Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2001-2020·Announced 2020-05-20

ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue

ICU Medical is recalling 235 Central Venous Catheters because the included guidewire cannot pass through the needles.

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 source text describes a functional defect (inability to pass guidewire) without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary recalls where harm has not been reported.

Plain-English summary

ICU Medical, Inc. is recalling 235 units of Central Venous Catheters, Model # 41414-23. These devices are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients.

The recall was initiated because the guidewire is unable to pass through the needles included with the catheter kits. This defect prevents the intended use of the device for pressure monitoring.

The affected units were distributed to US consignees in the states of AL, CA, FL, GA, IL, ME, MI, MN, MS, NC, NH, NM, NY, OH, TX, UT, VA, and WA, as well as to consignees in Canada. The specific lot numbers and UDI codes for the recalled units are 4156000/1 0840619 04647 4, 4174850/1 0840619 04647 4, 4192313/1 0840619 04647 4, 4330831/1 0840619 04647 4, and 4365303/1 0840619 04647 4. Healthcare providers should check their inventory for these specific lot numbers and stop using the affected devices.

The recalled product

Product: Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41414-23
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Catheters
Hazard: functional-defect
Affected units: 235

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)

LOT Number/ UDI - 4156000/1 0840619 04647 4
4174850/1 0840619 04647 4
4192313/1 0840619 04647 4
4330831/1 0840619 04647 4
4365303/1 0840619 04647 4

Distribution

Distributed in 19 states:

Part of a larger recall action

This product is one of 7 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · ICU Medical, Inc.

See all →

High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Moderate
ICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
Moderate
ICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23

Same hazard · functional defect