another cannula is located. If this is not identified prior to use, and the clinician uses the cannula, the potential harm is stroke (reversible and irreversible). Recall Start Date: February 5, 2025