ICU Medical 11956Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00887709042193), received between Jan 21, 2020 and Dec 8, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Particulates; Particulates

  ON AN UNSPECIFIED DATE, A CLAVE¿ CONNECTOR REPORTEDLY WAS ASSOCIATED WITH PARTICULATE MATTER IN FINAL DRUG PRODUCT ACROSS MULTIPLE LOTS. THE FINAL DRUG PRODUCT CONTAINED PARTICULATES SUCH AS CELLULOSE/LIGNIN, CELLULOSE FIBER, POLYPROPYLENE, POLYETHYLENE, PVDF-HFP, TEXTILE COTTON FIBER, TEXTILE POLYESTER FIBER, EVA, INDIGO CELLULOSE OR COTTON FIBER AND FLUOROCARBON-BASED MATERIAL. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23752356 ↗
• MalfunctionDec 8, 2025Fluid/Blood Leak; Mechanical Jam; Fluid/Blood Leak; Mechanical Jam

  AN EVENT INVOLVED A CLAVE CONNECTOR WHERE THE CUSTOMER REPORTED THAT THE CLAVE MALFUNCTIONED; THE RUBBER STOPPER WAS STUCK IN THE CLAVE AND IT LEAKED MEDICATION, CAUSING THE PATIENT HAVING TO BE RESCHEDULED. THERE WAS PATIENT INVOLVEMENT BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23739634 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CLAVE¿ CONNECTOR WHERE IT WAS REPORTED THAT THE 5-FU (5-FLUOROURACIL) MEDICATION WAS LEAKING FROM IV LINE SYSTEM. ADDITIONALLY, IT WAS NOTED THAT THE INNER DIAPHRAGM WAS RETRACTED AND TWISTED. SOME OF THE PRODUCT END UP ON THE SKIN AT RIGHT TORSO. THE PATIENT STOPPED CADD (COMPUTERIZED AMBULATORY DRUG DELIVERY) PUMP AS PREVIOUSLY INSTRUCTED AND CLEANED THE SKIN AREA WITH SOAP AND WATER. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302383 ↗
• MalfunctionAug 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLAVE¿ CONNECTOR GENERATED A LEAK DURING PATIENT USE. THE REPORTER STATED THAT THEY NOTICED INCIDENTS OF FAULTY BLUE CHEMOLOCK CAPS, WHICH HAVE CAUSED A CHEMO SPILL. THEY HAVE PULLED ALL THEIR CURRENT STOCK AND ARE REQUESTING TO REPLENISH WITH A NEW LOT NUMBER. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907684 ↗
• MalfunctionAug 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A CLAVE¿ CONNECTOR GENERATED A LEAK DURING PATIENT USE. THE REPORTER STATED THAT THE NURSES ARE SAYING THE PLUNGER IS NOT MOVING AND CAUSING A CHEMO LEAK WITH THIS LOT NUMBER. THEY HAVE PULLED ALL THEIR CURRENT STOCK AND ARE REQUESTING TO REPLENISH WITH A NEW LOT NUMBER. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907270 ↗
• MalfunctionAug 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON AN UNSPECIFIED DATE, THE PORT OF A CLAVE¿ CONNECTOR WAS REPORTEDLY LEAKING AN UNSPECIFIED FLUID. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849489 ↗
• InjuryAug 19, 2025Crack; Crack

  EVENT OCCURRED REGARDING A CLAVE® CONNECTOR WHERE THE CUSTOMER REPORTED THAT THE CENTRAL VENOUS LINE AT THE CONNECTION FOR THE PRESSOR MEDICATION WAS BROKEN. THE CUSTOMER REPORTED AN ACUTE DROP IN BLOOD PRESSURE (SPECIFICS NOT PROVIDED) AT 10:50AM FOR A PATIENT THAT IS HEMODYNAMICALLY UNSTABLE IN INTENSIVE CARE UNIT (ICU) ON PRESSOR MANAGEMENT AND CONTINUOUS VENO-VENOUS HEMOFILTRATION (CVVH). THE CUSTOMER STATED THAT THEY ADJUSTED THE ARTERIAL BLOOD PRESSURE WAVEFORM AS APPROPRIATE I.E., RE-LEVELED, FLUSHED, AND RE-ZEROED BUT THERE WAS CONTINUED DROP IN BLOOD PRESSURE AFTER ADJUSTMENTS. THE PATIENT CONTINUED TO BE ALERT AND ORIENTATED. THEY ADJUSTED THE LINES AS NEEDED AND BLOOD PRESSURE MEDICATION RECONNECTED, SO THE PATIENT'S BLOOD PRESSURE INCREASED APPROPRIATELY.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 22841462 ↗
• InjuryAug 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED REGARDING A CLAVE® CONNECTOR WHERE THEY REPORTED THAT WHILE CHANGING THE TUBING ON PATIENT'S CENTRAL LINE, THE BRAND NEW CLAVE WAS FAULTY AND LEAKING IV FLUID ONTO PATIENT BED INSTEAD OF DELIVERING MEDICATION. AT THE TIME, THE PATIENT WAS RECEIVING VASOACTIVE MEDICATIONS RESULTING IN HYPOTENSION AND ESCALATION OF VASOACTIVE MEDICATIONS PRIOR TO DISCOVERY OF DEFECT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 22804066 ↗
• MalfunctionJul 15, 2025Particulates; Particulates

  IT WAS REPORTED THAT THE CLAVE CONNECTORS HAVE BEEN INVOLVED IN AN ONGOING PARTICULATE MATTER ISSUE RESULTING IN THE CONTAMINATION OF THE FINISHED DRUG PRODUCT. THE REPORTER STATED THAT THE MATERIAL PURCHASED WAS INVOLVED IN AN ONGOING INVESTIGATION INTO PARTICULATES OBSERVED IN THE FINAL DRUG PRODUCT FOR LONZA. THEY HAVE IDENTIFIED THESE PARTICULATES IN THEIR FINAL DRUG PRODUCT AS CELLULOSE/LIGNIN, CELLULOSE FIBER, POLYPROPYLENE, POLYETHYLENE, PVDF-HFP, TEXTILE COTTON FIBER, TEXTILE POLYESTER FIBER, EVA, INDIGO CELLULOSE OR COTTON FIBER, AND FLUOROCARBON-BASED MATERIAL. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22513797 ↗
• MalfunctionMay 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CLAVE¿ CONNECTOR WHERE IT WAS REPORTED THAT PORT CONNECTORS WERE LEAKING. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO INJURIES OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976126 ↗
• MalfunctionJul 24, 2024Infusion or Flow Problem; Infusion or Flow Problem

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CLAVE¿ CONNECTOR. THE CUSTOMER REPORTED DIFFICULTIES/MALFUNCTIONS WITH POSSIBLE LOT NUMBERS #13906163 AND #13869268. AN EMERGENCY ROOM (ER) NURSE REPORTED THAT WHEN THE CLAVE WAS HOOKED UP TO A STOPCOCK ON A SYRINGE, IT WASN'T ALLOWING HIM TO DRAW BACK THE SYRINGE. THE NURSE STATED THAT WAS ALMOST LIKE IT WAS CREATING A VACUUM AND NOT ALLOWING ANY CONTROL OVER PUSHING THE SYRINGE WITH AN UNSPECIFIED MEDICATION THAT NEEDS TO BE PUSHED OVER A CERTAIN AMOUNT OF TIME. THE NURSE WAS ABLE TO FIGURE OUT THAT IF HE PUTS THE CLAVE ONTO THE STOPCOCK AT JUST THE RIGHT ANGLE THEN THE DEVICE WILL ALLOW HIM TO DO WHAT HE NEEDS TO DO CORRECTLY. THERE WAS NO REPORT OF HUMAN HARM ASSOCIATED WITH THIS COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817437 ↗
• MalfunctionJan 21, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THIS EVENT IS ASSOCIATED WITH USER FACILITY MEDWATCH NUMBER MW5091784. THE EVENT INVOLVED A CLAVE CONNECTOR WHERE THE INSIDE STOPPER REMAINED DEPRESSED AND RESULTED IN A LEAK OF CHEMOTHERAPY, TAXOL, ONTO THE PATIENT'S SKIN. THE LEAK OCCURRED ON THE TOP OF THE CLAVE WHERE IT CONNECTS TO THE TUBING. THE PATIENT WAS PROPERLY HANDLED AND SKIN WASHING OCCURRED.

  Patient problems: Chemical Exposure

  MAUDE report 9612085 ↗

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-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-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-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-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-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
• 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-0672-2014 · Dec 24, 2013 · Terminated
  8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. A1069 The ICU Needleless Connector is a single use, sterile, non-pyr
• 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-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-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-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-0700-2014 · Dec 24, 2013 · Terminated
  5" (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. Z3845 The ICU Needleless Connector is a single use, sterile, non-pyrogenic
• 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-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

…and 37 more.