Alaris 2207-0007Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, 300 cm (118 in) · Class 2
All models of Alaris (85)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885403463952), received between Dec 12, 2018 and Apr 6, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
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
Device problems
- Fluid/Blood Leak2
- Complete Blockage1
- Restricted Flow rate1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate
IT WAS REPORTED THAT THE AS LVP 20D 1.2M WOULDN'T PRIME DUE TO FLOW ISSUES/BLOCKAGE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I'M NOT CERTAIN BUT I BELIEVE THEY HAVE HAD 7 MORE INSTANCES OF THE IV SET NOT PRIMING PAST THE 1.2 MICRON FILTER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11624974 ↗MalfunctionApr 4, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING SET LEAKED AT THE FILTER DURING A TPN INFUSION INFUSING VIA THE PATIENT'S PICC LINE. THE CUSTOMER FURTHER STATED THAT THE "FILTER APPEARED TO BE TIGHTLY ATTACHED TO TPN FLUID LINE BUT THE LINE SEEMED LOOSE ABOVE WHERE THE FILTER SCREWED IN." THERE WERE NO ADVERSE EFFECTS TO THE NEONATE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9926093 ↗MalfunctionDec 12, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE LARGE VOLUME TUBING SET (WITH NO INLINE FILTER) STARTED TO LEAK BELOW THE BLUE HUB AND THAT THE SILICONE PUMPING SEGMENT WAS SPRAYING TPN. ALTHOUGH THERE WAS NO PATIENT HARM, THE CUSTOMER STATES THAT CHANGING THE TUBING SET PUTS THE PATIENT AT AN INCREASED RISK OF INFECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8157294 ↗
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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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