ICU Medical Recalls Hemodynamic Monitoring Systems Due to Pause Mode Defect
ICU Medical is recalling 36 hemodynamic monitoring systems because the catheter thermal coil may continue operating while in Pause mode.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a medical device that may continue to operate (thermal coil) when it should be paused, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling 36 Hemodynamic Monitoring Systems (HMS). The recalled devices consist of a Patient Interface Module (Part Number 58401-000) and a User Interface Module (Part Number 58403-000). These systems are intended for patients in hospitals who require continuous cardiac output monitoring for diagnostic and prognostic evaluation.
The recall was initiated because when continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pause mode, the catheter thermal coil may continue operating while in pause mode. The devices were distributed to the states of California, Florida, North Carolina, Nebraska, New York, and Washington.
Hospitals and healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice. If a device is found, it should be removed from service and returned to ICU Medical, Inc. according to the instructions provided by the manufacturer.
The recalled product
- 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…
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 36
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- (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)
Distribution
Related recalls
Same manufacturer · ICU Medical, Inc.
See all →- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- HighICU Medical Cogent Hemodynamic Monitoring System Recalled for Software Issue
FDA (Devices) · 2021-01-20
- HighICU Medical Cogent Hemodynamic Monitoring System Recalled for Software Issues
FDA (Devices) · 2020-05-06
- ModerateICU Medical Recalls Cogent Hemodynamic Monitoring System Due to Software Defect
FDA (Devices) · 2020-05-13
- ModerateICU Medical Recalls Central Venous Catheters Due to Guidewire Issue
FDA (Devices) · 2020-05-20
- ModerateICU Medical Recalls Central Venous Catheters Due to Guidewire Defect
FDA (Devices) · 2020-05-20
- ModerateICU Medical Recalls Cardiac Catheterization Waste Management Systems
FDA (Devices) · 2012-08-08