ARROW IPN000074Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801902002884), received between Jul 31, 2018 and May 21, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT " BALLOON INFLATION WAS DIFFICULT AND DEFLATION DIFFICULT / IMPOSSIBLE. THE CATHETER WAS CHANGED, THERE WAS NO CONSEQUENCES FOR THE PATIENT. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22063129 ↗
• MalfunctionNov 21, 2023Break; Break

  IT WAS REPORTED THAT DURING USE "THE BALLOON POPPED AS THE STAFF WERE INFLATING IT". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 18182044 ↗
• MalfunctionSep 1, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A LEAK WAS FOUND FROM THE CATHETER DURING USE ON A PATIENT. AS A RESULT, THE CATHETER WAS REPLACED WITH A NEW KIT. THERE WAS NO REPORT OF PATIENT COMPLICATION, SERIOUS INJURY OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12406112 ↗
• MalfunctionJul 7, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED BY KENNETH GAINES SUPPLY COOR CARADIC CATH LAB AT TEXAS CHILDRENS HOSPITAL THAT BALLOON BURST WHILE IN USE. THREE FOLLOW UP ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT CONDITION AND IF THE DEVICE IS AVAILABLE FOR RETURN BUT THEY WERE UNSUCCESSFUL. IF WE RECEIVED ADDITIONAL INFORMATION, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131078 ↗
• MalfunctionJul 7, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED BY KENNETH GAINES SUPPLY COOR CARADIC CATH LAB AT TEXAS CHILDRENS HOSPITAL. IT WAS REPORTED THAT BALLOON BURST WHILE IN USE. THREE FOLLOW UP ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT CONDITION AND IF THE DEVICE IS AVAILABLE FOR RETURN BUT THEY WERE UNSUCCESSFUL. IF WE RECEIVED ADDITIONAL INFORMATION, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129837 ↗
• MalfunctionJul 7, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED BY (B)(6) LAB AT (B)(6) HOSPITAL. IT WAS REPORTED THAT BALLOON BURST WHILE IN USE. THREE FOLLOW UP ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT CONDITION AND IF THE DEVICE IS AVAILABLE FOR RETURN BUT THEY WERE UNSUCCESSFUL. IF WE RECEIVED ADDITIONAL INFORMATION, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129813 ↗
• MalfunctionMay 6, 2021Unable to Obtain Readings; Unable to Obtain Readings

  THIS COMPLAINT WAS RECEIVED VIA ADVERSE EVENT NOTIFICATION FROM INARI MEDICAL. IT WAS REPORTED THAT DURING USE ON A PATIENT, THERE WAS AN ISSUE WITH THE TRANSDUCER AND THEREFORE NO PRE PRESSURES WERE RECORDED. UNRELATED TO THE REPORTED EVENT (UNABLE TO GET A PRESSURE READING), LATER ON IN THE CASE THE PATIENT SUFFERED A RUPTURED PAPILLARY MUSCLE AND TRICUSPID VALVE INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787177 ↗
• InjuryJan 25, 2021Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING CARDIO MEMS IMPLANT PROCEDURE, THE CATHETER WAS INSERTED AND WAS NOTED BY THE STAFF THAT THE PATIENT HAD A LARGE RIGHT ATRIUM (CONFIRMED VIA X-RAY). THE LARGE RIGHT ATRIUM HAD THE CATHETER PROLAPSE ON ITSELF, WHICH MADE IT MORE DIFFICULT TO ADVANCE THE CATHETER. HOWEVER, THE CATHETER WAS ABLE TO BE GUIDED INTO THE RIGHT ATRIUM, RIGHT VENTRICLE, AND PULMONARY ARTERY. EVENTUALLY, THE CATHETER WAS GUIDED INTO THE LEFT BRANCH OF THE PULMONARY ARTERY BUT COULDN'T ADVANCE AS THE CATHETER WOULD NOT ADVANCE FAR ENOUGH DOWN THE SELECTED VESSEL. DIFFERENT APPROACHES WERE MADE BUT WERE UNSUCCESSFUL. THE STAFF DETERMINED THAT PERFORATION OCCURRED SOMEWHERE ON THE RIGHT SIDE OF THE HEART. THE IMPLANT WAS ABANDONED DUE TO THE COMPLICATIONS.

  Patient problems: No Information

  MAUDE report 11222847 ↗
• MalfunctionMar 4, 2019Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE SPRING WIRE GUIDE WAS UNABLE TO ADVANCE THRU THE CATHETER. AS A RESULT, ANOTHER CATHETER WAS USED. THERE WAS A REPORT OF DELAY IN THERAPY. THERE WAS NO REPORT OF PATIENT COMPLICATION OR SERIOUS INJURY AND DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8386835 ↗
• MalfunctionJul 31, 2018Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR HAD ATTEMPTED TO USE AN ARROW BALLOON WEDGE PRESSURE CATHETER ON A PATIENT. HE DID INSERT IT INTO THE PATIENT, IT INFLATED PARTIALLY, AND HOWEVER, IT WOULD NOT DEFLATE. NO COMPLICATIONS TO THE PATIENT WERE INCURRED. IT POSSIBLY RUPTURED UPON REMOVAL BECAUSE IT WAS DEFLATED WHEN IT CAME OUT. WHEN HE RE-ATTEMPTED TO RE-INFLATE OUTSIDE OF THE PATIENT, IT INFLATED PARTIALLY BUT NOT FULLY. " THERE WAS NO REPORTED PATIENT DEATH, SERIOUS INJURY OR COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7736143 ↗

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