ARROW IPN923529Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902206654), received between Dec 5, 2022 and Jan 5, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K892530); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  "IT WAS REPORTED THAT RVG WAS PERFORMED WITHOUT PROBLEM. HOWEVER, WHEN THE CONTRAST AGENT WAS INJECTED DURING PAG, THE AGENT SUDDENLY SPLATTERED. ON CHECKING, THE BASE OF THE CATHETER WAS FOUND TORN. THEREFORE, THE CATHETER WAS REPLACED WITH A NEW ONE. NO HARM TO THE PATIENT OCCURRED." NO MEDICAL INTERVENTION NEEDED. IT IS UNKNOWN IF THE SECOND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16101489 ↗
• MalfunctionDec 22, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CATHETER NEAR THE BALLOON GOT BROKEN DURING THE PROCEDURE, PROBABLY BECAUSE THE CONTRAST AGENT FLOWED INTO THE BALLOON. THEREFORE, THE CATHETER WAS REPLACED THROUGH THE SAME SITE WITH A NEW ONE. NO HARM TO THE PATIENT WAS REPORTED AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16034301 ↗
• MalfunctionDec 19, 2022Leak/Splash; Leak/Splash

  THE REPORT STATES "IT WAS REPORTED THAT THE INFLATION TEST WAS DONE WITHOUT PROBLEM. HOWEVER, WHEN THE HIGH PRESSURE (520PSI) WAS INJECTED WITH AN INJECTOR, THE CATHETER GOT RUPTURED. THEREFORE, IT WAS REPLACED WITH A NEW ONE. NO HARM TO THE PATIENT WAS REPORTED. ACCORDING TO THE USER, HE/SHE HAD BEEN ABLE TO USE THE SAME PRODUCTS WITHOUT PROBLEM UNDER THE SAME CONDITION UNTIL THEN." ADDITIONAL INFORMATION STATES THAT THE SECOND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16006294 ↗
• MalfunctionDec 5, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CATHETER WAS FOUND TORN NEAR THE HUB DURING THE PROCEDURE. THE CATHETER WAS REPLACED WITH A NEW ONE AT THE SAME INSERTION SITE. THE USER DID NOT NOTICE THE TEAR AT THE BEGINNING OF THE PROCEDURE. NO HARM TO THE PATIENT WAS REPORTED. PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15919576 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K892530. One submission often covers many models, so check the product and lot details in each record.

• Z-0715-2020 · Nov 15, 2019 · Terminated
  Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
• Z-0716-2020 · Nov 15, 2019 · Terminated
  Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
• Z-1057-2013 · Mar 4, 2013 · Terminated
  Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic Catheter is indicated for use in ri