Edwards Lifesciences recalls QuickDraw Venous Cannula models QD22 and QD25 due to risk of blood loss if used longer than 6 hours, especially during ECMO. Affected units have specific UDI numbers.
If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during extracorporeal membrane oxygenation [ECMO]) there is a risk that separation of the cannula from its connector can occur; which can result in significant blood loss.
Edwards Lifesciences is recalling two types of QuickDraw Venous Cannula (QD22 and QD25) because using them for more than 6 hours, particularly during ECMO treatment, can cause the cannula to detach from its connector and lead to significant blood loss.
If the venous cannula is used for longer than 6 hours, especially during ECMO (a life-support treatment), it can become detached from its connector. This detachment can cause significant blood loss, which is serious for patients undergoing such procedures.
Healthcare professionals using these cannulas for ECMO treatments or other venous access procedures are most at risk. Patients receiving ECMO care with these cannulas may also be affected.
Check for the product model numbers QD22 or QD25 on the cannula packaging or label. The unique device identifier (UDI) numbers 00690103182699 and 00690103182705 are also associated with these recalled items.
Identify if your cannula has model numbers QD22 or QD25 and UDI numbers 00690103182699 or 00690103182705.
The recall is due to a risk of blood loss if the venous cannula is used for longer than 6 hours, especially during ECMO treatments.
The official recall notice does not specify a remedy or action for affected products.
The product is safe for use up to 6 hours, but using it longer than that, especially during ECMO, can cause detachment and blood loss.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0800-2020 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-0800-2020 from Edwards Lifesciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
