ARROW IPN000084Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801902002280), received between Jul 6, 2021 and May 15, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED "THE BALLOON GOT RUPTURED DURING USE. THEREFORE, A NEW DEVICE WAS USED INSTEAD". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027364 ↗
• MalfunctionMar 21, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED " THE BALLOON DID NOT INFLATE DURING USE ON A PATIENT. THEREFORE, THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER KIT, AND COMPLETED THE PROCEDURE. NO HARM TO THE PATIENT WAS REPORTED. THE BALLOON INFLATED WITHOUT ANY PROBLEMS DURING THE PRE-PROCEDURAL IN VITRO INFLATION TEST AND THE INITIAL IN-VIVO INFLATION." THE CUSTOMER IS NOT ABLE TO CONFIRM IF THE SECOND CATHER WAS WAS INSERTED INTO THE SAME INSERTION SITE. PATIENT'S CURRENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18950398 ↗
• MalfunctionOct 14, 2022Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  THE REPORT STATES THAT "THE BALLOON INFLATED ASYMMETRICALLY DURING USE. THEREFORE, THE CATHETER WAS REPLACED WITH ANOTHER KIT OF THE SAME LOT TO COMPLETE THE PROCEDURE. THE USER FLUSHED THE CATHETER BUT DID NOT PERFORM THE INFLATION TEST BEFORE USE". ADDITIONAL INFORMATION RECEIVED ON 26 SEP 2022, STATES THAT "THE 2ND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO MEDICAL INTERVENTION WAS NECESSARY". NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15609722 ↗
• MalfunctionOct 13, 2022Inflation Problem; Inflation Problem

  THE REPORT STATES THAT "THE BALLOON DID NOT INFLATE PROPERLY DURING USE. THEREFORE, THE CATHETER WAS REPLACED WITH ANOTHER KIT OF THE SAME LOT TO COMPLETE THE PROCEDURE. THE USER FLUSHED THE CATHETER BUT DID NOT PERFORM THE INFLATION TEST BEFORE USE." ADDITIONAL INFORMATION STATES THAT THE SECONDARY CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15600639 ↗
• MalfunctionJul 6, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE MD WAS PERFORMING THE PROCEDURE ACCORDING TO THE IFU. THE MD FOUND THAT THE BALLOON WOULD NOT INFLATE DUE TO A CATHETER DEFECT. AS A RESULT, THE MD JUDGED IT AS A DEFECTIVE PRODUCT AND ANOTHER CATHETER WAS USED AT THE SAME INSERTION SITE. THERE WAS NO REPORT OF DELAY IN THERAPY. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12120588 ↗

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