ICU Medical 011-C1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840619000011), received between Oct 19, 2018 and Sep 17, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Fluid/Blood Leak

  The event involved Clave Connector. It was reported Patient's mom advised once they had connected the bionector was leaking so they had to change it and use another bag. The status of the product at the time of the event when it was Connected to the patient. Unknown, leak observed after patient connected. The event occurred on (b)(6) 2026. The product in clinical use at the time of event. There was patient involvement. No patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50807925 ↗
• MalfunctionNov 29, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A CLAVE® CONNECTOR. THE HEAD OF ONCOLOGY AT THE HOSPITAL REPORTED THAT THE SET DISASSEMBLED DURING TREATMENT (AFTER APPROXIMATELY ONE HOUR). MICRODROPLETS IN PINK COLOR (DOXORUBICIN) WAS OBSERVED ON THE MEMBRANE SIDE. THE PROBLEM WAS NOTICED DURING HANDLING AT THE MOMENT OF DISCONNECTION AFTER TREATMENT. ALTHOUGH THERE WAS A PATIENT INVOLVED, THERE WAS NO DELAY IN THERAPY, NO ADVERSE EVENT AND NO ONE HARMED AS A RESULT OF THIS EVENT. NEITHER THE PATIENT NOR THE CLINICAL PROFESSIONAL WERE IN CONTACT WITH THE FLUID, BECAUSE THE INCIDENT WAS DETECTED AND THE DEVICE WAS DISPOSED OF USING PROTECTIVE MEASURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18235043 ↗
• MalfunctionNov 17, 2023Break; Break

  THE EVENT INVOLVED A CLAVE¿ CONNECTOR IN WHICH THE CUSTOMER REPORTED THAT THERE APPEARS TO BE A PIECE OF PLASTIC THAT HAS BROKEN OFF THE CLAVE CONNECTOR WHEN BEING CONNECTED TO THE SYRINGE, AND GOT CAUGHT AT THE END OF THE SYRINGE WHICH WAS STOPPING THE LIQUID FROM BEING DISPENSED. THE SYRINGE WAS DISPOSED OF. THE CLAVE CONNECTOR IS STORED ON THE CUSTOMER TROLLEYS IN THE CHEMOTHERAPY DEPARTMENT LIKE THEIR OTHER CONSUMABLES. NO DEFECTS WERE NOTED BEFORE THE PRODUCT WAS OPENED. THERE WAS UNKNOWN PATIENT INVOLVEMENT, HOWEVER, HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18166135 ↗
• MalfunctionSep 15, 2023Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  THE REPORTED COMPLAINT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CLAVE® CONNECTOR. IT WAS REPORTED THAT THE PATIENT'S MOTHER FOUND HER GIRL COVERED IN BLOOD DUE TO LEAKAGE FROM THE CONNECTION BETWEEN THE CLAVE CONNECTOR AND THE ADMINISTRATION SET. SHE IDENTIFIED THAT THE CLAVE CONNECTOR WAS BLOCKED AT THE SMALL VALVE ON THE TIP AND THE VALVE DID NOT LIFT AFTER USE; IT REMAINED OPEN AND DID NOT CLOSE. THE DEVICE WAS IMMEDIATELY REPLACED. THE COMPLAINANT FURTHER STATED THAT THE PATIENT LOST A LOT OF BLOOD WHICH DIRTIED HER UNDERSHIRT, PAJAMAS, AND SHEET. ALTHOUGH THE PATIENT WAS IMPACTED, THERE WERE NO CONSEQUENCES OR HARM AS A RESULT OF THE COMPLAINT/ISSUE/EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17755756 ↗
• MalfunctionOct 19, 2018Backflow; Defective Device; Backflow; Defective Device

  THE EVENT INVOLVED A CUSTOMER ALLEGATION STATING THAT DURING CONNECTION TO ARTERIAL ACCESS PROCEDURE, THE MICROCLAVE VALVES DID NOT CLOSE AFTER ASPIRATION, NOTING BLOOD LEAKAGE. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT, NO MEDICAL OR SURGICAL INTERVENTION PROVIDED, NO CLINICALLY SIGNIFICANT BLOOD LOSS AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7987236 ↗

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-0687-2014 · Dec 24, 2013 · Terminated
  78" Ext Set w/2 BCV-Clave, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connector, 4 Clamps, Rotating Luer, 3 Exts, Part No. A1000, Item No. K7094-001 The ICU Needleless Connector is
• Z-0707-2014 · Dec 24, 2013 · Terminated
  17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave ( Light Blue, Lavender Rings), 3 Anti-Syphon Valves, Rotating Luer, Item #011-A1096, Lot # 2796668. The ICU Needleless Connector
• 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-0683-2014 · Dec 24, 2013 · Terminated
  7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave Clear, NThe ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intr
• 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-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-0675-2014 · Dec 24, 2013 · Terminated
  87" (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave, 0.2 Micron Filter, 4 Clamps, Rotating Luer, 2 Exts, Drop-In NanoClave, Part No. A1000, Item No. A1078 The ICU Needl
• Z-0676-2014 · Dec 24, 2013 · Terminated
  13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave, Rotating Luer, Part No. A1000, Item No. A1080 The ICU Needleless Connector is a single use, sterile, non-py
• Z-0678-2014 · Dec 24, 2013 · Terminated
  103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Siphon Valve, Check Valve, 2 Clamps, Luer Lock, Part No. A1000, Item No. A1093 The ICU Needleless Connector
• 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-0697-2014 · Dec 24, 2013 · Terminated
  8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7107-001 The ICU Needleless Connector is a single use, sterile, no
• Z-0696-2014 · Dec 24, 2013 · Terminated
  13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClave Clear (Yellow, Red, Green Rings), 6 Clamps, Rotating Luer, Part No. A1000, Item No. K7106-001 The ICU
• Z-0701-2014 · Dec 24, 2013 · Terminated
  5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot # 2791358. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device in
• Z-0694-2014 · Dec 24, 2013 · Terminated
  7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7103-001 The ICU Needleless Connector is a single use, sterile, non-pyroge

…and 37 more.