FDA Device recall Z-0859-2021

icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac outpu…

FDA Device
Class II
terminated
Published 2021-01-20

On 2021-01-20 the FDA classified a Class II recall of icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac outpu… by Icu Medical, citing due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0859-2021
Classification	Class II
Status	terminated
Initiated	2020-11-09
Published	2021-01-20
Last updated	2026-09-13 11:56 UTC
Company	Icu Medical
Distribution	US

Product

icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician.

Reason

Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.

Identifiers

code_info	List Number/Item Code: 58400-000 User Interface Module item: 58403-000 Serial Number: TSI701114 TSI701129 TSI7011… List Number/Item Code: 58400-000 User Interface Module item: 58403-000 Serial Number: TSI701114 TSI701129 TSI701136 TSI701180 TSI701179 TSH901670 TSH200797 TSH901640 TSH900431 TSI701174 TSH200801 TSH200767 TSI701173 TSI802195 TSH101376 TSH200764 TSH901982 TSH901985 TSH901602 THS901630 TSH901576 TSH901639 TSH901622 TSH901641 TSH901620 TSH901604 TSH901988 TSH901595 TSH901597 TSH901588 TSI701113 TSI701112 TSI701110 TSI701115 TSI701105 TSH900444 TSH900449 TSH901612 TSH901610 TSI701177 TSI701178 TSI701125 TSI701127 TSI701184 TSI701185 TSI701186 TSI701169 TSI701128 TSFA01684 TSFA01695 TSH101367 TSH901666 TSI701119 TSI701120 TSH901642 TSH901674 TSH901662 TSH901626 TSH901644 TSH901627 TSH901572 TSFA01683 TSH101379 TSH901643 TSH200798 TSH900438 TSH900411 TSH901594 TSH901991 TSH200832 TSH901648 TSH101337 TSH200780 TSH200763 TSH900406 TSH900409 TSH200802 TSH900434 TSH901581 TSH901636 TSH901632 TSH901619 TSH90164

code_info

List Number/Item Code: 58400-000 User Interface Module item: 58403-000 Serial Number: TSI701114 TSI701129 TSI7011…

List Number/Item Code: 58400-000 User Interface Module item: 58403-000 Serial Number: TSI701114 TSI701129 TSI701136 TSI701180 TSI701179 TSH901670 TSH200797 TSH901640 TSH900431 TSI701174 TSH200801 TSH200767 TSI701173 TSI802195 TSH101376 TSH200764 TSH901982 TSH901985 TSH901602 THS901630 TSH901576 TSH901639 TSH901622 TSH901641 TSH901620 TSH901604 TSH901988 TSH901595 TSH901597 TSH901588 TSI701113 TSI701112 TSI701110 TSI701115 TSI701105 TSH900444 TSH900449 TSH901612 TSH901610 TSI701177 TSI701178 TSI701125 TSI701127 TSI701184 TSI701185 TSI701186 TSI701169 TSI701128 TSFA01684 TSFA01695 TSH101367 TSH901666 TSI701119 TSI701120 TSH901642 TSH901674 TSH901662 TSH901626 TSH901644 TSH901627 TSH901572 TSFA01683 TSH101379 TSH901643 TSH200798 TSH900438 TSH900411 TSH901594 TSH901991 TSH200832 TSH901648 TSH101337 TSH200780 TSH200763 TSH900406 TSH900409 TSH200802 TSH900434 TSH901581 TSH901636 TSH901632 TSH901619 TSH90164

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0859-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.