ICU Medical Central Venous Catheters: Guidewire Won't Pass Through Needles
ICU Medical recalls certain central venous catheters due to guidewire not passing through needles, which may affect hemodynamic monitoring. Affected units have specific model and lot numbers.
Lower-risk recall
Inability for the guidewire to pass through the needles included with the catheter kits.
Contact the company
What happened, in plain English
ICU Medical is recalling central venous catheters that have a problem with the guidewire not passing through the needles. This could prevent proper hemodynamic monitoring in medical settings, which is critical for patient care. Read more at govinfonow.com/recall/66178-icu-medical-central-venous-catheters-guidewire-won-t-pass-through.
Source Summary by GovInfoNow · govinfonow.com/recall/66178-icu-medical-central-venous-catheters-guidewire-won-t-pass-through · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2001-2020
Cite this page
“ICU Medical Central Venous Catheters: Guidewire Won't Pass Through Needles.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66178-icu-medical-central-venous-catheters-guidewire-won-t-pass-through. Based on FDA recall #Z-2001-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2001-2020%22&limit=1).
Why it’s dangerous
The catheter's needles may not allow the guidewire to pass through properly. This could lead to incorrect hemodynamic readings, which might affect patient treatment decisions.
Who’s affected
Healthcare professionals using these catheters for hemodynamic monitoring are most at risk. Patients receiving this monitoring may be affected if the catheter is used incorrectly.
How to tell if you have this one
Check for model numbers 41414-23 and lot numbers including 4156000/1 0840619 04647 4, 4174850/1 0840619 04647 4, 4192313/1 0840619 04647 4, or 4330831/1 0840619 04647 4, 4365303/1 0840619 04647 4.
- Brand
ICU Medical- Category
Medical device
All 7 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Consignees including in the states of AL, CA, FL, GA, IL, ME, MI, MN, MS, NC, NH, NM, NY, OH, TX, UT, VA and WA OUS - Canada.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1996-2020 | 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; LOT 4330832 UDI:1 0840619 04197 4 | 20 |
| Z-1997-2020 | 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 # 41401-23.; LOT Number/ UDI-4155346/1 0840619 04409 8, 4174851/1 0840619 04409 8, 4192312/1 0840619 04409 8, 4330851/1 0840619 04409 8, 4351191/1 0840619 04409 8 | 260 units |
| Z-1998-2020 | 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 # 41401-25.; LOT Number/ UDI-4156005/1 0840619 04410 4 | 10 |
| Z-1999-2020 | 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 # 41406-23; LOT Number/ UDI-4155999/1 0840619 04642 9, 4192320/1 0840619 04642 9 | 60 |
| Z-2000-2020 | 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 # 41411-25; LOT Number/ UDI-4192314/1 0840619 04645 0 | 10 |
| Z-2001-2020 | 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; 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 | 235 |
| Z-2002-2020 | 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 # 50456-01; LOT Number/ UDI - 4350491/0 0840619 03011 7 | 15 |
What to do — step by step
Check Product Details
Look for model number 41414-23 and lot numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed in 18 states, and outside the U.S.
FDA distribution: “US Consignees including in the states of AL, CA, FL, GA, IL, ME, MI, MN, MS, NC, NH, NM, NY, OH, TX, UT, VA and WA OUS - Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, California, Florida, Georgia, Illinois, Maine, Michigan, Minnesota, Mississippi, New Hampshire, New Mexico, New York, North Carolina, Ohio, Texas, Utah, Virginia, Washington.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2001-2020 (January 2, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2001-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.