Alaris, SmartSite 24001-0007Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, Back Check Valve Y-Site 120 cm (47 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403238666), received between Sep 22, 2020 and Oct 15, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (1 report).
2 FDA recall records name this device's identifier, 2 still open.
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
Recalls naming this device
- Jul 8, 2025Class IOpen, Classified
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Z-2180-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Oct 11, 2023Class IIOpen, Classified
Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
Z-0349-2024 · Root cause: Error in labeling · Recall details · FDA record ↗
Most reported problems
Device problems
- Complete Blockage1
- Leak/Splash1
- Restricted Flow rate1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Leak/Splash; Leak/Splash
EVENT DETAILS: THE TUBING IS LEAKING AROUND THE LITTLE BLUE CLAP. GETTING AN ERROR MESSAGE THAT THERE IS AIR IN THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23302103 ↗MalfunctionSep 22, 2020Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate
IT WAS REPORTED THAT AS LVP 20D SS CV WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN FILTER BATCH NO: UNKNOWN. IT WAS REPORTED WOULD NOT INFUSE WHILE USING PUMP WITH FILTER. CAN YOU PLEASE PROVIDE IN DETAILS AS TO WHAT REALLY HAPPENED WHEN THE PUMP ALARMED. WHAT MESSAGE DID THE ALARM SHOW (ERROR CODE/MESSAGE)? DID THE PUMP SHUT OFF (BATTERY ISSUE)? ACCORDING TO OUR CLINICAL SITE, ¿OCCLUDED¿ WAS THE ALARM READOUT. THE FOLLOWING IS THE SUMMARY OF WHAT HAPPENED WITH THE PUMP: ¿ON (B)(6) 2020 A IOMAB-B THERAPEUTIC INFUSION WAS PERFORMED FOR PATIENT WITH A FILTER IN THE INFUSION LINE. THE ALARIS PUMP ALARMED SHORTLY AFTER STARTING THE INFUSION, WHICH IS COMMON BASED ON CLAMPING THE LINES, AND THE TEAM WAS ABLE TO ADDRESS THE ALARM AND PROCEED WITH THE INFUSION. WITHIN APPROXIMATELY 30 MINUTES THE PUMP ALARMED AGAIN, AND ALARMS CONTINUED TO OCCUR DESPITE THE TEAM TRYING TO RESOLVE THE SOURCE OF THE ISSUE. THE CLINICAL SITE STAFF EVALUATED THE ISSUE AND SUSPECTED THE ADDITIONAL FILTER TO BE THE SOURCE OF THE PROBLEM. THE INFUSION WAS PAUSED, A SECOND FILTER WAS CAREFULLY BACK-PRIMED AND THE ORIGINAL FILTER AND THE INFUSION RESTARTED. THE
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10570925 ↗
Other Set, administration, intravascular devices
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- 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 · each recall links to the FDA recall notice
- 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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