ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue
ICU Medical is recalling 20 Central Venous Catheters because the included guidewire cannot pass through the needles. The product was distributed to US consignees and Canada.
What this means for you
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 does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving a functional defect without reported harm.
Plain-English summary
ICU Medical, Inc. is recalling 20 units of Central Venous Catheters, identified by Lot Number 4330832 and UDI 1 0840619 04197 4. These devices are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring.
The recall was initiated because the guidewire included with the catheter kits is unable to pass through the needles. 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.
Healthcare providers and consumers who have these specific units should stop using them and contact ICU Medical, Inc. for further instructions.
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. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 20
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 (1)
- LOT 4330832 UDI:1 0840619 04197 4
Distribution
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 →Related recalls
Same manufacturer · ICU Medical, Inc.
See all →- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
- SevereICU Medical Plum Duo Infusion Pump Software Defect Affecting Drug Delivery
FDA (Devices) · 2026-07-22
- SevereICU Medical Plum Solo Precision IV Pump May Deliver Excess Medication
FDA (Devices) · 2026-07-22
- HighPlum Duo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- HighPlum Solo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
Same hazard · functional defect
See all →- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighAngiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk
FDA (Devices) · 2026-04-29
- SevereGE Healthcare CARESTATION anesthesia systems ventilation malfunction recall
FDA (Devices) · 2025-05-07