ICU Medical 12568Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00887709042377), received between May 24, 2019 and Dec 19, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Contamination; Contamination

  IT WAS REPORTED THAT A CLAVE¿ NEUTRAL CONNECTOR WAS FOUND TO HAVE PARTICULATE MATTER IN THE FLUID PATH. THE REPORT STATED THAT THERE HAVE BEEN LITTLE BLACK FLAKES INSIDE THE CLAVES. THEY NOTICED IT BEFORE CHANGING THE CLAVE. A SAMPLE PHOTO WAS ALSO PROVIDED SHOWING SEALED PRODUCT PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23856150 ↗
• MalfunctionAug 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  TWO PARTS OF A CLAVE¿ NEUTRAL CONNECTOR REPORTEDLY SNAPPED AND STARTED LEAKING THE PATIENT'S UNSPECIFIED DRUG DURING AN INFUSION. THERE WAS NO ADVERSE EVENT AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22729483 ↗
• MalfunctionSep 18, 2024Material Separation; Material Separation

  A COMPLAINT REGARDING A MICROCLAVE® NEUTRAL CONNECTOR EXPERIENCED DISCONNECTION. THE REPORT STATED THAT THE CLAVES BECOMES DETACHED FROM EXTENSION SET. NURSING NOTICED THAT THE THREADS IN THE CLAVE ARE NOT MATCHING/GRIPPING TO THE EXTENSION SET. IT WAS NOT DETECTED PRIOR TO DIRECT PATIENT USE. INVOLVED MATING DEVICE IS MEDLINE EXTENSION TUBING. THERE WAS NO BLOOD LOSS AND UNPROTECTED CHEMO EXPOSURE. THERE WAS NO ADVERSE OPERATOR CONSEQUENCES. THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED AND THE INVOLVED DEVICE AVAILABLE TO BE TESTED. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT OR PATIENT HARM AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251394 ↗
• MalfunctionMar 8, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT INVOLVED A CLAVE¿ NEUTRAL CONNECTOR WHERE IT WAS REPORTED DURING PATIENT INFUSION OF TOTAL PARENTERAL NUTRITION (TPN), THE MICROCLAVE SPUN OR POPPED OFF THE MALE LUER AT THE DISTAL END OF THE BD PRIMARY TUBING SET. THE MICROCLAVE WAS CONNECTED TO THE END OF THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WHERE THEY WOULD NORMALLY HAVE IT. THIS CAUSED A LEAKING ISSUE AND CONCERN FOR THE VASCULAR TEAM. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT AND NO ONE WAS HARMED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18864245 ↗
• MalfunctionMar 4, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A MICROCLAVE® NEUTRAL CONNECTOR THAT REPORTEDLY SPUN/POPPED OFF OF THE MALE LUER AT THE DISTAL END OF A BD PRIMARY TUBING SET DURING A TPN (TOTAL PARENTAL NUTRITION) INFUSION AT APPROXIMATELY 2:00 PM. THE MICROCLAVE WAS CONNECTED TO THE END OF THE PICC LINE WHERE THEY WOULD NORMALLY HAVE IT. THIS CAUSED A LEAKING ISSUE AND CONCERN FOR THE VASCULAR TEAM AT THE FACILITY. THERE WAS NO ADVERSE EVENT AND NO ONE WAS HARMED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825739 ↗
• MalfunctionJan 9, 2024Infusion or Flow Problem; Infusion or Flow Problem

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A MICROCLAVE® NEUTRAL CONNECTOR WHERE THE CUSTOMER REPORTED INCONSISTENT FLOW WHEN USING THE MICROCLAVE CONNECTOR DURING PATIENT USE. THERE WERE NO OBVIOUS DEFECTS ON THE DEVICE UPON REMOVAL FROM THE PACKAGE. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO PATIENT HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18477499 ↗
• MalfunctionJun 3, 2022Air/Gas in Device; Air/Gas in Device

  THE EVENT OCCURRED ON UNSPECIFIED DATE IN APRIL OF 2022 INVOLVING A MICROCLAVE® NEUTRAL CONNECTOR WHERE IT WAS REPORTED THAT THE HUB OF THE IV IS FALLING OFF/APART, AND AN AIR EMBOLISM WAS IDENTIFIED ON COMPUTED TOMOGRAPHY (CT) ON THE PERIPHERAL SITE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS THE FOURTH OF EIGHT EVENTS.

  Patient problems: Air Embolism

  MAUDE report 14597026 ↗
• MalfunctionJun 3, 2022Air/Gas in Device; Air/Gas in Device

  THE EVENT OCCURRED ON UNSPECIFIED DATE IN APRIL OF 2022 INVOLVING A MICROCLAVE® NEUTRAL CONNECTOR WHERE IT WAS REPORTED THAT THE HUB OF THE IV IS FALLING OFF/APART, AND AN AIR EMBOLISM WAS IDENTIFIED ON COMPUTED TOMOGRAPHY (CT) ON THE PERIPHERAL SITE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS THE EIGHT OF EIGHT EVENTS.

  Patient problems: Air Embolism

  MAUDE report 14597023 ↗
• MalfunctionJun 3, 2022Air/Gas in Device; Air/Gas in Device

  THE EVENT OCCURRED ON UNSPECIFIED DATE ON (B)(6) 2022 INVOLVING A MICROCLAVE® NEUTRAL CONNECTOR WHERE IT WAS REPORTED THAT THE HUB OF THE IV IS FALLING OFF/APART, AND AN AIR EMBOLISM WAS IDENTIFIED ON COMPUTED TOMOGRAPHY (CT) ON THE PERIPHERAL SITE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS THE SIXTH OF EIGHT EVENTS.

  Patient problems: Air Embolism

  MAUDE report 14597018 ↗
• MalfunctionJun 3, 2022Air/Gas in Device; Air/Gas in Device

  THE EVENT OCCURRED ON UNSPECIFIED DATE IN APRIL OF 2022 INVOLVING A MICROCLAVE® NEUTRAL CONNECTOR WHERE IT WAS REPORTED THAT THE HUB OF THE IV IS FALLING OFF/APART, AND AN AIR EMBOLISM WAS IDENTIFIED ON COMPUTED TOMOGRAPHY (CT) ON THE PERIPHERAL SITE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS THE FIFTH OF EIGHT EVENTS.

  Patient problems: Air Embolism

  MAUDE report 14596996 ↗
• MalfunctionJun 3, 2022Air/Gas in Device; Air/Gas in Device

  THE EVENT OCCURRED ON UNSPECIFIED DATE IN (B)(6) 2022 INVOLVING A MICROCLAVE® NEUTRAL CONNECTOR WHERE IT WAS REPORTED THAT THE HUB OF THE IV IS FALLING OFF/APART, AND AN AIR EMBOLISM WAS IDENTIFIED ON COMPUTED TOMOGRAPHY (CT) ON THE PERIPHERAL SITE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS THE SEVENTH OF EIGHT EVENTS.

  Patient problems: Air Embolism

  MAUDE report 14596992 ↗
• MalfunctionJun 3, 2022Air/Gas in Device; Air/Gas in Device

  THE EVENT OCCURRED ON UNSPECIFIED DATE IN (B)(6) 2022 INVOLVING A MICROCLAVE® NEUTRAL CONNECTOR WHERE IT WAS REPORTED THAT THE HUB OF THE IV IS FALLING OFF/APART, AND AN AIR EMBOLISM WAS IDENTIFIED ON COMPUTED TOMOGRAPHY (CT) ON THE PERIPHERAL SITE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS THE THIRD OF EIGHT EVENTS.

  Patient problems: Air Embolism

  MAUDE report 14596981 ↗
• MalfunctionJun 3, 2022Air/Gas in Device; Air/Gas in Device

  THE EVENT OCCURRED ON UNSPECIFIED DATE IN APRIL OF 2022 INVOLVING A MICROCLAVE® NEUTRAL CONNECTOR WHERE IT WAS REPORTED THAT THE HUB OF THE IV IS FALLING OFF/APART, AND AN AIR EMBOLISM WAS IDENTIFIED ON COMPUTED TOMOGRAPHY (CT) ON THE PERIPHERAL SITE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS THE FIRST OF EIGHT EVENTS.

  Patient problems: Air Embolism

  MAUDE report 14596975 ↗
• MalfunctionJun 3, 2022Air/Gas in Device; Air/Gas in Device

  THE EVENT OCCURRED ON UNSPECIFIED DATE IN APRIL OF 2022 INVOLVING A MICROCLAVE® NEUTRAL CONNECTOR WHERE IT WAS REPORTED THAT THE HUB OF THE IV IS FALLING OFF/APART, AND AN AIR EMBOLISM WAS IDENTIFIED ON COMPUTED TOMOGRAPHY (CT) ON THE PERIPHERAL SITE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS THE SECOND OF EIGHT EVENTS.

  Patient problems: Air Embolism

  MAUDE report 14596970 ↗
• MalfunctionApr 26, 2022Crack; Air/Gas in Device; Crack; Air/Gas in Device

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A MICROCLAVE® NEUTRAL CONNECTOR. IT WAS REPORTED THAT THE PUMP ALARMED OCCLUSION DURING AN INFUSION WITH AN UMBILICAL VENOUS CATHETER (UVC) INFUSING TOTAL PARENTERAL NUTRITION (TPN) AND INTRALIPID (IL). THE NURSE VISUALLY ASSESSED THE LINE TO THE BABY AND NOTICED AN UNSPECIFIED AMOUNT OF AIR IN THE LINE. IT WAS STATED THAT THE CLAVE NEUTRAL CONNECTOR WAS CRACKED IN THE BLUE CLAVE. THE AIR BUBBLE DID NOT REACH THE PATIENT AND THE CLAVE WAS CHANGED OUT. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14211741 ↗
• MalfunctionMay 24, 2019Crack; Leak/Splash

  THE MED TUBING HAD A SMALL CRACK AND WAS LEAKING AT THE CLAVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8639940 ↗

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-0681-2014 · Dec 24, 2013 · Terminated
  6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/Luer Slip, Part No. A1000, Item No. K7085-001 The ICU Needleless Connector is a single use, sterile, no
• Z-0666-2014 · Dec 24, 2013 · Terminated
  6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave TConnector, Rotating Luer, Part No. A1000, Item No. A1001 The ICU Needleless Connector is a single use, sterile, non-p
• 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-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-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-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-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-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-0658-2014 · Dec 24, 2013 · Terminated
  NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z3769 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended fo
• 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-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-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-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-0677-2014 · Dec 24, 2013 · Terminated
  14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, 2 Clamps, Rotating Luer, Part No. A1000, Item No. A1081 The ICU Needleless Connector is a single use, s

…and 37 more.