ARROW IPN030063Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00801902100108), received between Jul 27, 2023 and Apr 11, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (9 reports).

1 other recall cover devices cleared under the same FDA submission (K895417); 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026Material Deformation; Material Too Soft/Flexible

  IT WAS REPORTED THAT "THE DILATOR IS TOO SOFT. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24850915 ↗
• MalfunctionApr 10, 2026Material Too Soft/Flexible

  IT WAS REPORTED THAT "THE DILATOR IS TOO SOFT. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY."

  Patient problems: Insufficient Information

  MAUDE report 24842887 ↗
• MalfunctionMar 30, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "THE GUIDE WIRE BENT." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727515 ↗
• MalfunctionFeb 25, 2026Dull, Blunt

  IT WAS REPORTED THAT: "THE TISSUE DILATOR FAILED TO PENETRATE DURING THE PROCEDURE (UNABLE TO PUNCTURE). THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24440254 ↗
• MalfunctionNov 28, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT: "ON (B)(6) 2025, THE DOCTOR FEELS THAT THE QUALITY OF PINCH CLAMP IS POOR, IT IS VERY LOOSE DURING USE ON THE PATIENT. INVOLVED 1 PC. CONFIRMED WITH THE CUSTOMER. THE PATIENT CONDITION IS FINE. NO HARM FOR THE PATIENT. THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO MEDICAL INTERVENTION WAS REQUIRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23670340 ↗
• MalfunctionAug 4, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "(B)(6) 2025, THE DOCTOR FOUND THE SWG KINKED PRIOR TO PATIENT." 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 22699931 ↗
• MalfunctionJun 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "SYRINGE LEAKAGE." THE DEVICE WAS REMOVED. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 22299346 ↗
• MalfunctionFeb 25, 2025Crack; Crack

  IT WAS REPORTED THAT "UPON USE ON A PATIENT WHEN DOCTOR TRIED TO ASPIRATE IT WAS NOTICED THAT THE INTRODUCER NEEDLE WAS LEAKING DUE TO A CRACK ON THE NEEDLE HUB. NEEDLE REMOVED AND NEW SET OPENED UP TO COMPLETE THE PROCEDURE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457425 ↗
• MalfunctionFeb 7, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE GUIDE WIRE BENT". THEY CHANGED A NEW SET TO COMPLETE THE PROCEDURE. THE PATIENT HAD NO HARM OR INJURY. THE ASSOCIATED EMDR REPORT NUMBERS ARE 3006425876-2025-00131 AND 3006425876-2025-00132.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332504 ↗
• MalfunctionJan 3, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "DURING THE INSERTION, THE DOCTOR FOUND THE SWG/ARS RESISTANCE, IT WAS FOUND THE SWG KINKED DURING USED ON THE PATIENT." A NEW ONE WAS USED 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 21066879 ↗
• MalfunctionDec 10, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED "ON (B)(6) 2024, IN EMERGENCY ROOM, THE DOCTOR FOUND THE SWG UNRAVELED DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895364 ↗
• MalfunctionAug 20, 2024Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT: " ON (B)(6) 2024, THE DOCTOR FOUND THE SWG DIFFICULT TO REMOVE FROM THE CATHETER, FINALLY THE DOCTOR REMOVE THE SWG AND CATHETER TOGETHER, THE SWG WAS FOUND KINKED DURING USED ON THE PATIENT. INVOLVED 1 PC. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20001215 ↗
• MalfunctionMay 28, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "THE DOCTOR FOUND THE DILATOR HUB DAMAGED DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. 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 19403931 ↗
• MalfunctionMay 28, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "THE DOCTOR FOUND THE DILATOR HUB DAMAGED DURING USED ON THE SAME PATIENT." THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. 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 19403921 ↗
• MalfunctionMay 1, 2024Material Separation; Material Separation

  IT WAS REPORTED "IN THE EMERGENCY ROOM, THE DOCTOR FOUND THE SWG UNRAVELED DURING USED ON THE PATIENT." THE USER CHANGED TO A NEW SET. 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 19219836 ↗
• MalfunctionApr 30, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: " ON (B)(6) 2024, IN ICU, THE DOCTOR FOUND THE SWG KINKED DURING USE ON THE PATIENT. THE PATIENT WAS REPORTED AS FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211630 ↗
• MalfunctionApr 29, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "IN ICU, THE DOCTOR FOUND THE SWG KINKED DURING USE ON THE PATIENT." 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 19202430 ↗
• MalfunctionMar 4, 2024Unraveled Material; Material Twisted/Bent; Unraveled Material; Material Twisted/Bent

  IT WAS REPORTED THAT" ON (B)(6) 2024, THE DOCTOR FOUND THE SWG KINKED DURING USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18824817 ↗
• MalfunctionFeb 29, 2024Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  IT WAS REPORTED "THE DILATOR WAS FOUND BLOCKED DURING USED ON THE PATIENT." NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18806676 ↗
• MalfunctionFeb 14, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "ONE OF SWG WAS FAULTY AND CANNOT USED (BENT), AND THEN REQUIRED A NEW SET" THE CURRENT STATUS OF THE PATIENT IS "UNKNOWN" AT THS TIME. THE CUSTOMER HAS NOT RETURNED OUR REQUEST FOR ADDITIONAL INFORMATION AT THIS TIME .

  Patient problems: Insufficient Information

  MAUDE report 18707258 ↗
• MalfunctionFeb 2, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "ON (B)(6) 2023, THE DOCTOR FOUND THE ARS LEAKING DURING USE ON THE PATIENT. THE PATIENT WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18633871 ↗
• MalfunctionFeb 2, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT" ON (B)(6) 2023, THE DOCTOR FOUND THE ARS LEAK DURING USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18633544 ↗
• MalfunctionFeb 2, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT" ON (B)(6) 2023, THE DOCTOR FOUND THE ARS LEAK DURING USED ON THE PATIENT. PATIENT WAS REPORTED AS FINE POST THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18632166 ↗
• MalfunctionDec 27, 2023Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IT WAS REPORTED THAT "THE SWG WAS FOUND SEPARATED DURING USED ON THE PATIENT". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18401687 ↗
• MalfunctionDec 11, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT"(B)(6) 2023, THE ARS WAS FOUND LEAK DURING USED ON THE PATIENT. THE PATIENT WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18299837 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K895417. One submission often covers many models, so check the product and lot details in each record.

• Z-2381-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F