Edwards Lifesciences recalls specific EZ Glide aortic cannula models due to potential separation during cardiopulmonary bypass, risking significant blood loss. Affected units have unique identifiers and lot numbers.
Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circuit during cardiopulmonary bypass which could result in significant blood loss.
Edwards Lifesciences is recalling certain EZ Glide aortic cannulas that may separate from their connectors during heart surgery, potentially causing serious blood loss. Patients using these devices should contact the manufacturer for details on affected units and next steps.
The cannula may detach from its connector during heart surgery, which could break the circuit needed for blood flow. This separation might cause uncontrolled bleeding and significant blood loss in the patient.
Healthcare professionals using the recalled cannulas for heart surgery procedures are most at risk. Patients undergoing cardiopulmonary bypass surgery with these specific models could experience significant blood loss if the cannula separates.
Check for the product's unique identifier (UDI) codes listed in the recall notice, such as EZC21A (00690103174182) or EZS24A (00690103172119). Also look for the specific lot numbers provided in the recall record.
Review the unique identifier (UDI) codes and lot numbers listed in the recall notice to determine if your device is affected.
Reach out to Edwards Lifesciences directly for guidance on next steps if your device is confirmed affected.
The recall is due to a potential risk that the cannula may separate from its connector during heart surgery, which could cause significant blood loss.
Check the unique identifier (UDI) codes and lot numbers listed in the recall notice to see if your device is affected. Then contact Edwards Lifesciences for further instructions.
Yes, the separation could lead to significant blood loss during surgery, which is a serious medical risk.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0420-2020 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-0420-2020 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.
