ARROW IPN000069Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801902002846), received between Nov 4, 2020 and Feb 9, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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.

• MalfunctionFeb 9, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED "THE BALLOON DID NOT INFLATE ENOUGH DURING AN INFLATION TEST BEFORE USE. THEREFORE, A NEW KIT OF THE SAME LOT WAS OPENED INSTEAD, WHICH INFLATED PROPERLY DURING A TEST. HOWEVER, WHEN THE CATHETER WAS USED ON THE PATIENT, THE BALLOON DID NOT INFLATE ENOUGH. AS THE PRODUCT WAS OUT OF STOCK, THE PROCEDURE WAS TERMINATED. NO INJURY TO THE PATIENT WAS REPORTED." PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18681644 ↗
• MalfunctionFeb 8, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED " DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND THE BALLOON COULD NOT PASS FOLLOWING THE WIRE. SO THE MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE." NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18672745 ↗
• MalfunctionNov 4, 2020Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT STAFF WAS UNABLE TO ADVANCE THE WIRE THROUGH THE END. AS A RESULT, A NEW CATHETER WAS USED. NO INFORMATION WAS ABLE TO BE OBTAINED REGARDING THE PATIENT.

  Patient problems: No Information

  MAUDE report 10784774 ↗

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