Use cautionMedical device recall · FDA · Published January 5, 2018
ICU Medical recalls Hemodynamic monitoring system with pause mode thermal coil issue
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.
Take action
Contact the company
📍Recalling firmICU Medical, Inc.951 Calle Amanecer · San Clemente, CA 92673-6212
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/72165-icu-medical-recalls-hemodynamic-monitoring-system-with-pause-mode-thermal.
“ICU Medical recalls Hemodynamic monitoring system with pause mode thermal coil issue.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72165-icu-medical-recalls-hemodynamic-monitoring-system-with-pause-mode-thermal. Based on FDA recall #Z-1775-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1775-2018%22&limit=1).
The FDA announced on Jan. 5, 2018, that ICU Medical, Inc. voluntarily recalled its Hemodynamic monitoring system (HMS) due to a hazard where the catheter thermal coil may continue operating while in pause mode during continuous cardiac output monitoring.
How to tell if you have it
Brand: ICU Medical
Product: Hemodynamic monitoring system (HMS)
Part Number 58401-000 (Patient Interface Module) with UPC 00840619079499
Part Number 58403-000 (User Interface Module) with UPC 00840619079505
The hazard
According to the FDA, 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.
Context
GovInfoNow's records show ICU Medical, Inc. has 60 other recalls on record since June 15, 2017. Other recent recalls of similar products include Gentherm Medical Innercool Coolblue Console Overheating Recall (July 13, 2026), Gentherm Blanketrol III Model 233 Thermal Regulator Overheating Risk (July 13, 2026), and Gentherm Blanketrol II Model : Overheating Risk (July 13, 2026).
How to tell if you have this one
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.
Brand
ICU Medical
Product
Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
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.
Where it went and when
Where it was distributed
Distributed in 6 states.
Listed by the agency
Not listed
FDA distribution: “Distributed to the states of CA, FL, NC, NE, NY, and WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Nebraska, New York, North Carolina, Washington.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1775-2018 (January 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1775-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.