SURFLASHRecalls & reported problems across all models

We found 5 models of SURFLASH by Terumo Corporation in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Mar 8, 2018 and Oct 27, 2025 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Material Separation” (15 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SURFLASH problems

SURFLASH models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SURFLASH SR*FF2225

  Catheter,intravascular,therapeutic,short-term less than 30 days
  15 reports
• SURFLASH SR*FF2419

  Catheter,intravascular,therapeutic,short-term less than 30 days
  4 reports
• SURFLASH SR*FF2032

  Catheter,intravascular,therapeutic,short-term less than 30 days
  2 reports
• SURFLASH SR*FF1832

  Catheter,intravascular,therapeutic,short-term less than 30 days
  2 reports
• SURFLASH SR*FF2025

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report

Recent SURFLASH adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED ON 10DEC2025: THE PERSON WHO REMOVED THE TAPE WHEN REMOVING THE CATHETER WAS MEDIAL TO THE INSERTION POINT AND CUT THE TAPE IN A VERTICAL FASHION.

  Patient problems: Foreign Body In Patient

  MAUDE report 23391738 ↗
• MalfunctionJul 18, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED CATHETER SPLIT INTERNALLY UPON PLACEMENT WITH THE MOST RECENT SET OF 22G X 1" TERUMO SURFLASH WINGLESS CATHETERS. NO SURGICAL INTERVENTION WAS REQUIRED. NO BLOOD LOSS WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER TYPE OF DEVICE. THE PATIENT IMPACT WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 27JUN2025: THE CATHETER WOULD NOT ADVANCE AS IT HAD SPLIT. IT WAS REMOVED FROM THE PATIENT WITH NO LONG-TERM IMPACT OR INTERVENTION REQUIRED. THERE WAS NO BLOOD LOSS. THE USER WAS ABLE TO SUCCESSFULLY PLACE A TERUMO SURFLO-W 22G WINGED CATHETER SUCCESSFULLY IN THE PATIENT WITH NO ISSUE. THE PRODUCTS WERE USED ON DOGS AND CATS. THE AFFECTED SAMPLES HAVE BEEN DISCARDED, AND NO PHOTOS WERE TAKEN AS IT WAS DURING THE PLACEMENT IN ANESTHETIZED PATIENTS; THEREFORE, THEY WERE DISCARDED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541787 ↗
• MalfunctionJul 18, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED CATHETER SPLIT INTERNALLY UPON PLACEMENT WITH THE MOST RECENT SET OF 22G X 1" TERUMO SURFLASH WINGLESS CATHETERS. NO SURGICAL INTERVENTION WAS REQUIRED. NO BLOOD LOSS WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER TYPE OF DEVICE. THE PATIENT IMPACT WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 27JUN2025: THE CATHETER WOULD NOT ADVANCE AS IT HAD SPLIT. IT WAS REMOVED FROM THE PATIENT WITH NO LONG-TERM IMPACT OR INTERVENTION REQUIRED. THERE WAS NO BLOOD LOSS. THE USER WAS ABLE TO SUCCESSFULLY PLACE A TERUMO SURFLO-W 22G WINGED CATHETER SUCCESSFULLY IN THE PATIENT WITH NO ISSUE. THE PRODUCTS WERE USED ON DOGS AND CATS. THE AFFECTED SAMPLES HAVE BEEN DISCARDED, AND NO PHOTOS WERE TAKEN AS IT WAS DURING THE PLACEMENT IN ANESTHETIZED PATIENTS; THEREFORE, THEY WERE DISCARDED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541775 ↗
• MalfunctionJul 18, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED CATHETER SPLIT INTERNALLY UPON PLACEMENT WITH THE MOST RECENT SET OF 22G X 1" TERUMO SURFLASH WINGLESS CATHETERS. NO SURGICAL INTERVENTION WAS REQUIRED. NO BLOOD LOSS WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER TYPE OF DEVICE. THE PATIENT IMPACT WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 27JUN2025: THE CATHETER WOULD NOT ADVANCE AS IT HAD SPLIT. IT WAS REMOVED FROM THE PATIENT WITH NO LONG-TERM IMPACT OR INTERVENTION REQUIRED. THERE WAS NO BLOOD LOSS. THE USER WAS ABLE TO SUCCESSFULLY PLACE A TERUMO SURFLO-W 22G WINGED CATHETER SUCCESSFULLY IN THE PATIENT WITH NO ISSUE. THE PRODUCTS WERE USED ON DOGS AND CATS. THE AFFECTED SAMPLES HAVE BEEN DISCARDED, AND NO PHOTOS WERE TAKEN AS IT WAS DURING THE PLACEMENT IN ANESTHETIZED PATIENTS; THEREFORE, THEY WERE DISCARDED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541708 ↗
• MalfunctionJul 18, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED CATHETER SPLIT INTERNALLY UPON PLACEMENT WITH THE MOST RECENT SET OF 22G X 1" TERUMO SURFLASH WINGLESS CATHETERS. NO SURGICAL INTERVENTION WAS REQUIRED. NO BLOOD LOSS WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER TYPE OF DEVICE. THE PATIENT IMPACT WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 27JUN2025: THE CATHETER WOULD NOT ADVANCE AS IT HAD SPLIT. IT WAS REMOVED FROM THE PATIENT WITH NO LONG-TERM IMPACT OR INTERVENTION REQUIRED. THERE WAS NO BLOOD LOSS. THE USER WAS ABLE TO SUCCESSFULLY PLACE A TERUMO SURFLO-W 22G WINGED CATHETER SUCCESSFULLY IN THE PATIENT WITH NO ISSUE. THE PRODUCTS WERE USED ON DOGS AND CATS. THE AFFECTED SAMPLES HAVE BEEN DISCARDED, AND NO PHOTOS WERE TAKEN AS IT WAS DURING THE PLACEMENT IN ANESTHETIZED PATIENTS; THEREFORE, THEY WERE DISCARDED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541703 ↗
• MalfunctionJul 18, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED CATHETER SPLIT INTERNALLY UPON PLACEMENT WITH THE MOST RECENT SET OF 22G X 1" TERUMO SURFLASH WINGLESS CATHETERS. NO SURGICAL INTERVENTION WAS REQUIRED. NO BLOOD LOSS WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER TYPE OF DEVICE. THE PATIENT IMPACT WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 27JUN2025: THE CATHETER WOULD NOT ADVANCE AS IT HAD SPLIT. IT WAS REMOVED FROM THE PATIENT WITH NO LONG-TERM IMPACT OR INTERVENTION REQUIRED. THERE WAS NO BLOOD LOSS. THE USER WAS ABLE TO SUCCESSFULLY PLACE A TERUMO SURFLO-W 22G WINGED CATHETER SUCCESSFULLY IN THE PATIENT WITH NO ISSUE. THE PRODUCTS WERE USED ON DOGS AND CATS. THE AFFECTED SAMPLES HAVE BEEN DISCARDED, AND NO PHOTOS WERE TAKEN AS IT WAS DURING THE PLACEMENT IN ANESTHETIZED PATIENTS; THEREFORE, THEY WERE DISCARDED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541481 ↗
• MalfunctionJul 18, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED CATHETER SPLIT INTERNALLY UPON PLACEMENT WITH THE MOST RECENT SET OF 22G X 1" TERUMO SURFLASH WINGLESS CATHETERS. NO SURGICAL INTERVENTION WAS REQUIRED. NO BLOOD LOSS WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER TYPE OF DEVICE. THE PATIENT IMPACT WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 27JUN2025: THE CATHETER WOULD NOT ADVANCE AS IT HAD SPLIT. IT WAS REMOVED FROM THE PATIENT WITH NO LONG-TERM IMPACT OR INTERVENTION REQUIRED. THERE WAS NO BLOOD LOSS. THE USER WAS ABLE TO SUCCESSFULLY PLACE A TERUMO SURFLO-W 22G WINGED CATHETER SUCCESSFULLY IN THE PATIENT WITH NO ISSUE. THE PRODUCTS WERE USED ON DOGS AND CATS. THE AFFECTED SAMPLES HAVE BEEN DISCARDED, AND NO PHOTOS WERE TAKEN AS IT WAS DURING THE PLACEMENT IN ANESTHETIZED PATIENTS; THEREFORE, THEY WERE DISCARDED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541307 ↗
• MalfunctionJul 18, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED CATHETER SPLIT INTERNALLY UPON PLACEMENT WITH THE MOST RECENT SET OF 22G X 1" TERUMO SURFLASH WINGLESS CATHETERS. NO SURGICAL INTERVENTION WAS REQUIRED. NO BLOOD LOSS WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER TYPE OF DEVICE. THE PATIENT IMPACT WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 27JUN2025: THE CATHETER WOULD NOT ADVANCE AS IT HAD SPLIT. IT WAS REMOVED FROM THE PATIENT WITH NO LONG-TERM IMPACT OR INTERVENTION REQUIRED. THERE WAS NO BLOOD LOSS. THE USER WAS ABLE TO SUCCESSFULLY PLACE A TERUMO SURFLO-W 22G WINGED CATHETER SUCCESSFULLY IN THE PATIENT WITH NO ISSUE. THE PRODUCTS WERE USED ON DOGS AND CATS. THE AFFECTED SAMPLES HAVE BEEN DISCARDED, AND NO PHOTOS WERE TAKEN AS IT WAS DURING THE PLACEMENT IN ANESTHETIZED PATIENTS; THEREFORE, THEY WERE DISCARDED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541305 ↗
• MalfunctionJul 18, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED CATHETER SPLIT INTERNALLY UPON PLACEMENT WITH THE MOST RECENT SET OF 22G X 1" TERUMO SURFLASH WINGLESS CATHETERS. NO SURGICAL INTERVENTION WAS REQUIRED. NO BLOOD LOSS WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER TYPE OF DEVICE. THE PATIENT IMPACT WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 27JUN2025: THE CATHETER WOULD NOT ADVANCE AS IT HAD SPLIT. IT WAS REMOVED FROM THE PATIENT WITH NO LONG-TERM IMPACT OR INTERVENTION REQUIRED. THERE WAS NO BLOOD LOSS. THE USER WAS ABLE TO SUCCESSFULLY PLACE A TERUMO SURFLO-W 22G WINGED CATHETER SUCCESSFULLY IN THE PATIENT WITH NO ISSUE. THE PRODUCTS WERE USED ON DOGS AND CATS. THE AFFECTED SAMPLES HAVE BEEN DISCARDED, AND NO PHOTOS WERE TAKEN AS IT WAS DURING THE PLACEMENT IN ANESTHETIZED PATIENTS; THEREFORE, THEY WERE DISCARDED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541304 ↗
• MalfunctionJul 18, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED CATHETER SPLIT INTERNALLY UPON PLACEMENT WITH THE MOST RECENT SET OF 22G X 1" TERUMO SURFLASH WINGLESS CATHETERS. NO SURGICAL INTERVENTION WAS REQUIRED. NO BLOOD LOSS WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER TYPE OF DEVICE. THE PATIENT IMPACT WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 27JUN2025: THE CATHETER WOULD NOT ADVANCE AS IT HAD SPLIT. IT WAS REMOVED FROM THE PATIENT WITH NO LONG-TERM IMPACT OR INTERVENTION REQUIRED. THERE WAS NO BLOOD LOSS. THE USER WAS ABLE TO SUCCESSFULLY PLACE A TERUMO SURFLO-W 22G WINGED CATHETER SUCCESSFULLY IN THE PATIENT WITH NO ISSUE. THE PRODUCTS WERE USED ON DOGS AND CATS. THE AFFECTED SAMPLES HAVE BEEN DISCARDED, AND NO PHOTOS WERE TAKEN AS IT WAS DURING THE PLACEMENT IN ANESTHETIZED PATIENTS; THEREFORE, THEY WERE DISCARDED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541302 ↗
• MalfunctionJul 3, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED CATHETER SPLIT INTERNALLY UPON PLACEMENT WITH THE MOST RECENT SET OF 22G X 1" TERUMO SURFLASH WINGLESS CATHETERS. NO SURGICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER TYPE OF DEVICE. THE PATIENT IMPACT WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 27JUN2025: THE CATHETER WOULD NOT ADVANCE AS IT HAD SPLIT. IT WAS REMOVED FROM THE PATIENT WITH NO LONG-TERM IMPACT OR INTERVENTION REQUIRED. THERE WAS NO BLOOD LOSS. THE USER WAS ABLE TO SUCCESSFULLY PLACE A TERUMO SURFLO-W 22G WINGED CATHETER SUCCESSFULLY IN THE PATIENT WITH NO ISSUE. THE PRODUCTS WERE USED ON DOGS AND CATS. THE AFFECTED SAMPLES HAVE BEEN DISCARDED, AND NO PHOTOS WERE TAKEN AS IT WAS DURING THE PLACEMENT IN ANESTHETIZED PATIENTS; THEREFORE, THEY WERE DISCARDED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22393957 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 26, 2023Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED ON 09 MAY 2023: THE ISSUE WAS DISCOVERED DURING REMOVAL OF THE CATHETER; HOWEVER, IT WAS UNCLEAR WHEN THEY OCCURRED. THE CATHETER HAD BEEN IN PLACE IN THE FELINE FOR 24 HOURS PLUS, AND THE DOG ONLY DURING THE DAY AS WAS A DAY PATIENT. THERE WAS NO KNOWN ISSUE WITH THE STYLET WHEN IT WAS IN PLACE. THE CANINE CATHETER BROKE WITHIN THE TUBE. IT APPEARED TO BE APPROXIMATELY 1 /4 -1 /3 OF THE WAY DOWN FROM THE HUB, BY THE PHOTO. IT WAS A SIMILAR THING WITH THE FELINE, UNFORTUNATELY THE CATHETER WAS THEN THROWN AWAY; THEREFORE, IT WAS UNCLEAR EXACTLY WHERE IN THE TUBE THE BREAK OCCURRED. IN BOTH CASES THE HUB/TUBE ATTACHMENTS WERE STILL IN PLACE AND SECURED. THE CATHETER REMAINING IN THE FELINE WAS SIMPLY REMOVED MANUALLY. THE CATHETER REMAINING IN THE CANINE COULD NOT BE PALPATED AND DID NOT SHOW UP RADIOGRAPHICALLY. THE PATIENT WAS REFERRED, AND THE CATHETER WAS LOCATED USING ULTRASOUND AND REMOVED UNDER SEDATION. NO IMPACT ON THE FELINE, BUT ADDITIONAL SEDATION AND FURTHER VENESECTION FOR REMOVAL WERE REQUIRED FOR THE CANINE. THE REMAINING CATHETER WAS SIMPLY REMOVED MANUALLY FROM THE FELINE. FOR THE CANINE, THE CATHETER COULD NOT BE PALPATED AND DI

  Patient problems: Foreign Body In Patient

  MAUDE report 16814839 ↗
• MalfunctionApr 26, 2023Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023: THE ISSUE WAS DISCOVERED DURING REMOVAL OF THE CATHETER; HOWEVER, IT WAS UNCLEAR WHEN THEY OCCURRED. THE CATHETER HAD BEEN IN PLACE IN THE FELINE FOR 24 HOURS PLUS, AND THE DOG ONLY DURING THE DAY AS WAS A DAY PATIENT. THERE WAS NO KNOWN ISSUE WITH THE STYLET WHEN IT WAS IN PLACE. THE CANINE CATHETER BROKE WITHIN THE TUBE. IT APPEARED TO BE APPROXIMATELY 1 /4 -1 /3 OF THE WAY DOWN FROM THE HUB, BY THE PHOTO. IT WAS A SIMILAR THING WITH THE FELINE, UNFORTUNATELY THE CATHETER WAS THEN THROWN AWAY; THEREFORE, IT WAS UNCLEAR EXACTLY WHERE IN THE TUBE THE BREAK OCCURRED. IN BOTH CASES THE HUB/TUBE ATTACHMENTS WERE STILL IN PLACE AND SECURED. THE CATHETER REMAINING IN THE FELINE WAS SIMPLY REMOVED MANUALLY. THE CATHETER REMAINING IN THE CANINE COULD NOT BE PALPATED AND DID NOT SHOW UP RADIOGRAPHICALLY. THE PATIENT WAS REFERRED, AND THE CATHETER WAS LOCATED USING ULTRASOUND AND REMOVED UNDER SEDATION. NO IMPACT ON THE FELINE, BUT ADDITIONAL SEDATION AND FURTHER VENESECTION FOR REMOVAL WERE REQUIRED FOR THE CANINE. THE REMAINING CATHETER WAS SIMPLY REMOVED MANUALLY FROM THE FELINE. FOR THE CANINE, THE CATHETER COULD NOT BE PALPATED AND D

  Patient problems: Foreign Body In Patient

  MAUDE report 16814838 ↗

Other Terumo Corporation products

• CAPIOXFX12 models · 328 reports
• GLIDEWIRE30 models · 194 reports
• RUNTHROUGH7 models · 170 reports
• CAPIOXRX9 models · 162 reports
• GLIDEWIRE ADVANTAGE5 models · 79 reports
• GLIDECATH9 models · 57 reports
• R2P MISAGO13 models · 54 reports
• NAVICROSS11 models · 49 reports