SURFLASH SR*FF1832Recalls & reported problems
Terumo Corporation · SURFLASH I.V. catheter · Class 2
All models of SURFLASH (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 34987350747519), received between Oct 13, 2022 and Jun 29, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (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
- Difficult to Insert1
- Material Deformation1
- Physical Resistance/Sticking1
Patient problems
- Vasculitis2
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2023Difficult to Insert; Difficult to Insert
THE USER FACILITY REPORTED THAT THE HEAD NURSE WAS CHANNELING THE PATIENT WITH A SURFLASH INTRAVENOUS CATHETER (18G). THERE WERE NO PROBLEMS INSERTING THE INVOLVED DEVICE INTO THE SKIN AND RETURNED, BUT WHEN THE NEEDLE WAS REMOVED TO BEGIN INSERTING THE CATHETER DID NOT SLIP AND THE PATIENT BEGAN TO REPORT PAIN. THE ATTEMPTS WERE UNSUCCESSFUL AND TO STOP THE PATIENT FOR BEING HURT, THE CATHETER WAS REMOVED. ANOTHER LINE WAS CHANNELED WITH ANOTHER SURFLASH (20G GAUGE) WHICH WAS THE ONLY ONE ON HAND, THIS SECOND CHANNELING WAS SUCCESSFUL. ANOTHER VEIN HAD TO BE CHANNELED WITH ANOTHER RECHANNELED SURFLASH. THE PATIENT IS EPILEPTIC. THE EVENT OCCURRED INTRA- OPERATIVE. THE PATIENT GOT PHLEBITIS IN THE PUNCTURED AREA. NO TREATMENT FOR PHLEBITIS WAS PERFORMED, IT WAS ONLY RECANALIZED TO ANOTHER SITE. A NEW CATHETER WAS USED TO RECANALIZATION. ANOTHER PUNCTURE WAS PERFORMED ON OTHER SITE. THE FINAL PATIENT IMPACT WAS STABLE.
Patient problems: Pain; Vasculitis
MAUDE report 17232711 ↗MalfunctionOct 13, 2022Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking
THE USER FACILITY REPORTED THAT AFTER PUNCTURE WITH THE CATHETER INVOLVED, THE CATHETER WAS INSERTED IN THE PATIENT'S ARM AND RESISTANCE WAS GENERATED. PHLEBITIS OCCURRED IN THE AREA AND THE CATHETER WAS REMOVED. THE NURSE EXAMINED THE AFFECTED DEVICE AND OBSERVED A DAMAGE IN THE DISTAL PART OF THE CATHETER. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT DEVELOPED PHLEBITIS IN THE PUNCTURED AREA. A NEW CATHETER WAS USED, AND THE PUNCTURE PROCEDURE WAS PERFORMED IN THE OTHER ARM. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Vasculitis
MAUDE report 15594111 ↗
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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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