ICU Medical recalls hemodynamic monitoring systems with Patient Interface Module (58401-000) and User Interface Module (58403-000) that may continue thermal coil activity when paused, potentially causing overheating.
When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pause mode, the catheter thermal coil may continue while in pause mode.
ICU Medical is recalling hemodynamic monitoring systems that include a Patient Interface Module (Part Number 58401-000) and User Interface Module (Part Number 58403-000). When the system is paused during continuous cardiac output monitoring with a pulmonary artery catheter, the thermal coil may continue operating, which could lead to overheating.
When the system is paused during continuous cardiac output monitoring with a pulmonary artery catheter, the thermal coil may continue operating. This could cause overheating of the catheter, potentially leading to tissue damage or injury.
Healthcare professionals using the hemodynamic monitoring system in hospitals for cardiac output monitoring. Patients receiving continuous cardiac output monitoring with pulmonary artery catheters are at risk if the system is paused.
Check for Patient Interface Module (Part Number 58401-000) and User Interface Module (Part Number 58403-000) with specific serial numbers listed in the recall notice. The system is intended for hospital use in cardiac monitoring.
Identify the Patient Interface Module (Part Number 58401-000) and User Interface Module (Part Number 58403-000) with the serial numbers listed in the recall notice.
When the system is paused during continuous cardiac output monitoring with a pulmonary artery catheter, the thermal coil may continue operating, potentially causing overheating.
Check for Patient Interface Module (Part Number 58401-000) and User Interface Module (Part Number 58403-000) with the specific serial numbers listed in the recall notice.
The recall notice does not specify a remedy or action for affected products.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1775-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1775-2018 from ICU Medical. 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.
