Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.
FDA Recall Z-1775-2018 · Posted None
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Recalling FirmICU Medical, Inc.
Recall StatusTerminated
Product CodeDXQ
Date Initiated2018-01-05
Date Terminated2019-03-18
Product Quantity36 devices
Reason for Recall
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.
Firm Action
On about 01/05/2018 customers were notified via an Urgent: Medical Device Correction letter of the recall. The letter identified the affected device and the reason for the correction. Instructions included to inspect current inventory for affected devices and complete and return the Urgent: Medical device Correction Response Form to [email protected]. Customers were notified that they did not need to discontinue using the Cogent Hemodynamic Monitoring System (HMS), but were instructed to disconnect the thermal coil cable from the monitor to discontinue continuous cardiac output (CCO) instead of using the 'Pause' button. Instructions on how to disconnect and reconnect the thermal coil cable from the monitor were provided. Customers may contact ICU Customer Service at 1-866-829-9025, if there are additional questions.
Root Cause
Software design
Distribution Pattern
Distributed to the states of CA, FL, NC, NE, NY, and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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