Caresite® 470101Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 04046964183874), received between Nov 21, 2016 and Feb 20, 2026 — classified as 44 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (21 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 3: "THE PRODUCT IS BACK FLOWING TERRIBLY AND MAKING A MESS. I ORDERED THE STANDARD BORE AND SMALL BORE AND THE SAME PROBLEM HAPPENED WITH BOTH. I'VE USED 3 OUT OF EACH BOX TO MAKE SURE IT WASN'T JUST ONE BAD SET. A NURSE ALSO TRIED AND HAD THE SAME ISSUE." "IT'S BACK FLOW OF BLOOD. I DISCONNECTED THE LINE, CLAMPED IT, AND THE BLOOD CAME FLOWING OUT OF END OF THE EXTENSION SET ONTO THE PATIENTS CLOTHING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406314 ↗
• MalfunctionFeb 20, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: "THE PRODUCT IS BACK FLOWING TERRIBLY AND MAKING A MESS. I ORDERED THE STANDARD BORE AND SMALL BORE, AND THE SAME PROBLEM HAPPENED WITH BOTH. I'VE USED 3 OUT OF EACH BOX TO MAKE SURE IT WASN'T JUST ONE BAD SET. A NURSE ALSO TRIED AND HAD THE SAME ISSUE." "IT'S BACK FLOW OF BLOOD. I DISCONNECTED THE LINE, CLAMPED IT, AND THE BLOOD CAME FLOWING OUT OF END OF THE EXTENSION SET ONTO THE PATIENTS CLOTHING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406309 ↗
• MalfunctionFeb 20, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: "THE PRODUCT IS BACK FLOWING TERRIBLY AND MAKING A MESS. I ORDERED THE STANDARD BORE AND SMALL BORE AND THE SAME PROBLEM HAPPENED WITH BOTH. I'VE USED 3 OUT OF EACH BOX TO MAKE SURE IT WASN'T JUST ONE BAD SET. A NURSE ALSO TRIED AND HAD THE SAME ISSUE." "IT'S BACK FLOW OF BLOOD. I DISCONNECTED THE LINE, CLAMPED IT, AND THE BLOOD CAME FLOWING OUT OF END OF THE EXTENSION SET ONTO THE PATIENTS CLOTHING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406245 ↗
• MalfunctionJun 7, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: CRACKED EXTENSION TUBING. DETAILED INQUIRY DESCRIPTION PIV RUNNING FINE DURING THE DAY UNTIL FLUSH WAS RUNNING THROUGH PIV AND FOUND BLOOD BACKING UP FROM PIV SITE AND SMALL AMOUNT OF BLOOD MIXED WITH IV FLUID (STARTER 10%) AND FLUSH FOUND ON PATIENT'S BEDSIDE (NEST). SOON AFTER IT WAS NOTED, CLAMPED PIV CLOSEST TO PATIENT AND STOPPED ALL IV FLUIDS RUNNING THROUGH PIV. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484025 ↗
• MalfunctionNov 29, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: LEAKING EXTENSION SET. DETAILED INQUIRY DESCRIPTION. EXTENSION SET GREEN HUB CRACKED AND LEAKED BLOOD. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18226792 ↗
• MalfunctionMar 27, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE GREEN CONNECTOR PIECE HAS CRACKED CAUSING BLOOD TO BLEED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618549 ↗
• MalfunctionJan 10, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT THE GREEN CONNECTOR BROKE AND BLOOD LEAKED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134228 ↗
• MalfunctionJan 3, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY, EVENT 3, DESCRIPTION OF THE PATIENT EVENT: "THIS EXTENSION SET AT THE END OF THE ARTERIAL LINES FOR PED CASES BUT LATELY THERE HAVE BEEN AT LEAST 3 CASES THAT I REMEMBER WHERE THE TUBING CRACKS AND THE LINE STARTS BLEEDING OUT.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16091362 ↗
• MalfunctionJan 3, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: DESCRIPTION OF THE PATIENT EVENT: "THIS EXTENSION SET AT THE END OF THE ARTERIAL LINES FOR PED CASES BUT LATELY THERE HAVE BEEN AT LEAST 3 CASES THAT I REMEMBER WHERE THE TUBING CRACKS AND THE LINE STARTS BLEEDING OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16091332 ↗
• MalfunctionJan 3, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: DESCRIPTION OF THE PATIENT EVENT: "THIS EXTENSION SET AT THE END OF THE ARTERIAL LINES FOR PED CASES BUT LATELY THERE HAVE BEEN AT LEAST 3 CASES THAT I REMEMBER WHERE THE TUBING CRACKS AND THE LINE STARTS BLEEDING OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16091320 ↗
• MalfunctionDec 13, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: LEAKING FROM LEUR ACCESS DEVICE. INFUSION FLUID: OXALIPLATIN. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15971475 ↗
• MalfunctionNov 10, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: CUSTOMER REPORTED LEAKING FROM EXTENSION SET. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15769532 ↗
• MalfunctionOct 4, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: DETAILED INQUIRY DESCRIPTION: IT WAS NOTED HUB OF EXTENSION SET WAS CRACKED AND LEAKING BLOOD ON THE TABLE. EXTENSION SET WAS REPLACED WITH A NEW 470101 AND WAS NOTED DAYS LATER IN THE ICU THAT THE HUB WAS CRACKED IN THE SAME SPOT. NO INJURY REPORTED. TO NOTE, TWO POSSIBLE LOT NUMBERS PROVIDED: LOT NUMBER 0061823202 - EXPIRY DATE 03/31/2025; PRODUCTION DATE 04/07/2022, LOT NUMBER 0061778799 - EXPIRY DATE 03/31/2024; PRODUCTION DATE 04/20/2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538608 ↗
• MalfunctionOct 4, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: DETAILED INQUIRY DESCRIPTION: IT WAS NOTED HUB OF EXTENSION SET WAS CRACKED AND LEAKING BLOOD ON THE TABLE. EXTENSION SET WAS REPLACED WITH A NEW 470101 AND WAS NOTED DAYS LATER IN THE ICU THAT THE HUB WAS CRACKED IN THE SAME SPOT. NO INJURY REPORTED. TO NOTE, TWO POSSIBLE LOT NUMBERS PROVIDED: LOT NUMBER: 0061823202 - EXPIRY DATE 03/31/2025; PRODUCTION DATE 04/07/2022. LOT NUMBER: 0061778799 - EXPIRY DATE 03/31/2024; PRODUCTION DATE 04/20/2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538597 ↗
• MalfunctionAug 22, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: LEAKAGE FROM GREEN HUB WHEN INFUSION ONCOLOGY DRUGS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15265061 ↗
• MalfunctionJul 22, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: LEAKAGE (RED MARK) DURING THERAPY WITH INFUSION SET. CAN BE SEEN THAT LEAKAGE OF BLOOD OCCURRED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15085048 ↗
• MalfunctionJul 22, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: LEAKAGE (RED MARK) DURING THERAPY WITH INFUSION SET. CAN BE SEEN THAT LEAKAGE OF BLOOD OCCURRED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15085014 ↗
• MalfunctionOct 11, 2021Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT UPON DRAWING BLOOD FROM THE PATIENT, THE GREEN HUB LEAKED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12605904 ↗
• MalfunctionOct 11, 2021Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT UPON DRAWING BLOOD FROM THE PATIENT, THE GREEN HUB LEAKED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12605900 ↗
• MalfunctionSep 15, 2021Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: BLOOD LEAKAGE OCCURRED FROM GREEN HUB AFTER ONCOLOGY THERAPY. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12473328 ↗
• MalfunctionSep 15, 2021Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: LEAKAGE OCCURRED FROM GREEN HUB WHEN FLUSHING NORMAL SALINE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12473327 ↗
• MalfunctionJun 9, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: "CRACK IN GREEN HUB OF EXTENSION SET. NURSE FOUND A SMALL NON-VISIBLE CRACK IN THE GREEN PART. IT WASN'T CAUGHT UNTIL AN HOUR LATER WHEN THE NURSE WALKED BACK INTO THE PATIENT'S ROOM AND THERE WAS A SIGNIFICANT AMOUNT OF BLOOD POOLING ON THE PATIENTS GOWN, AND ON THE GROUND. WHEN THE NURSE FLUSHED THE LINE, THE SALINE WAS SQUIRTING OUT OF THE CRACK. THE PATIENTS ARM IS CONTRACTED SO HE WASN'T MOVING IT." NO INJURY REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11970484 ↗
• MalfunctionApr 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: REPORT STATES, "CARESITE CRACKING LEAKING AND NURSES ARE "GETTING SPLATTERED WITH BLOOD". NO INJURY REPORTED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 11619134 ↗
• MalfunctionNov 13, 2020Fluid/Blood Leak; Fluid/Blood Leak

  EVENT 2: AS REPORTED BY THE USER FACILITY: "THE CONNECTION CAME APART DURING POWER INJECTIONS. THE CONNECTION CAME APART AFTER MOST OF THE INJECTION WAS COMPLETED. THE INSTANCE INVOLVED SOME BLOOD TO RETURN AND CREATED A POTENTIAL EXPOSURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10837849 ↗
• MalfunctionNov 13, 2020Fluid/Blood Leak; Fluid/Blood Leak

  EVENT 1: AS REPORTED BY THE USER FACILITY: "THE CONNECTION CAME APART DURING POWER INJECTIONS. THE CONNECTION CAME APART AFTER MOST OF THE INJECTION WAS COMPLETED. THE INSTANCE INVOLVED SOME BLOOD TO RETURN AND CREATED A POTENTIAL EXPOSURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10837819 ↗