ARROW IPN001172Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801902112801), received between Aug 9, 2023 and Apr 16, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2025Material Separation; Material Separation

  IT WAS REPORTED "IN ORDER TO INSERT CATHETER, SKIN INCISION WAS MADE. EVERYTHING WAS GOING WELL UNTIL SMARTSEALHEMOSTATIS DIALYSIS SHEATH WAS INTRODUCED. SHEATH WAS DAMAGED. WING OF SHEATH TORE OFF. PROCEDURE WAS COMPLETED BECAUSE TOOL WAS TAKEN TO HOLD SHEATH WITHOUT WING. AND SHEATH TORE OFF IN VESSEL. AFTER COMPLETED PROCEDURE, CATHETER WAS PATENT, FUNCTIONAL. X-RAY OF CATHETER TIP WAS CHECKED. CORRECTLY POSITIONED." THE SHEATH WAS COMPLETELY REMOVED. THERE WAS NO DELAY TO THERAPY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21846775 ↗
• MalfunctionJan 21, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE PHYSICIAN IDENTIFIED A MALFUNCTION WITH THE LOCKING HUB DURING CHRONIC HEMODIALYSIS CATHETER PLACEMENT AT RIGHT INTERNAL JUGULAR VEIN UNDER FLUOROSCOPY GUIDANCE. THE ISSUE WAS RESOLVED BY INSERTING A NEW CATHETER. THERE WAS NO THERAPY DELAY OR PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21195703 ↗
• MalfunctionMay 20, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "EVERYTHING DURING PROCEDURE WENT OK BUT ON THE CONTROL X RAY THERE IS A SMALL KINK SHOWING." THERE WAS NO DELAY TO THERAPY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352926 ↗
• MalfunctionMay 14, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "EVERYTHING DURING PROCEDURE WENT OK BUT ON THE CONTROL X RAY THERE IS A SMALL KINK SHOWING (PLEASE SEE PICTURE). CATHETER WAS WELL ACCESSIBLE THOUGH, SO THEY DECIDED NOT TO REMOVE / REPLACE IT." THE PATIENT HAD NO REPORTED HARM OR CONSEQUENCE BECAUSE OF THE KINK AND WERE REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19308289 ↗
• MalfunctionDec 18, 2023Material Separation; Material Separation

  IT WAS REPORTED, THAT EARLY IN THE PROCEDURE. WHEN INSERTING THE SHEATH, THE PEEL AWAY PORTION BROKE APART AND WAS LODGED IN THE PATIENT. THIS PORTION HAD TO BE REMOVED BEFORE PROCEEDING. OCCURRED, DURING INSERTION IN THE INT/EXT JUGULA IN THE MEDICAL IMAGING DEPARTMENT. THE DEVICE WAS REMOVED IN IT ENTIRETY AND WAS REPLACED. THE PATIENT WAS REPORTED, AS FINE POST THE PROCEDURE.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18347059 ↗
• MalfunctionAug 9, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE CATHETER KINKED DURING PLACEMENT. THEREFORE, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW KIT. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494729 ↗

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