ICU Medical AC100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709053151), received between Mar 11, 2026 and Mar 11, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “No Flow” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026No Flow

  MEDWATCH REPORT NUMBER (B)(4) WAS RECEIVED REGARDING A NANOCLAVE STOPCOCK WHERE IT WAS REPORTED THAT THE NEEDLELESS CONNECTOR ON THE 3-WAY STOPCOCK ATTACHED TO THE PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] WAS BROKEN. PATIENT HAS A 2.6 DBL LUMEN PICC. FFP [FRESH FROZEN PLASMA] TRANSFUSION WAS CONNECTED TO THE NEEDLELESS CONNECTOR. SHORTLY INTO THE TRANSFUSION, THE RED LUMEN WAS ALARMING OCCLUDED. TROUBLESHOOTING WITH RNTS FOUND THAT THE NEEDLELESS CONNECTOR WHICH THE FFP WAS CONNECTED TO WAS BROKEN. UNCLEAR WHEN/HOW IT BROKE. FFP TRANSFUSION HAD TO BE PAUSED AND DISCONNECTED TEMPORARILY. STOPCOCK REPLACED WITH RNTS. THE PRODUCT IS CAUSING A PUMP OCCLUSION ALARM, AND FLUIDS WOULD NOT RUN THROUGH THE NEEDLELESS CONNECTOR OF THE STOPCOCK. THIS RESULTS IN A BREAK IN THE LINE TO REPLACE THE PRODUCT. UPON INSPECTING THE STOPCOCK, THE INNER SPONGE OF THE NEEDLELESS CONNECTOR REMAINS DEPRESSED. ADDITIONALLY, RESIDUE WAS NOTED IN THE NEEDLELESS CONNECTOR OF THE STOPCOCK, WHICH MAY HAVE CONTRIBUTED TO THE OCCLUSION ALARM. THE PATIENT INVOLVE IS A 1-MONTH-OLD FEMALE AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570000 ↗

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 · Terminated
  Appx 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-0212-2021 · Jul 6, 2020 · Terminated
  NanoClave 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-0250-2021 · Jul 6, 2020 · Terminated
  Clave 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 · Terminated
  2 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