ICU Medical CH-14Recalls & reported problems
Icu Medical, Inc. · ChemoClave® Vented Bag Spike · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This ICU Medical ChemoClave vented bag spike has 130 adverse event reports on record, with no deaths and no injuries. The reports mostly describe chemotherapy drug leaking from the vent or spike during infusion, and some mention no flow. Some report chemical exposure, and most describe no clinical signs. The last 12 months show 18 reports, compared with 45 in the 12 months before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 134
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 134 adverse event reports that list this exact device (DI 00840619023751), received between Oct 24, 2018 and Sep 18, 2026 — classified as 134 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (82 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak82
- No Flow26
- Air/Gas in Device10
- Particulates5
- Failure to Infuse4
- Device Contamination with Chemical or Other Material3
- Break2
- Infusion or Flow Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions89
- Chemical Exposure43
- No Consequences Or Impact To Patient43
Recent adverse event reports
The 25 most recent of 134 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828519 ↗MalfunctionSep 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780076 ↗MalfunctionSep 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780042 ↗MalfunctionSep 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779396 ↗MalfunctionSep 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776878 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714191 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
The event involved a ChemoClave Vented Bag Spike. It was stated in the report that Leakaged from air vent. Event was noted during drug preparation. An unknown chemo drug was involved in the event. There was no bleedback reported. The product is not a biohazard and the device was not reprocessed/resterilized. There was no patient involvement. There was no delay in critical therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50710162 ↗MalfunctionJul 27, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50047753 ↗MalfunctionJul 27, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50047036 ↗MalfunctionJun 9, 2026Fluid/Blood Leak
AN EVENT INVOLVED A CHEMOCLAVE VENTED BAG SPIKE WHERE IT WAS REPORTED THAT CHEMO DRUG LEAKED FROM AIR VENT DURING INFUSION. THERE WAS NO BLEED BACK REPORTED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25441993 ↗MalfunctionJan 27, 2026Air/Gas in Device
AN EVENT INVOLVED A CHEMOCLAVE VENTED BAG SPIKE REPORTED THAT IT ALWAYS HAD AIR IN LINE DURING INFUSION. AN UNKNOWN CHEMO DRUG WAS INVOLVED IN THE EVENT. THERE WAS NO BLEED BACK REPORTED. THE PRODUCT IS NOT A BIOHAZARD, AND THE DEVICE WAS NOT REPROCESSED/RESTERILIZED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. THERE WAS NO DELAY IN CRITICAL THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24186454 ↗MalfunctionJan 26, 2026No Flow
AN INCIDENT INVOLVING A CHEMOCLAVE VENTED BAG SPIKE REPORTED THAT THE CHEMO DRUG COULDN¿T DRIP. THE EVENT OCCURRED DURING INFUSION, AND THE DRUG USED WAS MAVSI. THERE WAS PATIENT INVOLVEMENT, BUT NO DELAY IN CRITICAL THERAPY AND NO ADVERSE EVENT OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24176386 ↗MalfunctionJan 26, 2026No Flow
AN INCIDENT INVOLVING A CHEMOCLAVE VENTED BAG SPIKE STATED THAT CHEMO DRUG COULDN'T DRIP, AND THE SILICON WAS SUNKEN AFTER DISCONNECTION. ENHERTU WAS INVOLVED IN THE EVENT. THERE WAS NO BLEED BACK REPORTED. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24176378 ↗MalfunctionJan 7, 2026Fluid/Blood Leak
THE EVENT INVOLVED A CHEMOCLAVE¿ VENTED BAG SPIKE AND IT WAS THAT DURING INFUSION, LEAKAGE FROM AIR VENT. LIPO-DOX WAS INVOLVED IN THE EVENT. THERE WERE 7 EVENTS OCCURRED. THERE WAS NO DELAY IN CRITICAL THERAPY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23995869 ↗MalfunctionDec 29, 2025No Flow; No Flow
THE EVENT INVOLVED A CHEMOCLAVE VENTED BAG SPIKE WHERE IT WAS REPORTED ERBITUX COULDN'T DRIP. EVENT WAS NOTED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM AND NO DELAY IN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23907806 ↗MalfunctionDec 10, 2025Air/Gas in Device; Air/Gas in Device
AIR WAS REPORTED IN THE PATIENT'S LINE DURING AN INFUSION OF HERCEPTIN AVASTIN WITH A CHEMOCLAVE® VENTED BAG SPIKE. THERE WAS NO PATIENT HARM, NO BLEEDBACK AND NO DELAY IN CRITICAL THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23773439 ↗MalfunctionNov 26, 2025Fluid/Blood Leak; Fluid/Blood Leak
EVENT OCCURRED REGARDING A CHEMOCLAVE VENTED BAG SPIKE WHERE IT WAS STATED IN THE REPORT THAT CHEMO DRUG (BENDAMUSTINE) LEAKAGE FROM BLUE AND WHITE JUNCTION DURING INFUSION. THERE WAS NO BLEEDBACK REPORTED. THE PRODUCT IS NOT A BIOHAZARD, AND THE DEVICE WAS NOT REPROCESSED/RE-STERILIZED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. THERE WAS NO DELAY IN CRITICAL THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23659501 ↗MalfunctionNov 26, 2025No Flow; No Flow
THE EVENT INVOLVED A CHEMOCLAVE® VENTED BAG SPIKE. IT WAS REPORTED THAT CHEMO DRUG COULDN¿T DRIP DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23653565 ↗MalfunctionNov 25, 2025Crack; Crack
THE EVENT INVOLVED A CHEMOCLAVE VENTED BAG SPIKE, AND IT WAS REPORTED THAT THE CHEMOCLAVE IS BROKEN BETWEEN BLUE AND WHITE JUNCTION. THERE WAS NO BLEED BACK REPORTED. HERCEPTIN AND NO CONCOMITANT DEVICE WERE INVOLVED. THERE WAS NO DELAY IN CRITICAL THERAPY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23653357 ↗MalfunctionNov 19, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn
THE CUSTOMER INITIALLY REPORTED AN ISSUE WITH CH3187 (9617594-2025-02025-00) WHERE THE REPORTED PROBLEM WAS LEAK OF PACLITAXEL AND CISPLATIN DURING INFUSION. HOWEVER, THE CUSTOMER ALSO RETURNED A MATING DEVICE SAMPLE FROM CH-14 AND DURING INSPECTION OF THE RETURNED MATING DEVICE SAMPLE, IT WAS NOTED THAT THE ITEM WAS RELATED TO THE CUSTOMER¿S COMPLAINT OF LEAKAGE FOUND ON CH3187. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. THERE WAS NO DELAY IN CRITICAL THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23596555 ↗MalfunctionNov 7, 2025Fluid/Blood Leak; Fluid/Blood Leak
AN EVENT OCCURRED REGARDING A CHEMOCLAVE® VENTED BAG SPIKE, ALLEGING THAT THERE WAS A LEAKAGE OF AN UNKNOWN CHEMOTHERAPY DRUG AT THE JUNCTION BETWEEN THE SPIROS AND THE LOWER TUBING. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM, AND THERE WAS NO DELAY IN CRITICAL THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23500818 ↗MalfunctionNov 6, 2025No Flow; No Flow
AN EMAIL WAS RECEIVED REGARDING A CHEMOCLAVE VENTED BAG SPIKE, ALLEGING AN OCCLUSION DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT AN UNSPECIFIED CHEMO DRUG COULDN'T DRIP DURING INFUSION. THERE WAS NO BLEEDBACK REPORTED. THE PRODUCT IS NOT A BIOHAZARD AND THE DEVICE WAS NOT REPROCESSED/RESTERILIZED. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO DELAY IN CRITICAL THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23493063 ↗MalfunctionOct 30, 2025No Flow; No Flow
EVENT OCCURRED REGARDING A CHEMOCLAVE VENTED BAG SPIKE WHERE THE REPORTER STATED THAT DOCETAXEL COULDN¿T DRIP. THE EVENT OCCURRED DURING INFUSION. THERE WAS NO BLEEDBACK, NO CHEMO, NO BIOHAZARD, NO USER FACILITY MEDWATCH, AND NO DEVICE WAS REPROCESSED/RESTERILIZED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23428627 ↗MalfunctionOct 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
A CHEMOCLAVE® VENTED BAG SPIKE REPORTEDLY LEAKED AN UNSPECIFIED CHEMOTHERAPY DRUG LEAKAGE DURING A PATIENT INFUSION. CISPLATIN AND NO CONCOMITANT DEVICE WERE INVOLVED. THERE WAS NO BLEED BACK REPORTED, NO PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23363851 ↗MalfunctionOct 15, 2025No Flow; No Flow
THE EVENT INVOLVED A CHEMOCLAVE® VENTED BAG SPIKE WHERE A CHEMOTHERAPY DRUG, EPIRUBICIN, COULDN¿T DRIP DURING INFUSION. EPIRUBICIN WAS INVOLVED IN THE EVENT. THERE WAS NO BLEEDBACK REPORTED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. THERE WAS NO DELAY IN CRITICAL THERAPY. THERE WERE TEN QUANTITIES AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23293797 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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