SURFLO SV*21BLKRecalls & reported problems
Terumo Corporation · Surflo Winged Infusion Set · Class 2
Data updated Oct 16, 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 34987350726163), received between Mar 20, 2025 and Mar 20, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Increase in Suction” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Increase in Suction2
- Suction Problem2
Patient problems
- Extravasation2
- Rupture2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2025Increase in Suction; Suction Problem; Increase in Suction; Suction Problem
THE USER FACILITY REPORTED THAT WHILE DRAWING BLOOD THE KIT SUCKED OUT TOO MUCH BLOOD CAUSING THE VESSEL TO RUPTURE. IT DID OCCUR ON MULTIPLE OCCASIONS WITH THE SAME LOT NUMBER DIFFERENT TECHS AND DIFFERENT PATIENTS. THE BLOOD LOSS WAS LESS THAN 250CC. THE REPORTED EVENT DID RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 26FEB2025: SINCE THE PATIENT WAS A FELINE, THE BLOOD LOSS WAS QUITE A SMALL AMOUNT, ROUGHLY WAS LIKELY 0.5ML AND THE VEIN WAS BLOWN.
Patient problems: Extravasation; Rupture
MAUDE report 21652898 ↗MalfunctionMar 20, 2025Increase in Suction; Suction Problem; Increase in Suction; Suction Problem
THE USER FACILITY REPORTED THAT WHILE DRAWING BLOOD THE KIT SUCKED OUT TOO MUCH BLOOD CAUSING THE VESSEL TO RUPTURE. IT DID OCCUR ON MULTIPLE OCCASIONS WITH THE SAME LOT NUMBER DIFFERENT TECHS AND DIFFERENT PATIENTS. THE BLOOD LOSS WAS LESS THAN 250CC. THE REPORTED EVENT DID RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 26FEB2025: SINCE THE PATIENT WAS A FELINE, THE BLOOD LOSS WAS QUITE A SMALL AMOUNT, ROUGHLY WAS LIKELY 0.5ML AND THE VEIN WAS BLOWN.
Patient problems: Extravasation; Rupture
MAUDE report 21652888 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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