ARROW IPN923525Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902206722), received between Jan 5, 2023 and Jun 12, 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.

• MalfunctionJun 12, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE BALLOON INFLATED NORMALLY DURING THE INFLATION TEST BEFORE USE. HOWEVER, IT DID NOT INFLATE ENOUGH AFTER THE CATHETER WAS INSERTED INTO THE PATIENT. THEREFORE, IT WAS REMOVED AND REPLACED WITH A NEW KIT OF THE SAME LOT, INSERTED AT THE SAME INSERTION SITE. THE REPLACED CATHETER INFLATED WITHOUT PROBLEM AND THE PROCEDURE WAS COMPLETED". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17111886 ↗
• MalfunctionJan 5, 2023Leak/Splash; Leak/Splash

  THE REPORT STATES, "IT WAS REPORTED THAT THE INFLATION TEST WAS DONE WITHOUT PROBLEM. HOWEVER, WHEN THE HIGH PRESSURE (600PSI) 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." FURTHER INFORMATION STATES THAT THE SECOND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16104654 ↗

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