Edward Lifesciences recalls Swan-Ganz Combo V catheters with possible bent distal ends causing monitor errors. Affected units have specific lot numbers and exterior diameter 8F.
There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.
Edward Lifesciences is recalling Swan-Ganz Combo V catheters that may bend beyond their intended shape, potentially causing patient monitoring devices to display errors. This could lead to incorrect readings during critical medical procedures.
The catheter's distal end may bend beyond its intended curvature when connected to patient monitoring devices. This can cause the monitor to display an error message, potentially leading to incorrect readings during critical medical procedures.
Healthcare professionals using the Swan-Ganz Combo V catheter for cardiac monitoring are most at risk. Patients receiving this device during procedures may be affected if the catheter bends.
Check for the product name 'Swan-Ganz Combo V', exterior diameter 8F, and lot numbers listed in the recall (e.g., 64191420, 64228620).
Verify the product name and exterior diameter (8F) to confirm if it matches the recalled items.
Reach out to Edwards Lifesciences directly for specific guidance on the affected lot numbers.
The recall is due to a potential bend in the catheter's distal end that may cause patient monitoring devices to display error messages.
Check for the product name 'Swan-Ganz Combo V', exterior diameter 8F, and lot numbers listed in the recall (e.g., 64191420, 64228620).
Contact Edwards Lifesciences directly for specific guidance on the affected lot numbers and next steps.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1379-2023 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-1379-2023 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.
