ARROW IPN923531Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902206678), received between Jan 11, 2023 and Feb 16, 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.

• MalfunctionFeb 16, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BALLOON PASSED THE INFLATION TEST PRIOR TO USE, HOWEVER THE BALLOON RUPTURED INSIDE THE PATIENT WHILE IN USE. AS A RESULT, THE BALLOON WAS REMOVED AND A 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. NO HARM OR INJURY TO THE PATIENT. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16387817 ↗
• MalfunctionJan 11, 2023Inflation Problem; Inflation Problem

  THE REPORT STATES THAT "IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE FROM THE FIRST INFLATION DURING USE. THEREFORE, THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER CATHETER FROM A NEW KIT, WHICH WAS INSERTED AT THE SAME INSERTION SITE. THERE WAS NO PROBLEM DURING THE INFLATION TEST AND WHEN INSERTING THE CATHETER." NO REPORT OF PATIENT HARM OR INJURY. PATIENT STATUS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16141140 ↗

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