SURFLO SR-OX1832CARecalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 34806017512232), received between May 22, 2025 and May 22, 2025 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2025Break; Break
TERUMO MEDICAL RECEIVED AN FDA UF REPORT MW#(B)(4). THE EVENT DESCRIPTION STATES THAT ON (B)(6) 2025; A PERIPHERAL IV 18 G CATHETER WAS INSERTED IN THE RIGHT UPPER EXTREMITY WITH ULTRASOUND GUIDANCE IN THE OPERATING ROOM (OR) VIA ROUTINE STRAIGHTFORWARD INSERTION IN ONE ATTEMPT BY AN EXPERIENCED ANESTHESIOLOGIST. THE PATIENT UNDERWENT REVISION RIGHT TOTAL KNEE REPLACEMENT AND PROGRESSED WITH RECOVERY. THERE WERE NO ISSUES WITH THE PERIPHERAL IV CATHETER POST-OPERATIVELY. WHEN IT WAS REMOVED ON (B)(6) 2025, BY A REGISTERED NURSE (RN) AS THE PATIENT WAS PREPARING FOR DISCHARGE FROM THE HOSPITAL, IT WAS DISCOVERED BROKEN. THE REMOVAL OF THE CATHETER WAS ROUTINE, WITH NOTHING UNUSUAL UNTIL THE CATHETER WAS NOTED AS BROKEN. THE DISCHARGE TO A REHAB FACILITY WAS CANCELED. A RIGHT ELBOW X-RAY AND CT SCAN CONFIRMED A RETAINED CATHETER FRAGMENT. THE PATIENT WAS RETURNED TO THE OR ON (B)(6) 2025, FOR REMOVAL OF RIGHT ELBOW FOREIGN BODY BY A HAND & WRIST SURGEON UNDER MONITORED ANESTHESIA CARE (MAC). THE RETAINED CATHETER FRAGMENT WAS REMOVED IN ONE PIECE VIA A 0.5 CM LONGITUDINAL INCISION MADE DIRECTLY OVER THE DISTAL TIP OF THE CATHETER. THERE WERE NO COMPLICATIONS FROM THE PROCEDURE. GROSS
Patient problems: Foreign Body In Patient
MAUDE report 22072800 ↗
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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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