ICU Medical CH3340Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840619056216), received between Apr 25, 2025 and Apr 25, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K080989); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2025Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A BAG SPIKE W/CLAVE® ADDITIVE PORT, CLAVE®. IT WAS REPORTED THAT FLUID WAS PREVENTED FROM PASSING THROUGH WHEN ATTACHING HAZARDOUS A INFUSIONS TO THE IV SET WHEN CONNECTED. THERE WAS ALSO POSSIBLE LEAKAGE UPON DISCONNECTION. THE SPIROS PORTS WERE STUCK OPEN ON THE CH3340 (EITHER SPIROS PORT) AFTER DISCONNECTING. THE INTERNAL STOPPER APPEARS TO BE TURNED/MISALIGNED AND IT DOESN¿T SPRING BACK TO CLOSE THE PORT. THEIR PROCESS FOR INFUSIONS IS SENDING THE IV BAG WITH THE CH3340 ATTACHED FROM PHARMACY. NURSING THEN ADDS A CH3034 BAG SPIKE ADAPTER ONTO THE SPIKE OF A REGULAR IV SET AND ADDS A SPINNING SPIROS CLOSED MALE LUER ADAPTER CH2000S TO THE LUER SIDE OF THE IV SET. THEY CONNECT THE CH3034 SPIROS TO THE IN-LINE BAG SPIKE AND THEN ATTACH THE SPINNING SPIROS TO THE ADDITIVE PORT ON THE BAG TO CIRCLE PRIME. THEY HAVE HAD MULTIPLES ISSUES WITH LEAKS FROM EITHER OF THE SPIROS PORTS ON THE CH3340 THAT WERE NOT REACTIVATING WHEN DISCONNECTING CAUSING UNSPECIFIED CHEMOTHERAPY TO SPILL. IN MOST OF THESE SITUATIONS, THE FLUID DOESN¿T PASS THROUGH TO THE LINE, SO THE NURSE GOES TO CHECK OR DETACH FROM THE BAG SPIKE SPILLING AFTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21912871 ↗
• MalfunctionApr 25, 2025Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow

  THE COMPLAINT/EVENT INVOLVED A BAG SPIKE W/CLAVE® ADDITIVE PORT, CLAVE®. IT WAS REPORTED THAT FLUID WAS PREVENTED FROM PASSING THROUGH WHEN ATTACHING HAZARDOUS A INFUSIONS TO THE IV SET WHEN CONNECTED. THERE WAS ALSO POSSIBLE LEAKAGE UPON DISCONNECTION. THE SPIROS PORTS WERE STUCK OPEN ON THE CH3340 (EITHER SPIROS PORT) AFTER DISCONNECTING. THE INTERNAL STOPPER APPEARS TO BE TURNED/MISALIGNED AND IT DOESN¿T SPRING BACK TO CLOSE THE PORT. THEIR PROCESS FOR INFUSIONS IS SENDING THE IV BAG WITH THE CH3340 ATTACHED FROM PHARMACY. NURSING THEN ADDS A CH3034 BAG SPIKE ADAPTER ONTO THE SPIKE OF A REGULAR IV SET AND ADDS A SPINNING SPIROS CLOSED MALE LUER ADAPTER CH2000S TO THE LUER SIDE OF THE IV SET. THEY CONNECT THE CH3034 SPIROS TO THE IN-LINE BAG SPIKE AND THEN ATTACH THE SPINNING SPIROS TO THE ADDITIVE PORT ON THE BAG TO CIRCLE PRIME. THEY HAVE HAD MULTIPLES ISSUES WITH LEAKS FROM EITHER OF THE SPIROS PORTS ON THE CH3340 THAT WERE NOT REACTIVATING WHEN DISCONNECTING CAUSING UNSPECIFIED CHEMOTHERAPY TO SPILL. IN MOST OF THESE SITUATIONS, THE FLUID DOESN¿T PASS THROUGH TO THE LINE, SO THE NURSE GOES TO CHECK OR DETACH FROM THE BAG SPIKE SPILLING AFTER DISCONNECTION, AND ADDITIONALLY TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21912673 ↗
• MalfunctionApr 25, 2025Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow

  THE COMPLAINT/EVENT INVOLVED A BAG SPIKE W/CLAVE® ADDITIVE PORT, CLAVE®. IT WAS REPORTED THAT FLUID WAS PREVENTED FROM PASSING THROUGH WHEN ATTACHING HAZARDOUS A INFUSIONS TO THE IV SET WHEN CONNECTED. THERE WAS ALSO POSSIBLE LEAKAGE UPON DISCONNECTION. THE SPIROS PORTS WERE STUCK OPEN ON THE CH3340 (EITHER SPIROS PORT) AFTER DISCONNECTING. THE INTERNAL STOPPER APPEARS TO BE TURNED/MISALIGNED AND IT DOESN T SPRING BACK TO CLOSE THE PORT. THEIR PROCESS FOR INFUSIONS IS SENDING THE IV BAG WITH THE CH3340 ATTACHED FROM PHARMACY. NURSING THEN ADDS A CH3034 BAG SPIKE ADAPTER ONTO THE SPIKE OF A REGULAR IV SET AND ADDS A SPINNING SPIROS CLOSED MALE LUER ADAPTER CH2000S TO THE LUER SIDE OF THE IV SET. THEY CONNECT THE CH3034 SPIROS TO THE IN-LINE BAG SPIKE AND THEN ATTACH THE SPINNING SPIROS TO THE ADDITIVE PORT ON THE BAG TO CIRCLE PRIME. THEY HAVE HAD MULTIPLES ISSUES WITH LEAKS FROM EITHER OF THE SPIROS PORTS ON THE CH3340 THAT WERE NOT REACTIVATING WHEN DISCONNECTING CAUSING UNSPECIFIED CHEMOTHERAPY TO SPILL. IN MOST OF THESE SITUATIONS, THE FLUID DOESN¿T PASS THROUGH TO THE LINE, SO THE NURSE GOES TO CHECK OR DETACH FROM THE BAG SPIKE SPILLING AFTER DISCONNECTION, AND ADDITIONALLY TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21912376 ↗
• MalfunctionApr 25, 2025Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow

  THE COMPLAINT/EVENT INVOLVED A BAG SPIKE W/CLAVE® ADDITIVE PORT, CLAVE®. IT WAS REPORTED THAT FLUID WAS PREVENTED FROM PASSING THROUGH WHEN ATTACHING HAZARDOUS A INFUSIONS TO THE IV SET WHEN CONNECTED. THERE WAS ALSO POSSIBLE LEAKAGE UPON DISCONNECTION. THE SPIROS PORTS WERE STUCK OPEN ON THE CH3340 (EITHER SPIROS PORT) AFTER DISCONNECTING. THE INTERNAL STOPPER APPEARS TO BE TURNED/MISALIGNED AND IT DOESN'T SPRING BACK TO CLOSE THE PORT. THEIR PROCESS FOR INFUSIONS IS SENDING THE IV BAG WITH THE CH3340 ATTACHED FROM PHARMACY. NURSING THEN ADDS A CH3034 BAG SPIKE ADAPTER ONTO THE SPIKE OF A REGULAR IV SET AND ADDS A SPINNING SPIROS CLOSED MALE LUER ADAPTER CH2000S TO THE LUER SIDE OF THE IV SET. THEY CONNECT THE CH3034 SPIROS TO THE IN-LINE BAG SPIKE AND THEN ATTACH THE SPINNING SPIROS TO THE ADDITIVE PORT ON THE BAG TO CIRCLE PRIME. THEY HAVE HAD MULTIPLES ISSUES WITH LEAKS FROM EITHER OF THE SPIROS PORTS ON THE CH3340 THAT WERE NOT REACTIVATING WHEN DISCONNECTING CAUSING UNSPECIFIED CHEMOTHERAPY TO SPILL. IN MOST OF THESE SITUATIONS, THE FLUID DOESN'T PASS THROUGH TO THE LINE, SO THE NURSE GOES TO CHECK OR DETACH FROM THE BAG SPIKE SPILLING AFTER DISCONNECTION, AND ADDITIONALLY TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21912170 ↗
• MalfunctionApr 25, 2025Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow

  THE COMPLAINT/EVENT INVOLVED A BAG SPIKE W/CLAVE® ADDITIVE PORT, CLAVE®. IT WAS REPORTED THAT FLUID WAS PREVENTED FROM PASSING THROUGH WHEN ATTACHING HAZARDOUS A INFUSIONS TO THE IV SET WHEN CONNECTED. THERE WAS ALSO POSSIBLE LEAKAGE UPON DISCONNECTION. THE SPIROS PORTS WERE STUCK OPEN ON THE CH3340 (EITHER SPIROS PORT) AFTER DISCONNECTING. THE INTERNAL STOPPER APPEARS TO BE TURNED/MISALIGNED AND IT DOESN¿T SPRING BACK TO CLOSE THE PORT. THEIR PROCESS FOR INFUSIONS IS SENDING THE IV BAG WITH THE CH3340 ATTACHED FROM PHARMACY. NURSING THEN ADDS A CH3034 BAG SPIKE ADAPTER ONTO THE SPIKE OF A REGULAR IV SET AND ADDS A SPINNING SPIROS CLOSED MALE LUER ADAPTER CH2000S TO THE LUER SIDE OF THE IV SET. THEY CONNECT THE CH3034 SPIROS TO THE IN-LINE BAG SPIKE AND THEN ATTACH THE SPINNING SPIROS TO THE ADDITIVE PORT ON THE BAG TO CIRCLE PRIME. THEY HAVE HAD MULTIPLES ISSUES WITH LEAKS FROM EITHER OF THE SPIROS PORTS ON THE CH3340 THAT WERE NOT REACTIVATING WHEN DISCONNECTING CAUSING UNSPECIFIED CHEMOTHERAPY TO SPILL. IN MOST OF THESE SITUATIONS, THE FLUID DOESN¿T PASS THROUGH TO THE LINE, SO THE NURSE GOES TO CHECK OR DETACH FROM THE BAG SPIKE SPILLING AFTER DISCONNECTION, AND ADDITIONALLY TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21912014 ↗
• MalfunctionApr 25, 2025Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow

  THE COMPLAINT/EVENT INVOLVED A BAG SPIKE W/CLAVE® ADDITIVE PORT, CLAVE®. IT WAS REPORTED THAT FLUID WAS PREVENTED FROM PASSING THROUGH WHEN ATTACHING HAZARDOUS A INFUSIONS TO THE IV SET WHEN CONNECTED. THERE WAS ALSO POSSIBLE LEAKAGE UPON DISCONNECTION. THE SPIROS PORTS WERE STUCK OPEN ON THE CH3340 (EITHER SPIROS PORT) AFTER DISCONNECTING. THE INTERNAL STOPPER APPEARS TO BE TURNED/MISALIGNED AND IT DOESN¿T SPRING BACK TO CLOSE THE PORT. THEIR PROCESS FOR INFUSIONS IS SENDING THE IV BAG WITH THE CH3340 ATTACHED FROM PHARMACY. NURSING THEN ADDS A CH3034 BAG SPIKE ADAPTER ONTO THE SPIKE OF A REGULAR IV SET AND ADDS A SPINNING SPIROS CLOSED MALE LUER ADAPTER CH2000S TO THE LUER SIDE OF THE IV SET. THEY CONNECT THE CH3034 SPIROS TO THE IN-LINE BAG SPIKE AND THEN ATTACH THE SPINNING SPIROS TO THE ADDITIVE PORT ON THE BAG TO CIRCLE PRIME. THEY HAVE HAD MULTIPLES ISSUES WITH LEAKS FROM EITHER OF THE SPIROS PORTS ON THE CH3340 THAT WERE NOT REACTIVATING WHEN DISCONNECTING CAUSING UNSPECIFIED CHEMOTHERAPY TO SPILL. IN MOST OF THESE SITUATIONS, THE FLUID DOESN¿T PASS THROUGH TO THE LINE, SO THE NURSE GOES TO CHECK OR DETACH FROM THE BAG SPIKE SPILLING AFTER DISCONNECTION, AND ADDITIONALLY TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911751 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080989. One submission often covers many models, so check the product and lot details in each record.

• Z-0710-2021 · Aug 31, 2020 · Open, Classified
  Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260