SURFLASH SR*FF2225Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 34987350743597), received between Aug 8, 2022 and Oct 27, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Separation” (14 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.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, 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 ↗
• 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 ↗
• MalfunctionOct 20, 2022Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT WHEN A TERUMO SURFLASH I.V. CANNULA 22GXL" WAS USED TO PLACE AN INTRAVENOUS (IV) LINE, A PART OF THE PLASTIC CATHETER TIP SNAPPED AWAY AND REMAINED IN THE PATIENT'S CEPHALIC VEIN. THIS REQUIRED A MINOR PROCEDURE TO REMOVE THE PART LEFT. THE PLANNED PROCEDURE STILL WENT AHEAD ALBEIT IT WAS A SLIGHTLY LONGER ANESTHETIC THAN PLANNED. THE PATIENT WAS FINE. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022: THE PATIENT WAS IN FOR AN OVARIO-HYSTERECTOMY. THE PATIENT HAD BEEN PRE-MEDICATED, AND THE IV CATHETER WAS PLACED TO INDUCE ANESTHETIC. THE CATHETER WAS PLACED IN WAS THE RIGHT CEPHALIC VEIN. THE HEAD VET THEN USED A CEPHALIC CUT DOWN PROCEDURE TO EXPOSE THE VEIN, LOCATE THE FRAGMENT OF CATHETER, REMOVE, AND THEN SUTURE THE WOUND. AN IV LINE WAS PLACED IN THE LEFT CEPHALIC INSTEAD WITH NO ISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 15644653 ↗
• MalfunctionAug 8, 2022Break; Break

  THE USER FACILITY REPORTED THAT AFTER TREATMENT AND UPON REMOVAL, THE INVOLVED SURFLASH POLY CATHETER BROKE OFF. THE DOCTOR WAS ABLE TO MILK THE DEVICE OUT. MEDS WERE ADMINISTERED DURING TREATMENT, SO IT DID WORK DURING THE PROCEDURE. THERE WAS NO INCISION NEEDED TO REMOVE THE DEVICE. THE ANIMAL WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. NO EQUIPMENT OR OTHER DEVICES WERE USED WITH THE INVOLVED DEVICE. THE EVENT OCCURRED POST-TREATMENT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022: THE PATIENT WAS A FELINE. THE CATHETER WAS PLACED IN THE FRONT RIGHT ARM. ALMOST THE FULL LENGTH OF THE CATHETER BROKE OFF, THERE WAS ONLY A FEW MM FROM THE CONNECTION TO THE PORT. MOST OF THE CATHETER BROKE OFF INTO THE PATIENTS ARM WHEN IT WAS PULLED OUT. THERE WAS NO DEATH. THE DOCTOR WAS ABLE TO SLOWLY MILK/PUSH OUT THE CATHETER. THERE WAS NO BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15182047 ↗