ARROW IPN036977Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 30801902120121), received between Feb 7, 2022 and Feb 25, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (K870572); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "INTRODUCER CATHETER FOLDED BACK ONTO ITSELF PREVENTING ADVANCEMENT. UPON REMOVAL THE CATHETER WAS FOUND TO BE INTACT BUT FOLDED. THERE WAS PATIENT INVOLVEMENT, NO HARM, NO MEDICAL INTERVENTION, PATIENT IS DOING WELL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442671 ↗
• MalfunctionDec 1, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT: "ONE WAY VALVE MALFUNCTIONED, COULD NOT DRAIN FLUID INTO COLLECTING BAG. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678149 ↗
• MalfunctionMay 17, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "THEIR ISSUE WAS WITH THE CATHETER THREADING OFF THE NEEDLE. THEY INSERT THE NEEDLE INTO THE PATIENT, AND THEN WHEN ATTEMPTING TO THREAD THE CATHETER OFF, THE CATHETER 'BUNCHES UP' AND IS UNABLE TO PASS INTO THE BODY." ANOTHER CATHETER WAS USED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345715 ↗
• MalfunctionMay 17, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "THEIR ISSUE WAS WITH THE CATHETER THREADING OFF THE NEEDLE. THEY INSERT THE NEEDLE INTO THE PATIENT, AND THEN WHEN ATTEMPTING TO THREAD THE CATHETER OFF, THE CATHETER 'BUNCHES UP' AND IS UNABLE TO PASS INTO THE BODY." NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345597 ↗
• MalfunctionMay 17, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "THEIR ISSUE WAS WITH THE CATHETER THREADING OFF THE NEEDLE. THEY INSERT THE NEEDLE INTO THE PATIENT, AND THEN WHEN ATTEMPTING TO THREAD THE CATHETER OFF, THE CATHETER 'BUNCHES UP' AND IS UNABLE TO PASS INTO THE BODY." NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345475 ↗
• MalfunctionMay 17, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "THEIR ISSUE WAS WITH THE CATHETER THREADING OFF THE NEEDLE. THEY INSERT THE NEEDLE INTO THE PATIENT, AND THEN WHEN ATTEMPTING TO THREAD THE CATHETER OFF, THE CATHETER 'BUNCHES UP' AND IS UNABLE TO PASS INTO THE BODY." NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345385 ↗
• MalfunctionMay 17, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "THEIR ISSUE WAS WITH THE CATHETER THREADING OFF THE NEEDLE. THEY INSERT THE NEEDLE INTO THE PATIENT, AND THEN WHEN ATTEMPTING TO THREAD THE CATHETER OFF, THE CATHETER 'BUNCHES UP' AND IS UNABLE TO PASS INTO THE BODY." NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345256 ↗
• MalfunctionAug 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "AFTER THE CATHETER WAS PLACED IN THE PATIENTS PLEURAL SPACE THE PHYSICIAN NOTICED THERE WAS AN INCREASING LEAK COMING FROM THE DEVICE. THE PHYSICIAN WITH ASSISTANCE WAS ABLE TO KEEP THE PROCEDURE GOING. THE PHYSICIAN NEEDED TO HAVE ASSISTANCE BY HAVING SOMEONE WITHDRAW PLEURAL FLUID WITH THE 50CC SYRINGE WHILE HE HELD THE BROKEN STOPCOCK PIECE TOGETHER. HE WAS ABLE TO COMPLETE THE PROCEDURE BUT SINCE THE SYSTEM WAS NOT TOTALLY INTACT HE WAS UNABLE TO SEND THE FLUID FOR CULTURES. THE PATIENT DID NOT APPEAR TO HAVE ANY COMPLICATIONS WITH THE PROCEDURE. THE PHYSICIAN EXPLAINED THE SITUATION TO THE PATIENT AND GIVEN FOLLOW UP INSTRUCTIONS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17537701 ↗
• InjuryFeb 7, 2022Break; Break

  COMPLAINT FOUND IN MAUDE DATABASE REPORTS: NURSE PRACTITIONER WAS PERFORMING THORACENTESIS ON PATIENT. AS SHE WENT TO REMOVE GUIDE NEEDLE, A PIECE OF THE VALVE BROKE OFF THE CATHETER. THUS AN UNDETERMINED AMOUNT OF AIR WAS SUCKED INTO THE CATHETER INTO THE PATIENT'S PLEURAL SPACE. THE NURSE PRACTITIONER WAS ABLE TO MANUALLY REMOVE THE AIR BY CONNECTING A SYRINGE ONTO THE BROKEN PIECE ON THE CATHETER.

  Patient problems: Air Embolism

  MAUDE report 13475648 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K870572. One submission often covers many models, so check the product and lot details in each record.

• Z-1966-2018 · Apr 11, 2018 · Terminated
  Maximal Barrier Drape; Product Code: ASK-01000-UPMS
• Z-1298-2018 · Oct 24, 2017 · Terminated
  ArrowClarke" PleuraSeal Thoracentesis Kit