SURFLO SR-OX1851CARecalls & reported problems
Terumo (Philippines) Corporation · SURFLO IV Catheter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 34806017510184), received between May 24, 2019 and May 24, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Blood Loss1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 24, 2019Break; Break
THE USER FACILITY REPORTED THAT WHEN THE NURSE WAS REMOVING THE SURFLO CATHETER, ONLY THE HUB CAME OUT, THE CATHETER TIP WAS STILL IN THE PATIENT. A SURGEON WAS CONSULTED AND EMERGENCY SURGERY WAS PERFORMED TO REMOVE TIP. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS GOOD. THE TIP WAS REMOVED AND THE VESSEL WAS CORRECTED. ADDITIONAL INFORMATION RECEIVED AS OF MAY 3, 2019: THE CATHETER WAS PLACED APPROXIMATELY 48 HOURS FOR A ROUTINE IV THERAPY. THE PATIENT HAD DIFFICULT VEINS, SO THEY USED AN ULTRASOUND GUIDED APPROACH FOR PLACEMENT, WITH NO ISSUES. THERE WAS NO LEAKAGE NOTED DURING USE. SURGICAL INTERVENTION WAS DONE TO REMOVE THE CATHETER DISTAL TIP WHICH HAD TRAVELED APPROX. 10 CM, STILL WITHIN THE PATIENT'S ARM. THE PATIENT IS STILL IN THE HOSPITAL; HOWEVER SHE WAS EXPECTED TO BE DISCHARGED. TERUMO MEDICAL RECEIVED AN FDA MEDWATCH 5086416 WITH ADDITIONAL INFORMATION ON MAY 16, 2019. THE EVENT DESCRIPTION STATES: "WHEN REMOVING A TERUMO SURFLO IV CATHETER UPON IV DISCONTINUANCE, THE CATHETER BROKE DURING WITHDRAWAL AND THE TIP WAS RETAINED INSIDE THE VEIN. THE PT HAD TO HAVE EMERGENCY SURGERY TO REMOVE THE CATHETER TO
Patient problems: Blood Loss; No Consequences Or Impact To Patient
MAUDE report 8641600 ↗
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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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