ARROW IPN000073Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801902004468), received between Mar 27, 2020 and Mar 25, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT CARDIAC TAMPONADE OCCURRED DURING THE PROCEDURE WITH A BALLOON CATHETER DUE TO THE PRESSURE APPLIED WITH THE CATHETER INTO THE CORONARY SINUS. AN URGENT CARDIAC SURGERY WAS REQUIRED. ACCORDING TO FOLLOW-UP INFORMATION RECEIVED, THE PATIENT IS STILL IN THE HOSPITAL, BUT IMPROVING.

  Patient problems: Cardiac Tamponade

  MAUDE report 13903036 ↗
• MalfunctionMar 27, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE BALLOON TIP OF THE CATHETER IS TWISTED. THE DEVICE IS PLACED AT THE JUGULARIS AND USED FOR BALLOONING OF THE VESSEL FOR DOGS (VETERINARY USE). WHEN THE BALLOON TIP IS TWISTED IT IS VERY DIFFICULT TO MOVE THE CATHETER IN THE VESSEL CAUSING A DELAY RESULTING IN AN EXTENSION OF THE ANESTHESIA." THERE WAS NO REPORT OF HARM OR COMPLICATIONS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9889591 ↗

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