SURFLO SR-OX1451CARecalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 34806017510146), received between Nov 9, 2024 and Nov 9, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component2
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.
MalfunctionNov 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THE 14-GAUGE SURFLO CATHETER WAS PLACED BY A CRNA PRIOR TO CARDIAC SURGERY. ON POST-OPERATIVE DAY 5, WHILE ATTEMPTING TO REMOVE THE CATHETER, THE PCU RN NOTICED THAT THE HUB HAD DETACHED, LEAVING THE CATHETER RETAINED IN THE PATIENT'S VEIN. CONSEQUENTLY, THE PATIENT REQUIRED A MINOR SURGICAL PROCEDURE BY THE ORTHO - HAND SURGICAL SERVICE TO REMOVE THE RETAINED CATHETER ON (B)(6) 2024. THE SURGEON HANDED THE RETAINED CATHETER TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 16 OCT 2024: THERE WAS NO DOCUMENTED DIFFICULTY INTRODUCING THE CATHETER WHEN IT WAS PLACED ON (B)(6) 2024, NOR WAS THERE ANY DOCUMENTATION OF FLUID LEAKAGE DURING THE FIVE DAYS IT WAS IN PLACE. THE DRUG BEING DELIVERED THROUGH THE CATHETER IS UNKNOWN. THE CATHETER WAS SECURED WITH 3M TEGADERM IV 1633 DURING THIS TIME. THE METHOD USED TO REMOVE THE SECURE DRESSING IS BY HAND. IT APPEARS THAT THE WHITE CATHETER PORTION SIMPLY DISCONNECTED FROM THE HUB. THE CATHETER DID NOT TRAVEL FAR WITHIN THE ANATOMY AND REMAINED IN THE RADIAL ASPECT OF THE DISTAL RIGHT FOREARM. EXTENT OF THE MINOR SURGICAL PROCEDURE: THE PROCEDURE REPORT STATES THAT A PALPABLE THIN OBJECT APPROXIMATELY 5 CM
Patient problems: Foreign Body In Patient
MAUDE report 20646846 ↗InjuryNov 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THE 14-GAUGE SURFLO CATHETER WAS PLACED BY A CRNA PRIOR TO CARDIAC SURGERY. ON POST-OPERATIVE DAY 5, WHILE ATTEMPTING TO REMOVE THE CATHETER, THE PCU RN NOTICED THAT THE HUB HAD DETACHED, LEAVING THE CATHETER RETAINED IN THE PATIENT'S VEIN. CONSEQUENTLY, THE PATIENT REQUIRED A MINOR SURGICAL PROCEDURE BY THE ORTHO - HAND SURGICAL SERVICE TO REMOVE THE RETAINED CATHETER ON (B)(6) 2024. THE SURGEON HANDED THE RETAINED CATHETER TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 16 OCT 2024: THERE WAS NO DOCUMENTED DIFFICULTY INTRODUCING THE CATHETER WHEN IT WAS PLACED ON (B)(6) 2024, NOR WAS THERE ANY DOCUMENTATION OF FLUID LEAKAGE DURING THE FIVE DAYS IT WAS IN PLACE. THE DRUG BEING DELIVERED THROUGH THE CATHETER IS UNKNOWN. THE CATHETER WAS SECURED WITH 3M TEGADERM IV 1633 DURING THIS TIME. THE METHOD USED TO REMOVE THE SECURE DRESSING IS BY HAND. IT APPEARS THAT THE WHITE CATHETER PORTION SIMPLY DISCONNECTED FROM THE HUB. THE CATHETER DID NOT TRAVEL FAR WITHIN THE ANATOMY AND REMAINED IN THE RADIAL ASPECT OF THE DISTAL RIGHT FOREARM. EXTENT OF THE MINOR SURGICAL PROCEDURE: THE PROCEDURE REPORT STATES THAT A PALPABLE THIN OBJECT APPROXIMATELY 5 CM
Patient problems: Foreign Body In Patient
MAUDE report 20646786 ↗
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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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