ICU Medical SMV3V3Recalls & reported problems
Icu Medical, Inc. · 3-Gang 1o2™ Manifold w/Back Check Valve, Rotating Luer · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709042087), received between May 14, 2024 and May 17, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).
3 other recalls cover devices cleared under the same FDA submission (K974589); 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 Leak4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 17, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A 3-GANG 1O2® MANIFOLD W/BACK CHECK VALVE, ROTATING LUER GENERATED A LEAK DURING PATIENT USE. THE REPORT STATES THAT THEY HAVE EXPERIENCED LEAKING WITH THE PRODUCT. NO PHYSICAL DEFECTS WERE NOTED PRIOR TO USE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19347896 ↗MalfunctionMay 17, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A 3-GANG 1O2® MANIFOLD W/BACK CHECK VALVE, ROTATING LUER WHERE THE CUSTOMER REPORTED A LEAK. NO PHYSICAL DEFECTS NOTED PRIOR TO USE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19342414 ↗MalfunctionMay 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 3-GANG 1O2® MANIFOLD W/BACK CHECK VALVE, ROTATING LUER WHERE IT WAS REPORTED THERE WAS LEAKING WITH THE PRODUCT. NO PHYSICAL DEFECTS NOTED PRIOR TO USE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19331048 ↗MalfunctionMay 14, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 3-GANG 1O2® MANIFOLD W/BACK CHECK VALVE, ROTATING LUER. LEAKAGE WITH THIS PRODUCT WAS REPORTED. NO PHYSICAL DEFECTS NOTED PRIOR TO USE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS COMPLAINT/EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19315793 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K974589. One submission often covers many models, so check the product and lot details in each record.
- Z-3160-2026 · May 12, 2026 · Open, ClassifiedIV Sets with drip chambers
- Z-0252-2021 · Jul 6, 2020 · Terminated120 IN (305cm)APPX 15.4ml, 10 DROP, 2 Clave STOPCOCK, NanoClave T-Connector, 2 CHECK VALVES. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040141(17)250101(30)25(10)45736
- Z-0257-2021 · Jul 6, 2020 · Terminated98 IN (249cm) APPX 8.4 ml, 60 Drop Set, 2 Clave, REMV 2 Clave STOPCOCKS. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709076119(17)250101(30)25(10)4584862. The SmartValve i
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- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- 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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