Caresite Micro™ 415400Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04046955781881), received between Apr 24, 2025 and Jun 2, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: IN THE NICU, "CLAVES" ARE USED AT THE END OF OUR TUBING DEVICES THAT ALLOW US TO ATTACH A LUER-LOCK SYRINGE TO FLUSH/ADMINISTER, ETC. THERE IS A NEW "CLEAR" CLAVE PRODUCT THAT IS BEING STOCKED ON THE FLOOR (THE PRIOR CLAVE WAS "GREEN). RN HAS NOTED ON MULTIPLE OCCASIONS WHERE THE PLUNGER INSIDE OF THE CLAVE (WHICH SEEMS TO BE SPRING OPERATED) HAS NOT SPRUNG BACK UP/HAS STAYED DOWN IN AN ENGAGED POSITION. TYPICALLY, WHEN ATTACHING A SYRINGE TO THE CLAVE, YOU HAVE TO PUSH IN AND TWIST, AND THE PUSH IN MECHANISM IS STUCK IN PLACE. THIS ENCOUNTER OF A MALFUNCTIONED CLAVE CAUSED A LARGE AIR BUBBLE TO BE IN MY MED-LINE ATTACHED TO THE CLAVE, THAT IS ATTACHED TO AN UMBILICAL CENTRAL LINE. RN WAS AWARE OF AIR BUBBLE AND INTERVENED BEFORE IT REACHED THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25361180 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: EVENT 1: SINCE CS MICRO ROLLED OUT, 2 CLABSI'S REPORTED IN THE NICU IN SEPTEMBER AND OCTOBER. HAVEN'T HAD ANY REPORTED CLABSI IN NICU IN 1500 DAYS.

  Patient problems: Bacterial Infection

  MAUDE report 23656244 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: EVENT 2: SINCE CS MICRO ROLLED OUT, 2 CLABSI'S REPORTED IN THE NICU IN SEPTEMBER AND OCTOBER. HAVEN'T HAD ANY REPORTED CLABSI IN NICU IN 1500 DAYS.

  Patient problems: Bacterial Infection

  MAUDE report 23656243 ↗
• MalfunctionNov 19, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DURING THERAPY PLUNGER IN THE HOUSING IS STAYING DOWN AND BLOOD IS POURING OUT. NO INJURY REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23594379 ↗
• MalfunctionMay 22, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION EX C - BLOOD OUTSIDE FLUID PATH. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071393 ↗
• MalfunctionMay 16, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: EX E - CONDENSATION OBSERVED IN CMV. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035080 ↗
• MalfunctionMay 16, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION EX D - BLOOD OUTSIDE FLUID PATH. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034980 ↗
• MalfunctionMay 7, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION CONDENSATION WAS NOTED IN CARESITE MICRO VALVE ON CURRENT PATIENT. I WAS TAKEN IN THE ROOM AND NOTED THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21980538 ↗
• MalfunctionMay 5, 2025Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: CHEMO LEAKED FROM EXTENSION SET ONTO PATIENT. DETAILED INQUIRY DESCRIPTION: PATIENTS EXTENSION SET SEPARATED FROM THE PIV AND BLOOD AND CHEMO LEAKED ONTO PATIENT. PATIENT HAD DOCETAXEL CHEMOTHERAPY INFUSING WHEN THE CAP ON THE IV CATHETER BECAME DISCONNECTED FROM THE EXTENSION TUBING ON THE PATIENT'S PIV. PATIENT'S PIV THEN BACK FLOWED BLOOD ALL OVER THE PATIENT, THE INFUSION CHAIR, AND THE FLOOR. THE CHEMOTHERAPY THAT WAS INFUSING WHEN THE CAP BECAME DETACHED, LEAKED ONTO THE PATIENT'S SKIN, THE INFUSION CHAIR, AND THE FLOOR. PATIENT PUT ON HER CALL LIGHT WHEN SHE NOTICED HER IV WAS BLEEDING. WHEN WRITER WALKED IN THE ROOM, IMMEDIATELY CLAMPED PATIENT'S PIV TO STOP IT FROM FURTHER BLEEDING AND STOPPED THE PATIENT'S INFUSION PUMP TO STOP FURTHER CHEMOTHERAPY FROM LEAKING ALL OVER. CHEMO SPILL KIT WAS THEN OBTAINED, AND THE CHEMOTHERAPY WAS CLEANED UP PER PROTOCOL. CLEANED UP THE BLOOD ON THE PATIENT, CHAIR, AND FLOOR, AND WASHED PATIENT'S ARM WITH SOAPY WIPES WHERE THE CHEMOTHERAPY CAME INTO CONTACT WITH HER SKIN. OFFERED PATIENT HOSPITAL GOWN AND PANTS TO WEAR. AFTER CHEMO AND BLOOD CLEAN UP. INFUSION WAS RESTARTED WITH

  Patient problems: Chemical Exposure

  MAUDE report 21961466 ↗
• MalfunctionApr 28, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: STATES LEAKING AT STOPCOCK, CARESITE MICRO DIFFICULT TO REMOVE, HARD TO PUT ON, BLOOD AT BASE OF CARESITE MICRO ON LAB DRAWS. DETAILED INQUIRY DESCRIPTION: SET UP BELOW DEMO- STATES LEAKING AT STOPCOCK, CARESITE MICRO DIFFICULT TO REMOVE, HARD TO PUT ON, BLOOD AT BASE OF CARESITE MICRO ON LAB DRAWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917067 ↗
• MalfunctionApr 24, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION "PRECIPITANT" IN VALVE. DETAILED INQUIRY DESCRIPTION: 4TH FLOOR PICU STATES THEY SEE "PRECIPITANT" IN VALVE (CARESITE MICRO) NOTED FREQUENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903748 ↗