ARROW IPN001348Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10801902127171), received between Nov 11, 2022 and Dec 11, 2025 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K141051); they may or may not involve this specific model.

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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "I FOUND LEAKING BETWEEN THE METAL CANNULAS AND THE JUNCTURE HUB, THE PRODUCT WAS LEAKING AIR WHILE THEY WERE CHECKING FOR BLOOD ASPIRATION, THEY HAVE RECUT THE CATHETER AND TRIED TO FIX THE ISSUE BUT STILL THE AIR LEAKAGE IS PRESENT SO THEY REMOVE THE CATHETER AND USE NEW CATHETER FOR THE CASE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776314 ↗
• MalfunctionNov 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: "VASCULAR SURGEON INSERTED THE CATHETER INTO PATIENT ON COMPLETION OF PROCEDURE, FLUSHING THE PIGTAILS AT THE HUB HE REALIZES THE CATHETER/HUB ASSEMBLY IS LEAKING. CATHETER WAS REMOVED. HE INSERTED ANOTHER CATHETER WHICH WORKED PERFECTLY WELL."

  Patient problems: Insufficient Information

  MAUDE report 23595850 ↗
• InjuryNov 5, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: " CONNECTED THE CATHETER TO START THE HEMODIALYSIS TREATMENT, THE NURSE NOTICED AIR BUBBLES IN THE ARTERIAL LINE AND DETECTED A DEFECT IN AIR ASPIRATION FROM THE EXTERNAL CONNECTION OF THE CATHETER. THE PROCEDURE WAS DELAYED AND THE CATHETER WAS SURGICALLY REMOVED." THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475088 ↗
• MalfunctionJul 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "THE CATHETER WAS INSERTED WITHOUT PROBLEM. AFTER THAT, HOWEVER, WATER LEAKED AND BLOOD COULD NOT BE REMOVED. THEREFORE, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE. NO INJURY TO THE PATIENT OCCURRED. IT IS UNKNOWN AT PRESENT FROM WHICH PART OF THE CATHETER THE LEAK OCCURRED." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22457445 ↗
• MalfunctionJun 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "THE CATHETER WAS INSERTED WITHOUT PROBLEM. AFTER THAT, HOWEVER, WATER LEAKED AND BLOOD COULD NOT BE REMOVED. THEREFORE, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE. NO INJURY TO THE PATIENT OCCURRED. IT IS UNKNOWN AT PRESENT FROM WHICH PART OF THE CATHETER THE LEAK OCCURRED." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144497 ↗
• MalfunctionMay 15, 2025Crack; Crack

  IT WAS REPORTED "(B)(6) 2025, THE DOCTOR FOUND THE LUER HUB HAS CRACK IN THE EXTENSION LINE DURING USE ON THE PATIENT. THE INSERTION DATE IS (B)(6) 2025." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029289 ↗
• MalfunctionMay 7, 2025Material Separation; Material Separation

  IT WAS REPORTED "WHEN THE VASCULAR SURGEON TRIED TO PEEL AWAY THE SMART SEAL SHEATH, IT DID NOT SEPARATE AT THE PROXIMAL OPENING, IT WAS PRIED OPEN, BIT BY BIT AND THEN CUT ALONGSIDE WITH SCISSORS WHILST SLOWLY PUSHING THE CATHETER ALONG." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976875 ↗
• MalfunctionMay 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED "ON (B)(6) 2025, THE EXTENSION LINE WAS FOUND LEAKING DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21975930 ↗
• MalfunctionMay 5, 2025Break; Break

  IT WAS REPORTED "(B)(6) 2025, AFTER HEMODIALYSIS, THE PINCH CLAMP OF ARTERIAL SIDE WAS FOUND BROKEN." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959868 ↗
• MalfunctionApr 16, 2025Crack; Crack

  IT WAS REPORTED "ON (B)(6) 2025, THE DOCTOR FOUND THE LUER HUB HAS A CRACK DURING INSERTION ON THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21846936 ↗
• MalfunctionMar 28, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT "DURING INSERTION, THE DOCTOR FOUND THE CATHETER TIP DEFORM, THE CATHETER TIP CAN'T CONNECT WITH THE PRELOADED TUNNELER DURING USED ON THE PATIENT.". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719281 ↗
• MalfunctionNov 1, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE CATHETER TIP WAS FOUND SPLIT DURING USE ON THE PATIENT. THEY CHANGED A NEW ONE." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20585618 ↗
• MalfunctionOct 10, 2024Crack; Crack

  IT WAS REPORTED "ON (B)(6) 2024, THE LURE HUB/FITTING HAS A CRACK DURING USE ON THE PATIENT. THEY INSERTED THE CATHETER ON (B)(6) 2024. NO HARM FOR THE PATIENT." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20416154 ↗
• MalfunctionSep 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "THE DOCTOR FOUND THE LUER HUB/FITING CONNECTION LEAKED DURING USED ON THE PATIENT. NO HARM FOR THE PATIENT." THE USER CHANGED TO A NEW SET. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212096 ↗
• MalfunctionJul 16, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "AFTER INSERTION OF CATHETER, IT WAS FOUND THAT PROXIMAL LUMEN DID NOT WORK, NO BLOOD FLOW WAS COMING, NO ASPIRATION." THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER VECTROFLOW SUCCESSFULLY. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750659 ↗
• MalfunctionMay 24, 2024Break; Break

  IT WAS REPORTED THAT: "(B)(6) 2024, THE DOCTOR FOUND THE PINCH CLAMP BROKEN DURING USED ON THE PATIENT." THE PATIENT WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390245 ↗
• MalfunctionApr 9, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT: "INCIDENT OCCURRED ON (B)(6) 2024. THE CATHETER WAS IMPOSSIBLE TO ADVANCE, IT CREATED A HAEMATOMA FOR THE PATIENT." ADDITIONAL INFORMATION: THERE WAS NO MEDICAL INTERVENTION OR NEGATIVE CLINICAL CONSEQUENCES FOR THE PATIENT. THEY WERE REPORTED AS STABLE AFTER THE INCIDENT.

  Patient problems: Hematoma

  MAUDE report 19069387 ↗
• MalfunctionOct 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: ACCORDING TO THE DOCTOR THERE WAS A BLOOD LEAKAGE AT THE JUNCTION HUB AFTER THE PATIENT WAS MOVED TO THE WARD, AFTER INSERTION. ADDITIONAL INFORMATION: THE CATHETER WAS REPLACED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860296 ↗
• MalfunctionSep 8, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT: DILATOR FAILED DURING INSERTION OF CVC TO THE RIGHT JUGULAR VEIN. THE PLASTIC PEELED OFF FROM THE TIP. THERE WERE NO CLINICAL CONSEQUENCES OR HARM REPORTED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17709581 ↗
• MalfunctionNov 20, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE COMPLAINT IS REPORTED AS: WE OBSERVED A RIGIDITY MORE IMPORTANT THAN USUAL ON THE "TUBING" OF THE CATHETER WHICH LEADS TO A KINK OF THE CATHETER LINKED TO THE CLAMPS. ON (B)(6) 2022, A PATIENT FACED THIS ISSUE, WITH DIALYSES MACHINE THAT STOPPED SEVERAL TIMES BEACAUSE OF NEGATIVE BLOOD PRESSURE (-300MMHG). THIS AFFECTS THE BLOOD FLOW, THE QUALITY OF DIALYSIS, THE INCREASE IN THE RISK OF COAGULATION, THE PATIENT'S DISCOMFORT AND DELAY IN THE DEPARTMENT.

  Patient problems: Insufficient Information

  MAUDE report 15831585 ↗
• MalfunctionNov 11, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE COMPLAINT IS REPORTED AS: WITH THESE CATHETERS, WE OBSERVED A RIGIDITY MORE IMPORTANT THAN USUAL ON THE "TUBING" OF THE CATHETER WHICH LEADS TO A KINK LINKED TO THE CLAMPS. WHEN THE CLAMP IS OPEN (IN A DIALYSIS SESSION), IT HAPPENS THAT THE PATIENT MOVES AND THAT THIS KINK OBSTRUCTS THE PASSAGE OF BLOOD AND THEREFORE STOPS THE BLOOD PUMP. ADDITIONAL INFORMATION RECEIVED 28OCT2022: THE KINKED IS LINKED TO THE CLAMP WHEN THE CATHETER IS NOT USED. THE TUBING BEING SLIGHTLY RIGID, THE KINK PERSISTS. IF THE PATIENT MOVES SLIGHTLY DURING THE SESSION, THE TUBE PINCHES AT THE KINK. THE CLAMPS ARE MOVED BY THE TEAMS AT EACH SESSION, BUT THIS IS NOT SUFFICIENT TO AVOID THE PROBLEM.

  Patient problems: Insufficient Information

  MAUDE report 15784846 ↗
• MalfunctionNov 11, 2022Obstruction of Flow; Obstruction of Flow

  THE COMPLAINT IS REPORTED AS: CATHETER OBSTRUCTION WAS NOTED ON (B)(6) 2022. A PROTOCOL WITH THERASOLV 100000UI OF 30 MIN WAS DONE. THE PATIENT RETURNED THE NEXT DAY BECAUSE OF LOSS OF CIRCUIT AT THIS SESSION AND INCOMPLETE DIALYSIS. ON THE FOLLOWING SESSION, WE OBSERVED THAT A 3-HOUR THERASOLV PROTOCOL WAS PERFORMED BECAUSE THE CATHETER STILL DID NOT WORK PROPERLY. THE FOLLOWING SESSIONS SHOWED A VERY POOR QUALITY OF DIALYSIS AND THE CAUSE WAS THE CATHETER. (LOW CATHETER/V, LOW BLOOD FLOW). UNTIL MID-AUGUST, WE NOTICED SPECIFIC OBSTRUCTIONS, SOME PROCEDURES WERE ACTIONED TO UNBLOCK THEM. THE LINES WERE REVERSED DURING THE DIALYSIS SESSION, THERE WERE VERY NEGATIVE BLOOD PRESSURES, IT STOPPED THE BLOOD PUMP ON MANY OCCASIONS. ON (B)(6) 2022 THE CATHETER WAS CHANGED. IT WAS IMPOSSIBLE TO DIALYZE THE PATIENT THE NEXT DAY. SO WE CHANGED AGAIN THE CATHETER ON 05 SEPTEMBER 2022. WE OBSERVED THAT THE PATIENT WAS VERY POORLY DIALYZED. IT IMPROVED AFTERWARDS. THE COAGULATION MONITORING FOR THIS PATIENT FOR THIS PERIOD IS CORRECT. ADDITIONAL INFORMATION RECEIVED 28OCT2022: THE PATIENT IS FINE, BUT THE QUALITY OF DIALYSIS IS NOT GOOD. THE PATIENT HAD TO DO ADDITIONAL SESSIONS. PATIENT IS ELD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15783279 ↗
• MalfunctionNov 11, 2022Obstruction of Flow; Obstruction of Flow

  THE COMPLAINT IS REPORTED AS: CATHETER OBSTRUCTION WAS NOTED ON (B)(6) 2022. A PROTOCOL WITH THERASOLV 100000UI OF 30 MIN WAS DONE. THE PATIENT RETURNED THE NEXT DAY BECAUSE OF LOSS OF CIRCUIT AT THIS SESSION AND INCOMPLETE DIALYSIS. ON THE FOLLOWING SESSION, WE OBSERVED THAT A 3-HOUR THERASOLV PROTOCOL WAS PERFORMED BECAUSE THE CATHETER STILL DID NOT WORK PROPERLY. THE FOLLOWING SESSIONS SHOWED A VERY POOR QUALITY OF DIALYSIS AND THE CAUSE WAS THE CATHETER. (LOW CATHETER/V, LOW BLOOD FLOW). UNTIL MID-AUGUST, WE NOTICED SPECIFIC OBSTRUCTIONS, SOME PROCEDURES WERE ACTIONED TO UNBLOCK THEM. THE LINES WERE REVERSED DURING THE DIALYSIS SESSION, THERE WERE VERY NEGATIVE BLOOD PRESSURES, IT STOPPED THE BLOOD PUMP ON MANY OCCASIONS. ON (B)(6) 2022 THE CATHETER WAS CHANGED. IT WAS IMPOSSIBLE TO DIALYZE THE PATIENT THE NEXT DAY. SO WE CHANGED AGAIN THE CATHETER ON (B)(6) 2022. WE OBSERVED THAT THE PATIENT WAS VERY POORLY DIALYZED. IT IMPROVED AFTERWARDS. THE COAGULATION MONITORING FOR THIS PATIENT FOR THIS PERIOD IS CORRECT. ADDITIONAL INFORMATION RECEVIED 28OCT2022: THE PATIENT IS FINE, BUT THE QUALITY OF DIALYSIS IS NOT GOOD. THE PATIENT HAD TO DO ADDITIONAL SESSIONS. PATIENT IS ELDERLY A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15783066 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141051. One submission often covers many models, so check the product and lot details in each record.

• Z-2157-2026 · Apr 10, 2026 · Open, Classified
  Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFIE, CS-15232-VFI, CS-15232-VFIE, CS-15272