ICU Medical AC400Recalls & reported problems
Icu Medical, Inc. · 4 Gang 4-Way NanoClave™ Stopcock w/Rotating Luer · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709090347), received between Jun 3, 2025 and May 6, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (2 reports).
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
- Crack2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2026Crack
AN EMAIL WAS RECEIVED REGARDING A 4 GANG 4-WAY NANOCLAVE® STOPCOCK W/ROTATING LUER, ALLEGING 4-GANG STOPCOCKS CRACKED DURING PATIENT USE. THE DEVICE FAILED AT PICU (PEDIATRIC INTENSIVE CARE UNIT) WITH THE REGISTERED NURSE AT THE BEDSIDE. THE DEVICE WAS REPLACED. THERE WAS PATIENT INVOLVEMENT AND NO HARM. THERE WAS MAINTENANCE INTRAVENOUS FLUIDS (MIVF) MIVF RUNNING THROUGH THE 4-GANG AND IT WAS ATTACHED TO A CENTRAL LINE WHICH POSES A RISK FOR INFECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25106848 ↗MalfunctionJun 3, 2025Crack; Crack
IT WAS REPORTED THAT A 4 GANG 4-WAY NANOCLAVE® STOPCOCK WITH ROTATING LUER A REGISTERED NURSE WAS ASSESSING A PATIENT AND NOTICED THE MANIFOLD WAS SPLIT IN HALF. THERE WAS PATIENT INVOLVEMENT, AND NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22135871 ↗
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-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-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-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
- 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
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.
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