ICU Medical MC100-GRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709037182), received between Jun 25, 2025 and Jun 25, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Flush” (1 report).

52 other recalls cover devices cleared under the same FDA submission (K970855); 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.

• MalfunctionJun 25, 2025Difficult to Flush; No Flow; Difficult to Flush; No Flow

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A MICROCLAVE® CLEAR CONNECTOR W/GREEN RING. THE REPORTER STATED THAT THE DEVICE WILL NOT DRAW OR FLUSH WHEN CONNECTED TO THE VYCON UMBILICAL CATHETER AND BAXTER STOPCOCK DURING USE ON A BABY PATIENT. THE EVENT OCCURRED PRETTY OFTEN NOW AND THEN, MULTIPLE TIMES. THE LINE WAS PLACED IN THE PATIENT, IT WAS UNABLE TO FLUSH AND THE CLINICIAN HAD TO REMOVE THE ADAPTER. THERE WAS DELAY IN THERAPY SINCE THEY HAD TO TRY A FEW BEFORE IT WORKED. HOWEVER, THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327736 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K970855. One submission often covers many models, so check the product and lot details in each record.

• Z-1722-2022 · Aug 1, 2022 · Open, Classified
  MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory for Intravascular Administration S
• Z-0704-2014 · Dec 24, 2013 · Terminated
  28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave T-Connector, Clamp, Rotating Luer, Item # B33071-T, Lot # 2791245. The ICU Needleless Connector is a sin
• Z-0691-2014 · Dec 24, 2013 · Terminated
  7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7099-001 The ICU Needleless Connector is a single use, sterile, non-pyrog
• Z-0659-2014 · Dec 24, 2013 · Terminated
  6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp, Luer Slip, Part No. A1000, Item No. 011-A1002 The ICU Needleless Connector is a single use, sterile, n
• Z-0689-2014 · Dec 24, 2013 · Terminated
  6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7096-001 The ICU Needleless Connector is a single use, sterile, non
• Z-0664-2014 · Dec 24, 2013 · Terminated
  NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular
• Z-0670-2014 · Dec 24, 2013 · Terminated
  78" Ext Set w/Check Valve, CLAVE Clear, Remv 2 Gang 4-Way Stopcocks, NanoClave, NanoClave T-Connector, 4 Clamps, Rotating Luer, 3 Ext, Part No. A1000, Item No. A1026 The ICU Needle
• Z-0665-2014 · Dec 24, 2013 · Terminated
  17 cm (7'') Ext Set w/NanoClave, 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, Part No. A1000, Item No. 011-AC103 The ICU Needleless Connector is a single use, sterile, non-pyrog
• Z-0699-2014 · Dec 24, 2013 · Terminated
  120" 10 Drop Primary Set w/2 BCV-CLAVE, Remv 2 Gang CLAVE Stopcock, Remv CLAVE Stopcock, NanoClave T-Connector, Rotating Luer, 2 Ext, Part No. A1000, Item No. SC125 The ICU Needle
• Z-0685-2014 · Dec 24, 2013 · Terminated
  10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave Clear, Tri- Connector, NanoClave" T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer, Part No. A1000, Item No. K7091-0
• Z-0668-2014 · Dec 24, 2013 · Terminated
  7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE Clear, NanoClave T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1009 The ICU Needleless Connector is a sin
• Z-0674-2014 · Dec 24, 2013 · Terminated
  10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1071 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device
• Z-0667-2014 · Dec 24, 2013 · Terminated
  7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer, Part No. A1000, Item No. A1007 The ICU Needleless Connector is a single use, sterile
• Z-0662-2014 · Dec 24, 2013 · Terminated
  184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave, 2 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCV-Clave, NanoClave TConnector, Rotating Luer, Part No. A1000, Item No. 011-
• Z-0706-2014 · Dec 24, 2013 · Terminated
  6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE Clear, Clamp, NanoClave T-Connector, Rotating Luer, Item # A1003, Lot # 2773812. The ICU Needleless Connector is a single u

…and 37 more.