Edwards Lifesciences Recalls QuickDraw Venous Cannulas Due to Connector Separation Risk
Edwards Lifesciences is recalling QuickDraw Venous Cannulas because the device may separate from its connector if used for more than six hours, potentially causing significant blood loss.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant blood loss, which aligns with the rubric criteria for Severe severity (FDA Class II with significant injury reports or potential).
Plain-English summary
Edwards Lifesciences, LLC is recalling QuickDraw Venous Cannulas (REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705). The recall involves 27,168 units distributed across 38 U.S. states and numerous foreign countries. The agency classification for this recall is Class II.
The recall is being issued because the venous cannula may separate from its connector if used in an unintended manner, specifically for longer than six hours, particularly during extracorporeal membrane oxygenation (ECMO). This separation can result in significant blood loss.
Healthcare facilities and consumers should stop using the affected devices immediately. Edwards Lifesciences is the recalling firm responsible for managing the recall.
The recalled product
- Product
- QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Vascular Access
- Affected units
- 27,168
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
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