ARROW IPN915244Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902160529), received between Apr 7, 2020 and Sep 28, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT "THE BALLOON INFLATED IN A DISTORTED SHAPE AFTER PLACEMENT. THE USER REMOVED THE CATHETER AND INFLATED THE BALLOON, BUT THE SAME ISSUE OCCURRED. THEREFORE, A NEW KIT WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH". PATIENT CONDITION REPORTED AS "FINE". ADDITIONAL INFORMATION STATED THAT THE SECOND CATHETER WAS INSERTED AT THE SAME INSERTION SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15498987 ↗
• MalfunctionJun 17, 2020Deflation Problem

  THE BALLOON WOULD NOT DEFLATE DURING TESTING. IT DID NOT GET USED ON THE PATIENT. EVENTUALLY IT DEFLATED AFTER IT WAS REPLACED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10161939 ↗
• MalfunctionApr 7, 2020Deflation Problem

  MIDDLE AGED FEMALE WITH HISTORY OF SHORTNESS OF BREATH AND PULMONARY HYPERTENSION. HAVING A HEART CATH AND THE SWAN CATHETER GOING TO BE USED FOR PROCEDURE WAS TESTED. BALLOON INFLATED BUT DID NOT DEFLATE FOR 6 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9932926 ↗

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