ARROW IPN919724Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801902190366), received between Apr 17, 2026 and May 19, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2026, "DURING HEMODIALYSIS TREATMENT, THE CATHETER BECAME KINKED, RESULTING IN INTERRUPTION OF THE DIALYSIS SESSION. THE DEVICE WAS REPLACED IMMEDIATELY." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE". NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED BEYOND REMOVAL OF THE AFFECTED DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING REPLACEMENT WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222570 ↗
• MalfunctionMay 14, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE USER OBSERVED THE SPRING WIRE GUIDE (SWG) TO BE BENT DURING INSERTION. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BEYOND REPLACEMENT WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178643 ↗
• MalfunctionApr 24, 2026Unraveled Material

  IT WAS REPORTED THAT "SWG UNRAVELED. THE PATIENT WAS REPORTED AS FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24977025 ↗
• MalfunctionApr 22, 2026Material Frayed

  IT WAS REPORTED THAT: "DURING A NORMAL IMPLANTATION OF THE CATHETER, UPON REMOVAL OF THE GUIDEWIRE, IT WAS FOUND TO BE DAMAGED AND FRAYED. THERE WAS RESISTANCE DURING REMOVAL, BUT IT WAS SUCCESSFULLY EXTRACTED. THE PATIENT EXPERIENCED NO COMPLICATIONS. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24952052 ↗
• MalfunctionApr 20, 2026Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT: "(B)(6) 2026, DURING THE PATIENT'S HEMODIALYSIS CATHETERIZATION PROCESS, THE DELIVERY OF THE GUIDEWIRE WENT SMOOTHLY. HOWEVER, AFTER THE SKIN EXPANSION AND INCISION, THE CATHETER WAS DIFFICULT TO ADVANCED ONTO THE SWG AND IT WAS FOUND THAT THE GUIDEWIRE WAS KINKED, IT DID NOT CAUSE ANY HARM TO THE PATIENT. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24923912 ↗
• MalfunctionApr 17, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "THE GUIDE WIRE KINKING. SWG WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24909913 ↗