SURFLASH SR*FF2419Recalls & reported problems
Terumo Corporation · SURFLASH I.V. catheter · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 34987350743535), received between Mar 8, 2018 and Feb 20, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Puncture/Hole2
- Break1
- Material Deformation1
Patient problems
- Insufficient Information2
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2024Material Deformation; Material Deformation
THE USER FACILITY REPORTED THAT THE CATHETER INVOLVED HAD DAMAGE. DURING USE OF THE CATHETER, THE NEEDLE PIERCED THE CATHETER AS IT WAS REPOSITIONED TO THE CORRECT AXIS. THE EVENT OCCURRED INTRA-OPERATIVE. NO HARM WAS REPORTED. THERE WAS NO MEDICAL INTERVENTION FOLLOWING THE ACCIDENT. THE PROCEDURE OUTCOME WAS UNKNOWN. THE FINAL PATIENT IMPACT WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18737377 ↗MalfunctionOct 13, 2022Material Puncture/Hole; Material Puncture/Hole
THE USER FACILITY REPORTED THAT A NEEDLE HAD PUNCTURED THE CATHETER INVOLVED. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO HARM REPORTED AND NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS UNKNOWN. THE FINAL PATIENT IMPACT WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 15594100 ↗MalfunctionOct 13, 2022Material Puncture/Hole; Material Puncture/Hole
THE USER FACILITY REPORTED THAT A NEEDLE HAD PUNCTURED THE CATHETER INVOLVED. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO HARM REPORTED AND NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS UNKNOWN. THE FINAL PATIENT IMPACT WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 15594091 ↗MalfunctionMar 8, 2018Break; Break
THE USER FACILITY REPORTED A CATHETER WAS PLACED YESTERDAY MORNING AND REMOVED THIS EVENING, PART OF THE INNER SHEATH WAS LEFT INSIDE. SURGICALLY REMOVED FROM THE CAT. ADDITIONAL INFORMATION WAS RECEIVED ON 2/16/18: SURGICAL INTERVENTION DID NOT TAKE PLACE, AS INITIALLY REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 2/20/18: IT WAS REPORTED THAT THE CATHETER WAS PLACED ON (B)(6) 2018 IN RIGHT CEPHALIC IN FELINE MALE CAT. THE FELINE WAS BEING TREATED FOR RENAL FAILURE. CATHETER WAS PLACED FOR APPROXIMATELY 24 HOURS, WITH NO LEAKAGE NOTED DURING PLACEMENT, AND NO KNOWN DIFFICULTY DURING VEIN ENTRY. UPON REMOVAL OF CATHETER, AT CONCLUSION OF TREATMENT, IT WAS NOTED APPROXIMATELY 1/2 OF CATHETER WAS MISSING. THE FACILITY WAS NOT ABLE TO FIND THE CATHETER IN VEIN, AND PERFORMED X-RAYS. THEY WERE STILL NOT ABLE TO LOCATE THE CATHETER, HOWEVER THEY RELEASED THE FELINE TO OWNER'S CARE, WITH FELINE FAILING HEALTH DUE TO RENAL FAILURE. FELINE DID NOT SHOW ANY ILL EFFECTS OF CATHETER MIGRATION.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7324552 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.