ICU Medical SMV32Recalls & reported problems
Icu Medical, Inc. · 2 Gang 1o2™ Manifold, Rotating Luer · 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 00887709042032), received between May 21, 2024 and May 21, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Backflow” (1 report).
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
- Backflow1
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.
MalfunctionMay 21, 2024Backflow; Backflow
THE EVENT INVOLVED A 2 GANG 1O2® MANIFOLD, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE SEAL DIDN'T WORK SO FLUID WENT BACK UP INTO THE FENTANYL SYRINGE. THE OTHER DEVICES THAT WERE ATTACHED TO THE MONIFOLD ARE PRIMARY PLUM IVF SET AND EXTENSION SET 31INCH. THE MANUFACTURER AND BRAND NAME OF THE SYRINGE IS BECTON, DICKINSON AND COMPANY / BD PLASTIPAK 5ML SYRINGE. THERE WAS PATIENT INVOLVEMENT BUT NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19367254 ↗
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-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
- 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
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- 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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