ARROW IPN923524Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902206715), received between Mar 14, 2023 and Mar 27, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT CATHETER WAS TESTED BEFORE INSERTION, AND NO PROBLEM OCCURRED AT THE TIME. HOWEVER, THE BALLOON INFLATED ASYMMETRICALLY DURING USE ON A PATIENT. THEREFORE, A 2ND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16619997 ↗
• MalfunctionMar 14, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT "THE BALLOON INFLATED ASYMMETRICALLY DURING USE. THEREFORE, THE USER REMOVED THE CATHETER AND OPENED A NEW KIT BUT THE SAME ISSUE OCCURRED DURING THE INFLATION TEST, CONSECUTIVELY TO THREE KITS IN TOTAL. SO, THE FIFTH KIT WAS USED, INSERTED AT THE SAME INSERTION SITE WITH THE FIRST ONE TO COMPLETE THE PROCEDURE". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538905 ↗

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