ICU Medical SC9020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709040373), received between Jul 11, 2023 and Jul 11, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

• MalfunctionJul 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE INCIDENT INVOLVED A MICROCLAVE¿ CONNECTOR. IT WAS REPORTED THAT THE VALVE REMAINED OPEN AFTER THE IV CONTRAST TUBING WAS DISCONNECTED FROM IT. BLOOD RUSHED OUT AS THERE WAS NOTHING TO STOP THE FLOW. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17297954 ↗

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-0671-2014 · Dec 24, 2013 · Terminated
  11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. A1052 The ICU Needleless Connector is a single use, sterile, non-pyr
• 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-0693-2014 · Dec 24, 2013 · Terminated
  10" (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7102-001 The ICU Needleless Connector is a single use,
• Z-0695-2014 · Dec 24, 2013 · Terminated
  11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. K7105-001 The ICU Needleless Connector is a single use, sterile, non
• Z-0705-2014 · Dec 24, 2013 · Terminated
  6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, NanoClave T-Connector, Purple Clamp, Rotating Luer, Item # A1099, Lot # 2791393.
• 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-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-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-0703-2014 · Dec 24, 2013 · Terminated
  5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Rotating Luer, Item # B3304-T, Lot # 2791244. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device int
• Z-0682-2014 · 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. K7088-001 The ICU Needleless Connector is a single use, s
• 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-0684-2014 · Dec 24, 2013 · Terminated
  7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave" T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. K7090-001 The ICU Needleless Connector i
• Z-0669-2014 · Dec 24, 2013 · Terminated
  8" (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1014 The ICU Needleless Con
• 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

…and 37 more.