ICU Medical AC401Recalls & reported problems
Icu Medical, Inc. · Appx 1.1 ml, 4 Gang 4-Way NanoClave™ Stopcock w/Baseplate, Rotating Luer · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709090354), received between Aug 26, 2024 and Aug 26, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K080077); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2024Material Separation; Material Separation
THE EVENT INVOLVED A APPX 1.1 ML, 4 GANG 4-WAY NANOCLAVE® STOPCOCK W/BASEPLATE, ROTATING LUER. THE REPORT STATED THAT THE REGISTERED NURSE USED HEMOSTATS ON THE MANIFOLD AND A NANOCLAVE PORT BROKE OFF. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO HARM/ADVERSE EVENT REPORTED. THE PRODUCT FAULT OCCURS WHILE IN USE WITH A PATIENT- AFTER INFUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20072772 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K080077. One submission often covers many models, so check the product and lot details in each record.
- Z-0250-2021 · Jul 6, 2020 · TerminatedClave Stopcock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709039916(17)250201(30)50(10)4727496. The ICU Medical Clave Stopcock is a device used to administer o
- Z-0212-2021 · Jul 6, 2020 · TerminatedNanoClave Stopcock w/NanoClave; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062112(17)250101(30)50(10)4572842. The ICU Medical Clave Stopcock is a device used
- Z-0220-2021 · Jul 6, 2020 · TerminatedAppx 0.82 ml, 3 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053189(17)241201(30)50(10)4537253;(01)108877
- Z-0213-2021 · Jul 6, 2020 · Terminated2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053172(17)241201(30)50(10)4493459;(01)10887709053172(17)24
Other Stopcock, i.V. Set devices
- Connecta, Luer-Lok 394910BD Switzerland Sàrl · Stopcock, i.V. Set3 recalls8 reports
- Outlook® 490361B. Braun Medical Inc. · Stopcock, i.V. Set3 recalls0 reports
- Blood Administration Set 490530B. Braun Medical Inc. · Stopcock, i.V. Set2 recalls11 reports
- Medex MX9341LIcu Medical, Inc. · Stopcock, i.V. Set63 reports
- ICU Medical AC135Icu Medical, Inc. · Stopcock, i.V. Set1 recall10 reports
- IV Administration Set 490067B. Braun Medical Inc. · Stopcock, i.V. Set1 recall9 reports
- ICU Medical MC330174Icu Medical, Inc. · Stopcock, i.V. Set1 recall4 reports
- ICU Medical Z2587Icu Medical, Inc. · Stopcock, i.V. Set1 recall3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page