ARROW IPN917237Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902180800), received between Feb 16, 2023 and Aug 8, 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.

• MalfunctionAug 8, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE BALLOON DID NOT INFLATE DURING USE ON A PATIENT. THEREFORE, THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER KIT, INSERTED AT THE SAME SITE. THE REPLACED ONE INFLATED NORMALLY AND THE PROCEDURE WAS COMPLETED WITHOUT PROBLEM." NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17482367 ↗
• MalfunctionFeb 16, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  "IT WAS REPORTED THAT THE LUMEN OF THE CATHETER FOR INJECTING CONTRAST GOT TORN DURING USE, IN SPITE THAT THE CONTRAST WAS BEING INJECTED AT THE PROPER INJECTION PRESSURE. THEREFORE, THE CATHETER WAS REPLACED WITH A NEW ONE AND INSERTED AT THE SAME INSERTION SITE TO COMPLETE 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 16389665 ↗

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