Recall of Device Recall Hemodynamic Monitoring System

Recall

79814

Class 2

Z-1775-2018

2018-01-05

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163535

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.

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 recall@icumed.com. 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.