ARROW IPN923527Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10801902206746), received between Jun 10, 2022 and Apr 4, 2024 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (6 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2024

  ELDERLY MALE WITH HISTORY OF CHRONIC SYSTOLIC HEART FAILURE. PROCEDURE: RIGHT HEART CATHETERIZATION. THE BALLOON OF THE SWAN WAS STUCK INFLATED THEREFORE RECORDING INCORRECT PRESSURES. BALLOON WOULD NOT DEFLATE. NO KNOWN HARM TO PATIENT- ANOTHER ONE USED WITHOUT ISSUES. MANUFACTURER RESPONSE FOR CATHETER, FLOW DIRECTED, ARROW (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19040084 ↗
• MalfunctionJul 19, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT WHILE IN USE WITH A PATIENT, THE USER WAS UNABLE TO INJECT THROUGH THE CATHETER, "FELT LIKE THERE WAS AN OCCLUSION". AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED AND USED WITHOUT ISSUE. NO PATIENT HARM OR INJURY. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17354253 ↗
• MalfunctionJul 10, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, MD FOUND THAT THE BALLOON DID NOT SWELL DURING THE PROCEDURE. SO MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE." NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17291573 ↗
• MalfunctionJul 10, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, MD FOUND THAT THE BALLOON DID NOT SWELL DURING THE PROCEDURE. SO MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE." NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17291432 ↗
• MalfunctionJun 29, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT "THE BALLOON GOT RUPTURED DURING THE INFLATION TEST BEFORE USE. THEREFORE, A NEW KIT WAS OPENED INSTEAD". HOWEVER, UPON RETURN OF THE SAMPLE, DRIED BLOOD WAS NOTED ON THE EXTERIOR AND INTERIOR OF THE DEVICE INDICATING THAT IT WAS USED ON A PATIENT. BE UPDATED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17232181 ↗
• MalfunctionMay 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DOCTOR FOUND THAT THE BALLOON HAD RUPTURED. AS A RESULT, THE CATHETER WAS REMOVED AND NEW CATHETER WAS INSERTED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE." 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17021407 ↗
• MalfunctionMay 18, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE USER FELT DIFFICULTY WHEN INSERTING THE GUIDEWIRE THROUGH THE CATHETER. THE CATHETER WAS ABLE TO BE PLACED, HOWEVER THE CONTRAST MEDIUM WAS UNABLE TO BE INJECTED PROPERLY. AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16952667 ↗
• MalfunctionMar 23, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, MD FOUND INFLATION FAILURE. SO MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE." THERE WAS NO DELAY IN THERAPY. THE PATIENT STATUS IS REPORTED AS "FINE". PER THE CUSTOMER, IT IS UNKNOWN IF THE BALLOON WAS TESTED PRIOR TO INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600491 ↗
• MalfunctionFeb 21, 2023Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT, " BALLOON DEFLATED SPONTANEOUSLY AFTER INSERTION, A SECOND DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED". ADDITIONAL INFORMATION STATES THE 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16408761 ↗
• MalfunctionFeb 16, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  "IT WAS REPORTED THAT THE USER WAS UNABLE TO INSERT A GUIDEWIRE THROUGH THE CATHETER DURING USE. THEREFORE, THE CATHETER WAS REPLACED WITH A NEW KIT OF THE SAME CATALOG AND LOT NUMBER, INSERTED AT THE SAME INSERTION SITE TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT WAS REPORTED." PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16389794 ↗
• MalfunctionJan 17, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, [PHYSICIAN] FOUND BALLOON RUPTURED, SO [PHYSICIAN] OPENED UP A NEW KIT TO FINISH THE PROCEDURE". ADDITIONAL INFORMATION STATES THAT THE SECOND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO REPORT OF PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION NEEDED. THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183876 ↗
• MalfunctionJan 5, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BALLOON SUFFERED A TEAR DURING INSERTION. THEREFORE, A NEW CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO REPORT OF PATIENT HARM OR INJURY. PATIENT STATUS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16104528 ↗
• MalfunctionNov 2, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "IMAGING WAS INSUFFICIENT DURING ANGIOGRAPHY. WHEN THE USER REMOVED THE CATHETER, A KINK WAS FOUND IN FRONT OF THE BALLOON. THEREFORE, [THE USER] OPENED ANOTHER KIT OF THE SAME LOT, INSERTED AT THE SAME INSERTION SITE, BY WHICH COMPLETED THE PROCEDURE WITHOUT PROBLEM. IT WAS UNKNOWN WHEN THE CATHETER KINKED (HAD IT KINKED FROM THE BEGINNING OR GOT KINKED DURING THE PROCEDURE)". NO REPORT OF PATIENT HARM OR INJURY. PATIENT STATUS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15716749 ↗
• MalfunctionOct 27, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT "THE CATHETER WAS USED WITHOUT PROBLEM AT FIRST, BUT THE BALLOON GRADUALLY DEFLATED. THEREFORE, IT WAS REMOVED AND REPLACED WITH ANOTHER KIT OF THE SAME PRODUCT, INSERTED AT THE SAME SITE TO COMPLETE THE PROCEDURE". THE CURRENT PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15685250 ↗
• MalfunctionOct 25, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE BALLOON DID NOT INFLATE ENOUGH DURING USE. THEREFORE, IT WAS REMOVED AND REPLACED WITH ANOTHER KIT OF THE SAME PRODUCT, INSERTED AT THE SAME SITE TO COMPLETE THE PROCEDURE WITHOUT PROBLEM. THE USER FLUSHED THE FIRST SAMPLE BUT DID NOT PERFORM THE INFLATION TEST BEFORE USE". THE PATIENT HEALTH CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15669052 ↗
• MalfunctionOct 18, 2022Material Twisted/Bent; Material Twisted/Bent

  THE REPORT STATES THAT "THE USER INSERTED THE CATHETER AT THE GROIN. HOWEVER, PROBABLY BECAUSE THE ILIAC ARTERY WAS SEVERELY CALCIFIED AND BENT, THE CATHETER KINKED. THE USER REMOVED IT AND CONFIRMED THE TIP KINKED. THEN THE USER INSERTED ANOTHER CATHETER OF THE SAME LOT AT THE SAME INSERTION SITE, BY WHICH COMPLETED THE PROCEDURE WITHOUT PROBLEM. NO HARM TO THE PATIENT WAS REPORTED. THE USER FLUSHED THE CATHETER, BUT DID NOT PERFORM THE INFLATION TEST BEFORE USE". NO REPORT OF DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15627171 ↗
• MalfunctionOct 18, 2022Inflation Problem; Inflation Problem

  COMPLAINT FROM MEDWATCH REPORT. THE REPORT STATES THAT DURING A "RIGHT HEART CATHETERIZATION, WHEN THE ARROW BALLOON WEDGE PRESSURE CATHETER WAS USED, ONLY PART OF THE BALLOON WOULD INFLATE, THEN IT WOULD NOT DEFLATE PROPERLY. NO KNOWN HARM TO PATIENT BUT DID DELAY CASE". ADDITIONAL INFORMATION STATES THAT A NEW CATHETER WAS INSERTED WITHOUT ISSUE. NO REPORT OF PATIENT HARM OR INJURY. ASSOCIATED MDR 3010532612-2022-00420.

  Patient problems: Insufficient Information

  MAUDE report 15624913 ↗
• MalfunctionOct 18, 2022Failure to Deflate; Failure to Deflate

  COMPLAINT FROM MEDWATCH REPORT. THE REPORT STATES THAT DURING A "RIGHT HEART CATHETERIZATION, WHEN THE ARROW- BALLOON WEDGE PRESSURE CATHETER WAS USED, ONLY PART OF THE BALLOON WOULD INFLATE, THEN IT WOULD NOT DEFLATE PROPERLY. NO KNOWN HARM TO PATIENT BUT DID DELAY CASE". ADDITIONAL INFORMATION STATES THAT A NEW CATHETER WAS INSERTED WITHOUT ISSUE. NO REPORT OF PATIENT HARM OR INJURY. ASSOCIATED MDR 3010532612-2022-00427.

  Patient problems: Insufficient Information

  MAUDE report 15624892 ↗
• MalfunctionOct 13, 2022Burst Container or Vessel; Burst Container or Vessel

  THE REPORT STATES THAT "DURING THE PROCEDURE ACCORDING TO IFU, BALLOON AT THE END OF THE CATHETER WAS BROKEN, SO [THE CLINICIAN] COULD NOT USE IT ON THE PATIENT" ADDITIONAL INFORMATION STATES THAT THE CATHETER RUPTURED DURING USE ON THE PATIENT. AN ADDITIONAL CATHETER WAS INSERTED. NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15600756 ↗
• MalfunctionOct 13, 2022Material Deformation; Material Deformation

  THE REPORT STATES THAT "DURING THE PROCEDURE ACCORDING TO IFU, BALLOON AT THE END OF THE CATHETER WAS BROKEN, SO [THE CLINICIAN] COULD NOT USE IT ON THE PATIENT" ADDITIONAL INFORMATION STATES THAT THE CATHETER RUPTURED DURING USE ON THE PATIENT. AN ADDITIONAL CATHETER WAS INSERTED. NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15600642 ↗
• MalfunctionOct 10, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT "THE GUIDEWIRE (EXTRA STIFF GW, 0.035INCH, COOK MEDICAL JAPAN) DID NOT COME OUT FROM THE TIP OF THE CATHETER DURING USE. THEREFORE, A NEW KIT WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15572658 ↗
• MalfunctionJun 10, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON COULD NOT BE INFLATED AFTER INSERTION OF THE CATHETER. THE USER REMOVED THE CATHETER AND ATTEMPTED TO INFLATE THE BALLOON OUTSIDE OF THE PATIENT BODY, BUT IT COULD NOT BE INFLATED. AS A RESULT, A NEW KIT WAS USED INSTEAD. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY, OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14658785 ↗

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