SURFLO SR-OX2032CARecalls & reported problems
Terumo (Philippines) Corporation · SURFLO IV Catheter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 34806017512256), received between May 7, 2025 and May 7, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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
- Break2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2025Break; Break
THE USER FACILITY REPORTED AN INCIDENT WHERE THE TIP OF A CATHETER BROKE OFF FROM THE HUB INSIDE A PATIENT, AND THE TIP WAS SUBSEQUENTLY REMOVED. ADDITIONAL INFORMATION RECEIVED ON 08 APR 2025: FROM THE NURSE MANAGER INCLUDES THE FOLLOWING DETAILS: ON (B)(6) 2025, THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR A LEFT RADIAL PERCUTANEOUS FIXATION PROCEDURE TO INSERT A PIN ON THE RIGHT SIDE AND APPLY A SPLINT ON THE LEFT SIDE. AN IV WAS ADMINISTERED DURING THE PROCEDURE. ON (B)(6) 2025, THE PRIMARY NURSE REMOVED THE IV AND DISCOVERED THAT THE CATHETER HAD BROKEN OFF INSIDE THE PATIENT'S ARM. THE ENTIRE CATHETER WAS BROKEN INSIDE THE PATIENT'S ARM, EXCEPT FOR LESS THAN 1MM REMAINING ON THE HUB. AN ULTRASOUND REVEALED THE CATHETER IN THE UPPER ARM, 1 CM DEEP. AN EMERGENCY INCISION AND DRAINAGE PROCEDURE WERE PERFORMED TO REMOVE THE CATHETER. THE PATIENT RECEIVED TWO STITCHES, EXPERIENCED MINIMAL BLOOD LOSS, AND REMAINED STABLE BEFORE AND AFTER THE PROCEDURE. THE PATIENT WAS DISCHARGED THE SAME DAY.
Patient problems: Foreign Body In Patient
MAUDE report 21980051 ↗InjuryMay 7, 2025Break; Break
THE USER FACILITY REPORTED AN INCIDENT WHERE THE TIP OF A CATHETER BROKE OFF FROM THE HUB INSIDE A PATIENT, AND THE TIP WAS SUBSEQUENTLY REMOVED. ADDITIONAL INFORMATION RECEIVED ON 08 APR 2025: FROM THE NURSE MANAGER INCLUDES THE FOLLOWING DETAILS: ON (B)(6) 2025, THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR A LEFT RADIAL PERCUTANEOUS FIXATION PROCEDURE TO INSERT A PIN ON THE RIGHT SIDE AND APPLY A SPLINT ON THE LEFT SIDE. AN IV WAS ADMINISTERED DURING THE PROCEDURE. ON (B)(6) 2025, THE PRIMARY NURSE REMOVED THE IV AND DISCOVERED THAT THE CATHETER HAD BROKEN OFF INSIDE THE PATIENT'S ARM. THE ENTIRE CATHETER WAS BROKEN INSIDE THE PATIENT'S ARM, EXCEPT FOR LESS THAN 1MM REMAINING ON THE HUB. AN ULTRASOUND REVEALED THE CATHETER IN THE UPPER ARM, 1 CM DEEP. AN EMERGENCY INCISION AND DRAINAGE PROCEDURE WERE PERFORMED TO REMOVE THE CATHETER. THE PATIENT RECEIVED TWO STITCHES, EXPERIENCED MINIMAL BLOOD LOSS, AND REMAINED STABLE BEFORE AND AFTER THE PROCEDURE. THE PATIENT WAS DISCHARGED THE SAME DAY.
Patient problems: Foreign Body In Patient
MAUDE report 21980043 ↗
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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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