ICU Medical CS-53Recalls & reported problems
Icu Medical, Inc. · Spike with Bonded Clave™ Connector · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840619026011), received between Feb 21, 2025 and Feb 21, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
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
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE COMPLAINT/EVENT INVOLVED A SPIKE WITH BONDED CLAVE® CONNECTOR. PARTICLES AND WHITE DEPOSITS WERE REPORTED IN THE DRIP CHAMBER (BUT WERE NOT VISIBLE IN VIALS/BAGS) WHEN THE DEVICE WAS USED WITH CYCLOPHOSPHAMIDE. THIS CAUSED THE PUMP TO ALARM DURING A PATIENT'S INFUSION AT THE HDJ ONCOLOGY/URC UNIT. TREATMENT NEEDED TO BE DISCONTINUED AS A NEW BAG NEEDED TO BE PREPARED AND RECONNECTED FOR TREATMENT. THE CYCLOPHOSPHAMIDE MANUFACTURER HAS BEEN NOTIFIED AND THEY WILL CONDUCT TESTS TO IDENTIFY A POSSIBLE INCOMPATIBILITY. THE CUSTOMER ADDED THAT THE PUMP USED DURING INFUSION WAS A VOLUMAT PUMP AND NO ISSUES WERE OBSERVED WITH THE PUMP. THE MEDICATION USED WAS A TO BE DILUTED BEFORE INJECTION VIAL OF CYCLOPHOSPHAMIDE 1000MG/2 ML FROM REDDY PHARMA. THERE WERE NO HOLES, CUTS, TEAR OR ANY OTHER DEFECT WITH THE SPIKE, THE PATIENT WAS STABLE, NO ONE WAS HARMED DURING THE INCIDENT, ADDITIONAL MEDICAL INTERVENTION WAS NOT REQUIRED, THERE WAS NO BLOOD LOSS, THERE WAS A DELAY IN TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21434080 ↗
Other Stopcock, i.V. Set devices
- Connecta, Luer-Lok 394910BD Switzerland Sàrl · Stopcock, i.V. Set3 recalls8 reports
- Outlook® 490361B. Braun Medical Inc. · Stopcock, i.V. Set3 recalls0 reports
- Blood Administration Set 490530B. Braun Medical Inc. · Stopcock, i.V. Set2 recalls11 reports
- Medex MX9341LIcu Medical, Inc. · Stopcock, i.V. Set63 reports
- ICU Medical AC135Icu Medical, Inc. · Stopcock, i.V. Set1 recall10 reports
- IV Administration Set 490067B. Braun Medical Inc. · Stopcock, i.V. Set1 recall9 reports
- ICU Medical MC330174Icu Medical, Inc. · Stopcock, i.V. Set1 recall4 reports
- ICU Medical Z2587Icu Medical, Inc. · Stopcock, i.V. Set1 recall3 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page