ARROW IPN001350Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10801902127195), received between Mar 7, 2024 and Dec 3, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "CATHETER GOT LEAKED". AS A RESULT, THE CATHETER WAS REMOVED AND REPLACED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708315 ↗
• MalfunctionNov 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING DIALYSIS, THE PROXIMAL EXTENSION LUMEN WAS CUT BY THE PINCH CLAMP AND THERE WAS LEAKAGE OF BLOOD. AS A RESULT, A NEW CATHETER WAS INSERTED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23595747 ↗
• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED "IN MULTIPLE PATIENTS, VECTORFLOW HUB BREAKDOWN AND THE TIME BETWEEN TUBE PLACEMENT AND DROPOUT RANGED FROM HALF A MONTH TO SIX MONTHS." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00399, 9680794-2025-00400, AND 9680794-2025-00311.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900023 ↗
• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED "IN MULTIPLE PATIENTS, VECTOR FLOW HUB BREAKDOWN AND THE TIME BETWEEN TUBE PLACEMENT AND DROPOUT RANGED FROM HALF A MONTH TO SIX MONTHS." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00400, 9680794-2025-00401, AND 9680794-2025-00311.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900012 ↗
• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED "IN MULTIPLE PATIENTS, VECTORFLOW HUB BREAKDOWN AND THE TIME BETWEEN TUBE PLACEMENT AND DROPOUT RANGED FROM HALF A MONTH TO SIX MONTHS." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00399, 9680794-2025-00401, AND 9680794-2025-00311.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900005 ↗
• MalfunctionApr 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT "WE HAVE HAD TWO INCIDENTS WITH THE VECTORFLOW CATHETER. IN BOTH CASES, THE PEELABLE INTRODUCER, WHICH COMES WITH THE CATHETER KIT, BROKE. THERE ARE TWO UNITS. THE INCIDENT OCCURRED DURING SURGERY. THE PATIENT WAS NOT INJURED OR SUFFERED ANY ADVERSE CONSEQUENCES, NOR DID HE REQUIRE FURTHER MEDICAL INTERVENTION." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00314, 9680794-2025-00315, 9680794-2025-00330, AND 9680794-2025-00329.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21889319 ↗
• MalfunctionApr 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT "WE HAVE HAD TWO INCIDENTS WITH THE VECTORFLOW CATHETER. IN BOTH CASES, THE PEELABLE INTRODUCER, WHICH COMES WITH THE CATHETER KIT, BROKE. THERE ARE TWO UNITS. THE INCIDENT OCCURRED DURING SURGERY. THE PATIENT WAS NOT INJURED OR SUFFERED ANY ADVERSE CONSEQUENCES, NOR DID HE REQUIRE FURTHER MEDICAL INTERVENTION." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00314, 9680794-2025-00315, 9680794-2025-00330, AND 9680794-2025-00329.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21889258 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT "WE HAVE HAD TWO INCIDENTS WITH THE VECTORFLOW CATHETER. IN BOTH CASES, THE PEELABLE INTRODUCER, WHICH COMES WITH THE CATHETER KIT, BROKE. THERE ARE TWO UNITS. THE INCIDENT OCCURRED DURING SURGERY. THE PATIENT WAS NOT INJURED OR SUFFERED ANY ADVERSE CONSEQUENCES, NOR DID HE REQUIRE FURTHER MEDICAL INTERVENTION." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00314, 9680794-2025-00315, 9680794-2025-00330, AND 9680794-2025-00329.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21889115 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT "WE HAVE HAD TWO INCIDENTS WITH THE VECTORFLOW CATHETER. IN BOTH CASES, THE PEELABLE INTRODUCER, WHICH COMES WITH THE CATHETER KIT, BROKE. THERE ARE TWO UNITS. THE INCIDENT OCCURRED DURING SURGERY. THE PATIENT WAS NOT INJURED OR SUFFERED ANY ADVERSE CONSEQUENCES, NOR DID HE REQUIRE FURTHER MEDICAL INTERVENTION." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00314, 9680794-2025-00315, 9680794-2025-00330, AND 9680794-2025-00329.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21889069 ↗
• MalfunctionApr 16, 2025Break; Break

  IT WAS REPORTED, "WHEN THE NURSE DREW BACK THE ARTERIAL AND VENOUS END OF THE TUBING BEFORE BOARDING THE MACHINE, SHE FOUND THAT THE VECTORFLOW HUB WAS BROKEN DOWN , AND SHE WAS UNABLE TO CHECK THE VOLUME OF THE CATHETER." 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 21846924 ↗
• MalfunctionMar 12, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT "DURING THE INSERTION PROCEDURE, RESISTANCE WAS OBSERVED WHILE ADVANCING THE CATHETER AND PROCEDURE COULD NOT BE COMPLETED.". THERE WAS DELAY IN TREATMENT AND NO HARM OCCURRED TO THE PATIENT DUE TO THE CATHETER. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583343 ↗
• MalfunctionJan 29, 2025Material Separation; Separation Failure; Material Separation; Separation Failure

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE SMARTSEAL SHEATH VALVE DAMAGED 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. THE PEEL-AWAY SHEATH TABS WERE ALSO NOTED BROKEN. THE ASSOCIATED EMDR REPORT NUMBER 9680794-2025-00076.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264009 ↗
• MalfunctionJan 29, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE SMARTSEAL SHEATH VALVE DAMAGED 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 21263914 ↗
• MalfunctionDec 4, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED "ACCORDING TO THE DOCTOR THE BUTTERFLY SHEATH BROKEN AND HEMOSTATIC VALVE CAME OUT." THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20843386 ↗
• MalfunctionDec 3, 2024Insufficient Flow or Under Infusion; Material Twisted/Bent; Insufficient Flow or Under Infusion; Material Twisted/Bent

  IT WAS REPORTED "DOCTOR FOUND THE CATHETER TO BE KINKED AND THERE WAS INADEQUATE FLOW." THE DEVICE WAS REMOVED AND REPLACED. 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 20835397 ↗
• MalfunctionAug 1, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "08 JULY 2024, THE DOCTOR FOUND THE SWG KINKED PRIOR TO THE PATIENT. INVOLVED 1 PC."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19880425 ↗
• MalfunctionMar 7, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT: DILATOR WAS BROKEN AND SPLIT IN FRONT OF TIP PORTION DURING INSERTION. PATIENT IS FINE. ANOTHER DEVICE WAS USED FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18854156 ↗

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