SURFLO SR-OX2051CARecalls & reported problems
Terumo (Philippines) Corporation · SURFLO IV Catheter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 34806017512249), received between Jan 30, 2025 and Oct 15, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (3 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
- Break3
Patient problems
- Foreign Body In Patient3
- Thrombosis/Thrombus2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 15, 2025Break; Break
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: A PATIENT UNDERWENT REVISION OF AN INFECTED LEFT TOTAL KNEE REPLACEMENT ON (B)(6) 2025. ON (B)(6) 2025, A 20-GAUGE PERIPHERAL INTRAVENOUS (IV) CATHETER WAS PLACED ANTERIORLY IN THE LEFT FOREARM BY AN ANESTHESIOLOGIST. PLACEMENT WAS ROUTINE VIA THE FIRST INSERTION ATTEMPT. DAILY ASSESSMENTS WERE PERFORMED 3 - 4 TIMES PER DAY, WITH TWICE-DAILY FLUSHING AND CAPPING. FLUIDS WERE DELIVERED SUCCESSFULLY FROM THE TIME OF PLACEMENT WITH NO ISSUES NOTED UNTIL (B)(6) 2025 AT 14:51, WHEN THE IV WAS FOUND TO BE LEAKING DURING A DRESSING CHANGE PERFORMED BY A REGISTERED NURSE (RN). THE RN OBSERVED THAT THE CATHETER TIP WAS MISSING FROM THE MAIN CATHETER TUBING, WITH APPROXIMATELY 1 MM REMAINING. NO BLOOD LOSS WAS REPORTED. MEDWATCH RECEIVED BY CUSTOMER CARE ON (B)(6) 2025. MEDWATCH NUMBER (B)(4). "REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. PORTABLE LEFT FOREARM X-RAY ON (B)(6) 2025 IMPRESSION WAS, 4.7 CM PIECE OF TUBING IN THE SUBCUTANEOUS TISSUE OF THE VOLAR ASPECT OF THE PROXIMAL FOREARM, THE MOST PROXIMAL PORTION OF WHICH IS AT THE LEVEL OF THE RADIAL TUBEROSITY. ULTRASOUND IMPRESSION ON (B)(6) 2025 WAS ULTRASO
Patient problems: Foreign Body In Patient; Thrombosis/Thrombus
MAUDE report 23306994 ↗InjuryOct 15, 2025Break; Break
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: A PATIENT UNDERWENT REVISION OF AN INFECTED LEFT TOTAL KNEE REPLACEMENT ON (B)(6) 2025. ON (B)(6) 2025, A 20-GAUGE PERIPHERAL INTRAVENOUS (IV) CATHETER WAS PLACED ANTERIORLY IN THE LEFT FOREARM BY AN ANESTHESIOLOGIST. PLACEMENT WAS ROUTINE VIA THE FIRST INSERTION ATTEMPT. DAILY ASSESSMENTS WERE PERFORMED 3 - 4 TIMES PER DAY, WITH TWICE-DAILY FLUSHING AND CAPPING. FLUIDS WERE DELIVERED SUCCESSFULLY FROM THE TIME OF PLACEMENT WITH NO ISSUES NOTED UNTIL (B)(6) 2025 AT 14:51, WHEN THE IV WAS FOUND TO BE LEAKING DURING A DRESSING CHANGE PERFORMED BY A REGISTERED NURSE (RN). THE RN OBSERVED THAT THE CATHETER TIP WAS MISSING FROM THE MAIN CATHETER TUBING, WITH APPROXIMATELY 1 MM REMAINING. NO BLOOD LOSS WAS REPORTED. MEDWATCH RECEIVED BY CUSTOMER CARE ON (B)(6) 2025. MEDWATCH NUMBER (B)(4). "REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. PORTABLE LEFT FOREARM X-RAY ON (B)(6) 2025 IMPRESSION WAS, 4.7 CM PIECE OF TUBING IN THE SUBCUTANEOUS TISSUE OF THE VOLAR ASPECT OF THE PROXIMAL FOREARM, THE MOST PROXIMAL PORTION OF WHICH IS AT THE LEVEL OF THE RADIAL TUBEROSITY. ULTRASOUND IMPRESSION ON (B)(6) 2025 WAS ULTRASO
Patient problems: Foreign Body In Patient; Thrombosis/Thrombus
MAUDE report 23306993 ↗MalfunctionJan 30, 2025Break; Break
THE USER FACILITY REPORTED THAT THE IVC BROKE INTO THE VEIN EITHER AFTER INSERTION OR DURING WITHDRAWAL DURING TREATMENT. THE IVC BROKE AT THE JOINT BETWEEN THE BODY OF THE CANNULA AND THE TUBE RETAINED IN THE PATIENT. THE EVENT OCCURRED INTRA-OPERATIVELY. MEDICAL INTERVENTION WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE FINAL PATIENT IMPACT WAS NO SERIOUS INJURIES.
Patient problems: Foreign Body In Patient
MAUDE report 21280536 ↗
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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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