Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1927-2020·Announced 2020-05-13

ICU Medical Recalls Cogent Hemodynamic Monitoring System Due to Software Defect

ICU Medical is recalling 123 units of the Cogent Hemodynamic Monitoring System because a software issue prevents the system from storing patient IDs and information.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a software defect that prevents data storage. No injuries, illnesses, or deaths are reported in the source text, and the risk is primarily related to data integrity rather than direct physical harm, fitting the criteria for a moderate severity score.

Plain-English summary

ICU Medical, Inc. is recalling 123 units of the Cogent Hemodynamic Monitoring System. The recall involves specific reference numbers (58400-000, 58400-000R, 58403, and 58401) and software versions 1.3.3.42 and prior. The affected devices are distributed nationwide in the United States, including in Arkansas, California, Florida, Illinois, Maryland, North Carolina, Nebraska, New York, Texas, Vermont, Washington, and Wisconsin.

The recall was initiated because the firm identified software issues that lead to patient IDs and patient information not being stored in the system. The Cogent Hemodynamic Monitoring System is intended for the monitoring of continuous cardiac output and calculated hemodynamic parameters for diagnostic and prognostic evaluation by a clinician. The target population includes critical care, trauma, and cardiac surgery patients.

Healthcare facilities and consumers should stop using the affected devices and contact ICU Medical, Inc. for further instructions on the recall.

The recalled product

Product: The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401, GTIN 00840619079499 - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Hemodynamic Monitoring
Hazard: software-defect
data-loss
Affected units: 123

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 (5)

All serial numbers of Cogent HMS
List Number(s): 58400-000
58400-000R
58403-000
58401-000 with Software Versions 1.3.3.42 and prior are impacted.

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Same manufacturer · ICU Medical, Inc.

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