ICU Medical CH3661Recalls & reported problems
Icu Medical, Inc. · 14" (36 cm) Appx 4.3 ml, Bifuse Add-On Set w/Bag Spike, Spiros™ w/Red Cap, 2 Clamps (Blue, Red), Vented Cap, Drop-In Spiros™ w/Red Cap · 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 00887709086883), received between Nov 24, 2025 and Nov 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
1 other recall cover devices cleared under the same FDA submission (K070532); 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
- Material Separation1
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.
MalfunctionNov 24, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
EVENT OCCURRED REGARDING TO 14" (36 CM) APPX 4.3 ML, BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS W/RED CAP, 2 CLAMPS (BLUE, RED), VENTED CAP, DROP-IN SPIROS W/RED CAP WHERE IT WAS REPORTED THAT THE SPIROS THAT ATTACHED TO THE BIFUSE (NOT THE SPINNING ONE AT THE BOTTOM), CAME PARTIALLY DETACHED AND WAS ABLE TO MOVE UP AND DOWN ON THE TUBING WHEN IT¿S USUALLY FIXED IN PLACE. THEY ALSO REPORTED CHEMO LEAKED DUE TO THIS SEPARATION. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND THERE WAS DELAY IN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23639143 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K070532. One submission often covers many models, so check the product and lot details in each record.
- Z-0699-2021 · Aug 31, 2020 · Open, Classified42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, RE
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- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 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.
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