ARROW IPN000085Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801902002297), received between Oct 18, 2022 and Aug 6, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE AFTER THE CATHETER WAS INSERTED INTO THE PATIENT. THEREFORE, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE. THE REMOVED BALLOON DID NOT INFLATE OUTSIDE THE BODY. AFTER THAT, THE PROCEDURE WAS COMPLETED". THE LOCATION OF THE SECOND CATHETER IS REPORTED FROM THE CUSTOMER AS "UNKNOWN". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730152 ↗
• MalfunctionJun 28, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED, "IT WAS REPORTED THAT AIR WAS FOUND DURING ANGIOGRAPHY AFTER BALLOON INFLATION. THE USER TRIED TO DEFLATE THE BALLOON, BUT THE BALLOON WAS UNABLE TO BE DEFLATED. HE APPLIED NEGATIVE PRESSURE TO THE CONTRAST LUMEN AND REMOVED THE CATHETER. THE CATHETER WAS REPLACED WITH A NEW KIT AND COMPLETED THE PROCEDURE. NO HARM TO THE PATIENT WAS REPORTED." THE SECOND CATHETER WAS INSERTED INTO THE SAME INSERTION SITE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19637023 ↗
• MalfunctionMay 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "THE BALLOON LEAK WAS CONFIRMED DURING USE. THEREFORE, THE USER REPLACED THE CATHETER WITH A NEW ONE. THERE WERE NO PROBLEMS DURING THE INFLATION TEST BEFORE USE." NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247299 ↗
• MalfunctionApr 30, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED "IT WAS REPORTED THAT "IT WAS REPORTED THAT THE USER WAS UNABLE TO INSERT THE CATHETER INTO THE PATIENT DURING INSERTION. THEREFORE, A NEW CATHETER WAS REPLACED." ADDITIONAL INFORMTION REPORTS ,"THE USER WAS UNABLE TO INSERT THE CATHETER INTO THE SHEATH DURING INSERTION". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN" AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 19216372 ↗
• MalfunctionApr 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED " BALLOON LEAK WAS CONFIRMED DURING USE. THEREFORE, THE USER REPLACED THE CATHETER WITH A NEW ONE". NO PATIENT INJURY OR HARM REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212681 ↗
• MalfunctionOct 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT "THE BALLOON GOT RUPTURED DURING THE PROCEDURE. THEREFORE, THE USER REPLACED THE CATHETER WITH A NEW ONE. NO PATIENT INJURY WAS REPORTED". THE 2ND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17890040 ↗
• MalfunctionSep 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE DEVICE "WHILE INJECTING (700PSI) THE CLEAN PORTION END OF THE TUBING ON THE PROXIMAL END RUPTURED". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 17769467 ↗
• MalfunctionOct 18, 2022Material Deformation; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15627146 ↗

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