Class 2 Device Recall Hemodynamic Monitoring System

• Date Initiated by Firm: January 05, 2018
• Create Date: May 09, 2018
• Recall Status: Terminated on March 18, 2019
• Recall Number: Z-1775-2018
• Recall Event ID: 79814
• 510(K)Number: K152006
• Product Classification: blood pressure cuff - Product Code DXQ
• 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.
• Code Information: 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).
• Recalling Firm/ Manufacturer: ICU Medical, Inc.; 951 Calle Amanecer; San Clemente CA 92673-6212
• For Additional Information Contact: 866-829-9025 Ext. 2
• Manufacturer 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.
• FDA Determined 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 in Commerce: 36 devices
• Distribution: Distributed to the states of CA, FL, NC, NE, NY, and WA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DXQ and Original Applicant = ICU MEDICAL INC.