SURFLASH SR*FF2032Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 34987350743573), received between Sep 1, 2022 and Sep 8, 2022 — classified as 1 injury, 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.
Most reported problems
Device problems
- Break1
- Material Separation1
- Obstruction of Flow1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2022Break; Obstruction of Flow; Break; Obstruction of Flow
THE USER FACILITY REPORTED THAT THE TERUMO SURFLASH I.V. CATHETER DEVICE WAS BROKEN AT THE CATHETER AND DID NOT ALLOW BLOOD RETURN. THERE WAS NO PATIENT INJURY OR MEDICAL/SURGICAL INTERVENTION REQUIRED. NO HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15378893 ↗InjurySep 1, 2022Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking
THE USER FACILITY REPORTED THAT THE TERUMO SURFLASH I.V. CATHETER INVOLVED DISENGAGED FROM ITS HUB WHILE IN THE PATIENT'S VEIN. THE PATIENT HAD EXERTED TRACTION ON THE CATHETER. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. NO HARM WAS REPORTED. THE EVENT OCCURRED INTRA-OPERATIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15334548 ↗
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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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