Edward Lifesciences recalls Swan-Ganz Combo V catheters with possible monitor error messages due to bent distal ends. Affected units have specific model and lot numbers.
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 Lifesc: Sciences is recalling Swan-Ganz Combo V catheters that may bend beyond their intended shape, causing patient monitors to show errors. This could lead to incorrect readings during medical monitoring.
The catheter's distal end may bend too far when connected to patient monitors, causing the monitor to display an error message. This could lead to incorrect readings during critical medical monitoring.
Healthcare professionals using the specific catheter model for patient monitoring. Patients receiving this monitoring are at risk if the catheter bends.
Check for the model number REF 774F75 on the catheter's packaging or label. The catheter has an exterior diameter of 7.5F (2.5mm) and a usable length of 110 cm.
Look for the model number REF 774F75 on the catheter's packaging or label.
The catheter may bend beyond its intended curvature, causing patient monitors to display error messages.
The recall record does not specify a remedy, so contact Edwards Lifesciences for guidance.
The recall indicates a potential for monitor errors, but the risk is low as it does not cause immediate injury.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1380-2023 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-1380-2023 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.
