ARROW IPN032602Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801902097903), received between Mar 4, 2024 and Dec 26, 2025 — 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. 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.

• MalfunctionDec 26, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "DOCTOR ATTEMPTED TO INSERT THE CAVITY DRAIN, EVERY TIME HE TRIED TO THREAD THE GUIDE WIRE IT KINKED. HE THEN OPENED A SECOND SET AND THERE WAS THE SAME OUTCOME. HE EVENTUALLY OPENED THE CVC SET JUST TO TAKE OUT THE GUIDE WIRE AND HE USED THAT AND IT WAS SUCCESSFUL". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896308 ↗
• MalfunctionDec 26, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "DOCTOR ATTEMPTED TO INSERT THE CAVITY DRAIN, EVERY TIME HE TRIED TO THREAD THE GUIDE WIRE IT KINKED. HE THEN OPENED A SECOND SET AND THERE WAS THE SAME OUTCOME. HE EVENTUALLY OPENED THE CVC SET JUST TO TAKE OUT THE GUIDE WIRE AND HE USED THAT AND IT WAS SUCCESSFUL". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896302 ↗
• MalfunctionSep 5, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE DOCTOR INSERTED NEEDLE AND SYRINGE AS SOON AS HE STARTED THREADING THE GUIDEWIRE THE GUIDEWIRE KINKED. THE DEVICE REMOVED ENTIRELY, MADE TWO ATTEMPTS, THIRD ATTEMPT WAS SUCCESSFUL BUT THERAPY GOT DELAYED." IT WAS REPORTED THERE WAS NO HARM TO THE PATIENT DUE TO THE DEVICE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2024-00857.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146054 ↗
• MalfunctionSep 3, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THEY OPENED THE ITEM, BUT THE INTRODUCER GUIDEWIRE WAS FAULTY, AND THEY COULD NOT USE THE SPECIFIC WIRE , BECAUSE THEY COULDN'T GAIN ACCESS INTO CAVITY." ADDITIONAL INFORMATION RECEIVED REPORTS THE GUIDEWIRE WAS KINKED. THE DEVICE WAS REMOVED AND REPLACED. 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 20127444 ↗
• MalfunctionSep 2, 2024Crack; Device Damaged Prior to Use; Crack; Device Damaged Prior to Use

  IT WAS REPORTED THAT: "ON 21/5/2024 DR (PULMONOGIST) OPENED PACK TO USE ON PATIENT AND NOTED NEEDLE BROKEN IN SET. PACKAGING WAS NOT DAMAGED." THE RETURNED DEVICE SHOWED A CRACK IN THE NEEDLE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20117116 ↗
• MalfunctionMar 4, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT: PATIENT HAD DRAIN FOR PLEURAL EFFUSION AND THE CATHETER SLIPPED OUT THROUGH THE TIED DOWN WINGS. CATHETER WAS FOUND IN BED AND WINGS STILL SUTURED TO SKIN. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THE PATIENT WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18824752 ↗