ARROW IPN001179Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10801902112870), received between Oct 17, 2023 and Jan 7, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Gas/Air 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJan 7, 2026Crack; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT: "A CRACK WAS FOUND ON THE COMPRESSION SLEEVE DURING USE. THE USER TRIED TO CONNECT IT TO THE HUB CONNECTION ASSEMBLY, BUT FELT RESISTANCE. THEREFORE, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OCCURRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987878 ↗
• MalfunctionJul 28, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE CATHETER WAS FOUND KINKED BY X-RAY AFTER PLACEMENT. THEREFORE, IT WAS REMOVED AND REPLACED WITH A NEW ONE, AT WHICH NO KINK WAS FOUND AFTER THAT. NO INJURY TO THE PATIENT 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 22629826 ↗
• MalfunctionMay 7, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "AFTER CONNECTION OF THE CVC FOR DIALYSIS TO THE EXTRACORPOREA CIRCULATION, ABUNDANT AIR ENTRY IS EVIDENCED INTO THE CIRCUIT DUE TO ASPIRATION FROM A POINT OF THE BRANCHES (BREAK) NOT EVIDENCEABLE BY VISUAL INSPECTION." THE CUSTOMER USED A REPAIR KIT. 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 21975814 ↗
• MalfunctionMay 6, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "AFTER CONNECTION OF THE CVC FOR DIALYSIS TO THE EXTRACORPOREA CIRCULATION, ABUNDANT AIR ENTRY IS EVIDENCED INTO THE CIRCUIT DUE TO ASPIRATION FROM A POINT OF THE BRANCHES (BREAK) NOT EVIDENCEABLE BY VISUAL INSPECTION." A REPAIR KIT WAS USED. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00378 AND 9680794-2025-00379.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967295 ↗
• MalfunctionMay 6, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "AFTER CONNECTION OF THE CVC FOR DIALYSIS TO THE EXTRACORPOREA CIRCULATION, ABUNDANT AIR ENTRY IS EVIDENCED INTO THE CIRCUIT DUE TO ASPIRATION FROM A POINT OF THE BRANCHES (BREAK) NOT EVIDENCEABLE BY VISUAL INSPECTION." THE PROCEDURE WAS POSTPONED. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00379.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967278 ↗
• MalfunctionFeb 18, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, AFTER INSERTION OF THE CATHETER, IT WAS FOUND KINKED AROUND THE MIDDLE BY ANGIOGRAPHY. THEREFORE, IT WAS REMOVED AND REPLACED WITH A NEW ONE. THERE WAS NO PROBLEM IN THE REPLACED (2ND INSERTED) CATHETER BY ANGIOGRAPHY. NO INJURY TO THE PATIENT OCCURRED. THE INSERTION SITE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21400035 ↗
• MalfunctionDec 10, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE CONTEXT WAS A HEMODIALYSIS CATHETER WAS INSERTED WITH SUCCESS IN THE PATIENT. THE TEST OF THE CATHETER WAS OK. PATIENT HAD THE HEMODIALYSIS. MACHINE STATED THAT THE CATHETER HAD AN ISSUE. WHEN PATIENT CAME BACK FROM HEMODIALYSIS, IT WAS OBSERVED THE CATHETER WAS KINKED. PATIENT IS FINE, NO MEDICAL INTERVENTION NECESSARY, NO CONSEQUENCE FOR THE PATIENT." THIS DOCTOR REPORTED THAT A SIMILAR ISSUE HAD ALREADY HAPPENED 2 OR 3 OTHER TIMES WITH THIS REFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894330 ↗
• MalfunctionNov 27, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: WHEN THE USER ASPIRATED BLOOD FROM BLUE LINE OF THE IRRIGATION TUBE WITH A SYRINGE, NOT ONLY BLOOD BUT ALSO AIR WAS ASPIRATED. (NO AIR WAS ASPIRATED FROM RED LINE.) IT OCCURRED TO BOTH CATHETERS. (ASSOCIATED TO 9680794-2023-00916). NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208546 ↗
• MalfunctionNov 27, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: WHEN THE USER ASPIRATED BLOOD FROM BLUE LINE OF THE IRRIGATION TUBE WITH A SYRINGE, NOT ONLY BLOOD BUT ALSO AIR WAS ASPIRATED. (NO AIR WAS ASPIRATED FROM RED LINE.) IT OCCURRED TO BOTH CATHETERS. (ASSOCIATED TO 9680794-2023-00917). NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208524 ↗
• MalfunctionNov 27, 2023Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT; AFTER PLACEMENT OF THE CATHETER TO THE PATIENT, THE USER WAS UNABLE TO CONNECT THE WHITE COMPRESSION CAP OF THE TUNNELER TO THE IRRIGATION TUBE, AS THE CAP WAS LOOSE. THEREFORE, THE USER REMOVED THE CATHETER AND REPLACED WITH A NEW ONE. AFTER INSERTING THE NEW CATHETER WITHOUT PROBLEM, THE USER ATTEMPTED TO CONNECT THE WHITE COMPRESSION CAP OF THE TUNNELER TO THE IRRIGATION TUBE, BUT HE/SHE WAS UNABLE TO TIGHTEN THE CAP SCREW COMPLETELY AGAIN. (THE CAP SCREW STOPPED AT ABOUT 90% AND COULD NOT BE TIGHTENED FURTHER.) THEREFORE, THE CATHETER WAS REMOVED AND REPLACED WITH THE THIRD ONE TO COMPLETE THE PROCEDURE. ASSOCIATED TO 9680794-2023-00914. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208485 ↗
• MalfunctionNov 27, 2023Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT; AFTER PLACEMENT OF THE CATHETER TO THE PATIENT, THE USER WAS UNABLE TO CONNECT THE WHITE COMPRESSION CAP OF THE TUNNELER TO THE IRRIGATION TUBE, AS THE CAP WAS LOOSE. THEREFORE, THE USER REMOVED THE CATHETER AND REPLACED WITH A NEW ONE. AFTER INSERTING THE NEW CATHETER WITHOUT PROBLEM, THE USER ATTEMPTED TO CONNECT THE WHITE COMPRESSION CAP OF THE TUNNELER TO THE IRRIGATION TUBE, BUT HE/SHE WAS UNABLE TO TIGHTEN THE CAP SCREW COMPLETELY AGAIN. (THE CAP SCREW STOPPED AT ABOUT 90% AND COULD NOT BE TIGHTENED FURTHER.) THEREFORE, THE CATHETER WAS REMOVED AND REPLACED WITH THE THIRD ONE TO COMPLETE THE PROCEDURE. ASSOCIATED TO 9680794-2023-00915. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208462 ↗
• MalfunctionOct 17, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THE CATHETER "FELL OUT THE SAME DAY THE STITCHES WERE REMOVED BECAUSE THE CUFF DIDN'T GROW INTO THE TISSUE, INFLAMMATION IS NOT PRESENT". THE ISSUE OCCURRED MORE THAN 30 DAYS AFTER INSERTION. NO PATIENT HARM OR INJURY WAS REPORTED AND NO SIGNS OF LOCAL OR SYSTEMIC INFECTION WERE OBSERVED. NO MEDICAL INTERVENTION WAS REQUIRED. A NEW CATHETER WAS INSERTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949228 ↗
• MalfunctionOct 17, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THE CATHETER "FELL OUT THE SAME DAY THE STITCHES WERE REMOVED BECAUSE THE CUFF DIDN'T GROW INTO THE TISSUE, INFLAMMATION IS NOT PRESENT". THE ISSUE OCCURRED MORE THAN 30 DAYS AFTER INSERTION. NO PATIENT HARM OR INJURY WAS REPORTED AND NO SIGNS OF LOCAL OR SYSTEMIC INFECTION WERE OBSERVED. NO MEDICAL INTERVENTION WAS REQUIRED. A NEW CATHETER WAS INSERTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949198 ↗
• MalfunctionOct 17, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THE CATHETER "FELL OUT THE SAME DAY THE STITCHES WERE REMOVED BECAUSE THE CUFF DIDN'T GROW INTO THE TISSUE, INFLAMMATION IS NOT PRESENT". THE ISSUE OCCURRED MORE THAN 30 DAYS AFTER INSERTION. NO PATIENT HARM OR INJURY WAS REPORTED AND NO SIGNS OF LOCAL OR SYSTEMIC INFECTION WERE OBSERVED. NO MEDICAL INTERVENTION WAS REQUIRED. A NEW CATHETER WAS INSERTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949144 ↗
• MalfunctionOct 17, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THE CATHETER "FELL OUT THE SAME DAY THE STITCHES WERE REMOVED BECAUSE THE CUFF DIDN'T GROW INTO THE TISSUE, INFLAMMATION IS NOT PRESENT". THE ISSUE OCCURRED MORE THAN 30 DAYS AFTER INSERTION. NO PATIENT HARM OR INJURY WAS REPORTED AND NO SIGNS OF LOCAL OR SYSTEMIC INFECTION WERE OBSERVED. NO MEDICAL INTERVENTION WAS REQUIRED. A NEW CATHETER WAS INSERTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17948967 ↗

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