ARROW IPN000082Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801902002266), received between Mar 7, 2019 and Mar 25, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2025Material Deformation; Material Deformation

  IT WAS RPEORTED "BALLOON IS TILTED TO ONE SIDE AND UNABLE TO DETECT PRESSURE." THE DEVICE WAS REMOVED AND NOT REPLACED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". PLEASE SEE ASSOCAITED MDR#: 3010532612-2025-00234.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21687518 ↗
• MalfunctionMar 25, 2025Material Deformation; Material Deformation

  IT WAS RPEORTED "BALLOON IS TILTED TO ONE SIDE AND UNABLE TO DETECT PRESSURE." THE DEVICE WAS REMOVED AND NOT REPLACED. 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 21687476 ↗
• MalfunctionOct 3, 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 AND COMPLETED THE PROCEDURE. NO HARM TO THE PATIENT WAS REPORTED". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17863552 ↗
• MalfunctionOct 19, 2022Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  IT WAS REPORTED THAT THE "BALLOON INFLATED ASYMMETRICALLY". THEREFORE, ANOTHER KIT WAS USED INSTEAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO CUSTOMER AS NO PATIENT DETAILS WAS PROVIDED AT TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 15631121 ↗
• MalfunctionMar 10, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT "THE BALLOON BURSTS DURING USAGE ON A PATIENT. THE 4-FRENCH CATHETER WAS INFLATED AND DEFLATED SEVERAL TIMES DURING THE APPLICATION (ANGIOGRAPHY); THE CUSTOMER DESCRIBED IT AS "PERMANENT USE"." IT WAS REPORTED THAT THERE WAS NO HARM OR INJURY TO THE PATIENT AND THE PATIENT CURRENT CONDITION IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9813585 ↗
• MalfunctionApr 15, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE EVENT OCCURRED PRIOR TO USE ON A PATIENT (PRE-TESTING). IT WAS REPORTED THAT THE BALLOON RUPTURED OR PERFORATED BEFORE TESTING. AS A RESULT, A NEW BERMAN ANGIOGRAPHIC CATHETER WAS USED. THERE WAS NO REPORT OF PATIENT INJURY OR CONSEQUENCE. ADDITIONAL INFORMATION. IT WAS REPORTED THAT THE RUPTURED OCCURRED PRIOR TO USE. THE SAMPLE WAS RECEIVED FOR INVESTIGATION. A PRELIMINARY INVESTIGATION WAS DONE, DRIED BLOOD WAS NOTED WITHIN THE INJECTION EXTENSION LINE OF THE RETURNED SAMPLE. THE COMPLAINT WAS REASSESSED AND DEEMED REPORTABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8514706 ↗
• MalfunctionMar 7, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE CATHETER WAS INJECTED AT 600PSI AND THE BALLOON LUMEN SYRINGE BACKED UP AND THEY HEARD A POP (ASSUMED IT WAS BALLOON WHICH SHOULD NOT BE AFFECTED WHEN INJECTING DYE) SO THE DEVICE WAS IMMEDIATELY REMOVED. THERE WAS NO REPORT OF PATIENT COMPLICATION OR SERIOUS INJURY AND DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8401241 ↗

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