Alaris, VersaSafe 2177-0000Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Blood Set, 180 Micron Filter Split Septum Y-Site 307 cm (122 in) · Class 2
All models of Alaris, VersaSafe (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613203012652), received between Sep 24, 2019 and Nov 8, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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 Leak1
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient2
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 8, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING LEAKED. IT WAS FURTHER CONFIRMED DURING FOLLOW UP, THAT THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 9297120 ↗MalfunctionSep 24, 2019Material Separation; Material Separation
IT WAS REPORTED THAT THE BLOOD TUBING CAME APART PRIOR TO PATIENT USE. NO HARM TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9109799 ↗
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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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