FDA Medical Device Recalls (openFDA)
ICU Medical, Inc.: 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.
- Recall number
- Z-1775-2018
- Recalling firm
- ICU Medical, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2018-01-05
- Posted
- not on file
- Terminated
- 2019-03-18
- Reason
- 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
- 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 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.
- Quantity
- 36 devices
- Distribution
- Distributed to the states of CA, FL, NC, NE, NY, and WA.
- Lot, serial or model codes
- 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).
- 510(k) numbers
- ["K152006"]
- PMA numbers
- not on file
- Product code
- DXQ
- Firm FEI
- 2025816
- Firm city
- San Clemente
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28