ARROW IPN030072Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801902100122), received between Jul 12, 2023 and May 2, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K991431); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT " DURING DIALYSIS CATHETER INSERTION IT WAS IMPOSSIBLE TO REMOVE THE GUIDE. THE CONSEQUENCES WERE PAIN FOR THE PATIENT." A NEW PUNCTURE KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE."

  Patient problems: Pain

  MAUDE report 21950155 ↗
• MalfunctionApr 23, 2025Difficult to Remove; Difficult to Advance; Physical Resistance/Sticking; Difficult to Remove; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED "DURING INSERTION THE GUIDE WAS IMPOSSIBLE TO ADVANCE, AND IT GOT STUCK, IT WAS IMPOSSIBLE TO REMOVE. THE DEVICE WAS REPLACED." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATES "RESISTANCE WAS OBSERVED WHEN I TRIED TO LOWER THE GUIDE INTO THE NEEDLE, PROMPTING ME TO MOVE THE NEEDLE. I THOUGHT IT WAS BLOCKED AGAINST THE WALL, SO I REPOSITIONED MY NEEDLE, WITHOUT SUCCESS. SO I WANTED TO REMOVE THE GUIDE TO SEE IF THERE WAS STILL BLOOD REFLUX AND CHECK THAT THE NEEDLE WAS STILL IN THE VEIN, BUT I COULDN'T REMOVE THE GUIDE AND HAD TO REMOVE THE GUIDE AND NEEDLE." THE DEVICE WAS REMOVED, AND A NEW SET WAS USED REQUIRING THE PATIENT TO BE RE-PUNCTURED THREE TIMES WHICH RESULTED IN A HEMATOMA. THE THIRD INSERTION WAS A SUCCESS. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DECEASED". THE CUSTOMER REPORTS "PATIENT DECEASED WITHIN THE FIRST 48 HOURS OF TREATMENT (DEATH HAS NO LINK WITH THE INCIDENT)."

  Patient problems: Hematoma; Needle Stick/Puncture

  MAUDE report 21889725 ↗
• MalfunctionJan 2, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT "SWG DEFECTIVE STUCK IN NEEDLE". ADDITIONAL INFORMATION REPORTED THAT THE GUIDEWIRE WAS "SKEWERED" BY THE PUNCTURE NEEDLE, MAKING IT IMPOSSIBLE TO DISASSEMBLE. AS A RESULT, ANOTHER GUIDEWIRE HAD TO RESOLVE THE ISSUE. THE PATIENT IS FINE AND HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21055040 ↗
• MalfunctionJun 10, 2024Unraveled Material; Fitting Problem; Unraveled Material; Fitting Problem

  IT WAS REPORTED "THE WIRE IS TOO THICK FOR THE ARS AND IT SOMETIMES MEETS WITH RESISTANCE BEFORE THE WIRE EVEN EXITS THE TIP OF NEEDLE". ADDITIONAL INFORMATION REPORTS, THE GUIDEWIRE GOT STUCK IN THE SYRINGE ONCE THE WIRE UNRAVELLED. THE DEVICE WAS REMOVED. 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 19497788 ↗
• MalfunctionJun 10, 2024Unraveled Material; Fitting Problem; Unraveled Material; Fitting Problem

  IT WAS REPORTED "THE WIRE IS TOO THICK FOR THE ARS AND IT SOMETIMES MEETS WITH RESISTANCE BEFORE THE WIRE EVEN EXITS THE TIP OF NEEDLE". ADDITIONAL INFORMATION REPORTS, THE GUIDEWIRE GOT STUCK IN THE SYRINGE ONCE THE WIRE UNRAVELLED. THE DEVICE WAS REMOVED. 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 19497755 ↗
• MalfunctionJun 10, 2024Unraveled Material; Fitting Problem; Unraveled Material; Fitting Problem

  IT WAS REPORTED "THE WIRE IS TOO THICK FOR THE ARS AND IT SOMETIMES MEETS WITH RESISTANCE BEFORE THE WIRE EVEN EXITS THE TIP OF NEEDLE". ADDITIONAL INFORMATION REPORTS, THE GUIDEWIRE GOT IN THE STUCK SYRINGE ONCE THE WIRE UNRAVELLED. THE DEVICE WAS REMOVED. 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 19497683 ↗
• MalfunctionMay 29, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED "GUIDEWIRE BROKE OFF IN THE RAULERSON SYRINGE". THE DEVICE WAS REMOVED. 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 19418343 ↗
• MalfunctionJul 12, 2023Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  DURING THE INSERTION OF THE CATHETER, "THE NEEDLE UNRAVELED THE SWG DURING REMOVAL". THE PHYSICIAN SLOWLY REMOVED THE CATHETER AND GUIDEWIRE TOGETHER AND ANOTHER DEVICE WAS USED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17304819 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K991431. One submission often covers many models, so check the product and lot details in each record.

• Z-0639-04 · Feb 18, 2004 · Terminated
  Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high Volume Ifusions