ARROW IPN923528Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902206647), received between Oct 26, 2022 and Oct 26, 2022 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT, THE USER INFLATED THE BALLOON DURING USE ON A PATIENT, BUT IT DEFLATED SOON. THEREFORE, THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER KIT. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY, OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15673052 ↗

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-0716-2020 · Nov 15, 2019 · Terminated
  Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
• Z-0715-2020 · Nov 15, 2019 · Terminated
  Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
• 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