Z-1775-2018Class II

Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a...

Name: Z-1775-2018 Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a...
Creator: ICU Medical, Inc.
Published: 2018-01-05
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-01-05 / Terminated / root cause: software

FDA source

ICU Medical, Inc. began a recall of Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000)... on 2018-01-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1775-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-05
Posted: 2018-05-09
Terminated: 2019-03-18
Recalling firm: Abbott Medical
Product: 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.
Product code: DXQ Blood Pressure Cuff
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 36 devices
Distribution: Distributed to the states of CA, FL, NC, NE, NY, and WA.
Product codes and lots: a. Part Number 58401-000 - UDI (Serial No.): (01)00840619079499(11)170615(21)1647100134 (1647100134), (01)00840619079499(11)170912(21)1647100137 (1647100137), (01)00840619079499(11)170912(21)1731100224 (1731100224), (01)00840619079499(11)170914(21)17311002301 (731100230), (01)00840619079499(11)170914(21)1731100228 (1731100228), (01)00840619079499(11)170605(21)1647100140 (1647100140), (01)00840619079499(11)170822(21)1647100135 (1647100135), (01)00840619079499(11)170825(21)1726100215 (1726100215), (01)00840619079499(11)170721(21)1726100214 (1726100214), (01)00840619079499(11)170801(21)1718100164 (1718100164), (01)00840619079499(11)170615(21)1647100139 (1647100139), (01)00840619079499(11)170822(21)1647100146 (1647100146), (01)00840619079499(11)170822(21)1647100136 (1647100136), (01)00840619079499(11)170716(21)1711100147 (1711100147), (01)00840619079499(11)170615(21)1647100143 (1647100143), (01)00840619079499(11)170824(21)1726100204 (1726100204), (01)00840619079499(11)170712(21)1718100166 (1718100166), (01)00840619079499(11)170824(21)1726100205 (1726100205), (01)00840619079499(11)170922(21)1731100241 (1731100241), (01)00840619079499(11)170915(21)1731100231 (1731100231), (01)00840619079499(11)170925(21)1731100243 (1731100243), (01)00840619079499(11)170615(21)1647100144 (1647100144), (01)00840619079499(11)170831(21)1726100209 (1726100209), (01)00840619079499(11)170830(21)1726100218 (1726100218), (01)00840619079499(11)170809(21)1726100216 (1726100216), (01)00840619079499(11)170906(21)1726100210 (1726100210), (01)00840619079499(11)170911(21)1731100220 (1731100220), (01)00840619079499(11)170913(21)1731100226 (1731100226), (01)00840619079499(11)170716(21)1711100154 (1711100154), (01)00840619079499(11)170716(21)1711100155 (1711100155), (01)00840619079499(11)170715(21)1711100151 (1711100151), (01)00840619079499(11)170715(21)1711100150 (1711100150), (01)00840619079499(11)170727(21)1718100171 (1718100171), (01)00840619079499(11)170801(21)1718100173 (1718100173), (01)00840619079499(11)170731(21)1718100159 (1718100159), (01)00840619079499(11)170801(21)1726100213 (1726100213), (01)00840619079499(11)170720(21)1711100157 (1711100157), (01)00840619079499(11)160512(21)1629100112 (1629100112), (01)00840619079499(11)170912(21)1731100222 (1731100222), (01)00840619079499(11)160523(21)1629100120 (1629100120), (01)00840619079499(11)170728(21)1718100162 (1718100162), (01)00840619079499(11)170911(21)1731100221 (1731100221), (01)00840619079499(11)170913(21)1731100227 (1731100227), (01)00840619079499(11)170914(21)1731100229 (1731100229), (01)00840619079499(11)170911(21)1731100219 (1731100219), (01)00840619079499(11)170919(21)1731100239 (1731100239), (01)00840619079499(11)170918(21)1731100238 (1731100238), (01)00840619079499(11)170920(21)1731100237 (1731100237), (01)00840619079499(11)170807(21)1647100141 (1647100141), (01)00840619079499(11)160512(21)1629100118 (1629100118), (01)00840619079499(11)160512(21)1629100116 (1629100116), (01)00840619079499(11)170717(21)1711100148 (1711100148), (01)00840619079499(11)170720(21)1711100152 (1711100152), (01)00840619079499(11)170720(21)1711100149 (1711100149), (01)00840619079499(11)170726(21)1718100160 (1718100160), (01)00840619079499(11)170728(21)1718100161 (1718100161), (01)00840619079499(11)170925(21)1731100244 (1731100244), (01)00840619079499(11)170615(21)1647100138 (1647100138), (01)00840619079499(11)170911(21)1718100172 (1718100172), (01)00840619079499(11)170716(21)1718100169 (1718100169), (01)00840619079499(11)160908(21)1629100103 (1629100103), (01)00840619079499(11)160908(21)1629100105 (1629100105), (01)00840619079499(11)160505(21)1629100111 (1629100111), (01)00840619079499(11)160520(21)1629100113 (1629100113), (01)00840619079499(11)160523(21)1629100117 (1629100117), (01)00840619079499(11)160523(21)1629100123 (1629100123), (01)00840619079499(11)160523(21)1629100124 (1629100124), (01)00840619079499(11)170922(21)1731100240 (1731100240), (01)00840619079499(11)160526(21)1629100122 (1629100122), (01)00840619079499(11)160525(21)1629100119 (1629100119); b. Part Number 58403-000 - UDI (Serial No.): (01)00840619079505(11)151126(21)140165 (140165), (01)00840619079505(11)151126(21)140153 (140153), (01)00840619079505(11)170207(21)TSH101367 (TSH101367), (01)00840619079505(11)170308(21)TSH200754 (TSH200754), (01)00840619079505(11)170308(21)TSH200753 (TSH200753), (01)00840619079505(11)151126(21)140146 (140146), (01)00840619079505(11)151126(21)140131 (140131), (01)00840619079505(11)170308(21)140260 (140260), (01)00840619079505(11)170308(21)140228 (140228), (01)00840619079505(11)170207(21)140186 (140186), (01)00840619079505(11)151126(21)140151 (140151), (01)00840619079505(11)151126(21)140133 (140133), (01)00840619079505(11)151126(21)140166 (140166), (01)00840619079505(11)170207(21)140227 (140227), (01)00840619079505(11)151126(21)140126 (140126), (01)00840619079505(11)170308(21)140259 (140259), (01)00840619079505(11)170207(21)140210 (140210), (01)00840619079505(11)170207(21)140191 (140191), (01)00840619079505(11)170308(21)TSH200773 (TSH200773), (01)00840619079505(11)170308(21)TSH200822 (TSH200822), (01)00840619079505(11)170308(21)TSH200748 (TSH200748), (01)00840619079505(11)151126(21)140130140130 (01)00840619079505(11)170207(21)140198 (140198), (01)00840619079505(11)170207(21)TSH101372 (TSH101372), (01)00840619079505(11)170207(21)140207 (140207), (01)00840619079505(11)170207(21)140220 (140220), (01)00840619079505(11)170207(21)TSH101379 (TSH101379), (01)00840619079505(11)170308(21)TSH200814 (TSH200814), (01)00840619079505(11)170207(21)140173 (140173), (01)00840619079505(11)170207(21)140176 (140176), (01)00840619079505(11)170207(21)140178 (140178), (01)00840619079505(11)170207(21)140188 (140188), (01)00840619079505(11)170207(21)140221 (140221), (01)00840619079505(11)170207(21)140223 (140223), (01)00840619079505(11)170308(21)140276 (140276), (01)00840619079505(11)170308(21)140233 (140233), (01)00840619079505(11)170308(21)140277 (140277), (01)00840619079505(11)151126(21)140144 (140144), (01)00840619079505(11)170207(21)TSH101369 (TSH101369), (01)00840619079505(11)151126(21)TSFA01666TSFA01666 (01)00840619079505(11)170207(21)TSH101375 (TSH101375), (01)00840619079505(11)170207(21)TSH101381 (TSH101381), (01)00840619079505(11)170308(21)TSH200815 (TSH200815), (01)00840619079505(11)170308(21)TSH200755 (TSH200755), (01)00840619079505(11)170207(21)TSH101380 (TSH101380), (01)00840619079505(11)170308(21)TSH200818 (TSH200818), (01)00840619079505(11)170308(21)TSH200821 (TSH200821), (01)00840619079505(11)170308(21)TSH200811 (TSH200811), (01)00840619079505(11)151126(21)TSFA01663 (TSFA01663), (01)00840619079505(11)151126(21)TSFA01667 (TSFA01667), (01)00840619079505(11)151126(21)TSFA01658 (TSFA01658), (01)00840619079505(11)170207(21)TSH101354 (TSH101354), (01)00840619079505(11)170207(21)TSH101353 (TSH101353), (01)00840619079505(11)170308(21)TSH200739 (TSH200739), (01)00840619079505(11)170207(21)TSH101386 (TSH101386), (01)00840619079505(11)170207(21)TSH101349 (TSH101349), (01)00840619079505(11)170308(21)TSH200752 (TSH200752), (01)00840619079505(11)151126(21)TSFA01695 (TSFA01695), (01)00840619079505(11)170207(21)TSH101351 (TSH101351), (01)00840619079505(11)170308(21)TSH200742 (TSH200742), (01)00840619079505(11)151126(21)140129 (140129), (01)00840619079505(11)151126(21)140137 (140137), (01)00840619079505(11)151126(21)140155 (140155), (01)00840619079505(11)151126(21)140171 (140171), (01)00840619079505(11)151126(21)140159 (140159), (01)00840619079505(11)151126(21)140147 (140147), (01)00840619079505(11)151126(21)140138 (140138), (01)00840619079505(11)170308(21)TSH200771 (TSH200771), (01)00840619079505(11)151126(21)140172 (140172), (01)00840619079505(11)151126(21)140123 (140123).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1775-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1775-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-09

Product code DXQ

K152006Class IICogent Hemodynamic Monitoring SystemIcu Medical, Inc. / cleared 2016-05-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)