ARROW IPN000072Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00801902002877), received between Oct 23, 2019 and Oct 16, 2025 — classified as 1 death, 32 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (7 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT "DURING THE PROCEDURE THE MD FOUND CATHETER CANNOT BE INSERTED ALONG THE GUIDE WIRE. SO THE MD OPEND UP THE NEW KIT TO FINISH THE PROCEDURE". 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 23310056 ↗
• MalfunctionOct 6, 2025Connection Problem; Connection Problem

  IT WAS REPORTED "WE HAD A BALLOON THAT RUPTURED ON CONTACT WITH THE PATIENT'S STENT DURING A CASE. NO INJURIES OR HARM TO THE PATIENT HAS BEEN REPORTED". ADDITIONAL INFORMATION STATES "THE PATIENT REMAINED STABLE AND NO FURTHER INTERVENTION WAS REQUIRED".

  Patient problems: Insufficient Information

  MAUDE report 23228074 ↗
• MalfunctionSep 3, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "BALLOON WOULD NOT INFLATE". ADDITIONAL INFORMATION STATES THAT THE CATHETER WAS REPLACED TO CONTINUE THERAPY. 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 22955373 ↗
• MalfunctionAug 4, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED " INITIALLY WE TRIED TO DO THE RIGHT HEART CATHETERIZATION FROM THE RIGHT MEDIAN VEIN BUT WE COULD NOT ADVANCE THESWAN'S BALLOON AND THEN I TRIED TO PULL THE BALLOON OUT BUT IT GOT STUCK AND ALTHOUGH IT WAS NOT INFLATED MULTIPLEATTEMPT TO REMOVE THE BALLOON WAS NOT SUCCESSFUL THEN THE BALLOON WAS PULLED OUT TO SLOWLY AND WHEN I GOT THEBALLOON OUT THERE WAS SOME TISSUE STUCK TO THE BALLOON FOR NO KNOWN REASON AS THE BALLOON WAS NEVER INFLATEDINSIDE THE VEIN AND IT IS NOT CLEAR IF THIS TISSUES IS PART OF THE VEIN OR PART OF THE SUBCUTANEOUS TISSUE. IMMEDIATELYAFTER REMOVING THE SWAN-GANZ CATHETER THE AREA WAS COMPRESSED WITH A PRESSURE DRESSING". ADDITIONAL INFORMATION STATES THAT "WAS ABLE TO COMPLETE VIA FEMORAL VEIN". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22699139 ↗
• MalfunctionJul 11, 2025Inflation Problem; Failure to Deflate; Inflation Problem; Failure to Deflate

  IT WAS REPORTED THAT " BALLOON INFLATION WAS DIFFICULT AND DEFLATION DIFFICULT / IMPOSSIBLE. THE CATHETER WAS CHANGED". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENTS CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED COMPLAINT MDR 3010532612-2025-00419.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480269 ↗
• MalfunctionJun 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "THE BALLOON GOT RUPTURED DURING USE. THE USER REPLACED THE CATHETER WITH A NEW ONE (PN# AI-07126) AND THE PROCEDURE WAS COMPLETED. NO INJURY TO THE PATIENT WAS REPORTED. THE USER PERFORMED A FLUSHING TEST BEFORE USE". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345333 ↗
• MalfunctionJan 2, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED "IT WAS REPORTED THAT THE LUMEN WAS FLUSHED WITHOUT PROBLEM. HOWEVER, WHEN THE USER INSERTED A GUIDEWIRE THROUGH THE CATHETER, IT STOPPED ON THE WAY AND COULD NOT BE ADVANCED FURTHER. THE USER REPLACED THE CATHETER WITH ANOTHER ONE, BUT THE SAME ISSUE OCCURRED. NO INJURY TO THE PATIENT WAS REPORTED". A THIRD CATHETER WAS INSERTED TO CONTINUE THERAPY. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN". 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. PLEASE SEE ASSOCIATED MDR# 3010532612-2025-00009.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057053 ↗
• MalfunctionJan 2, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED "IT WAS REPORTED THAT THE LUMEN WAS FLUSHED WITHOUT PROBLEM. HOWEVER, WHEN THE USER INSERTED A GUIDEWIRE THROUGH THE CATHETER, IT STOPPED ON THE WAY AND COULD NOT BE ADVANCED FURTHER. THE USER REPLACED THE CATHETER WITH ANOTHER ONE, BUT THE SAME ISSUE OCCURRED. NO INJURY TO THE PATIENT WAS REPORTED". A THIRD CATHETER WAS INSERTED TO CONTINUE THERAPY. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN". 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 21056835 ↗
• MalfunctionDec 27, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT " THE BALLOON INFLATED BUT DID NOT DEFLATE DURING PROCEDURE". ADDITIONAL INFORMATION STATED THAT THE BALLOON WAS REMOVED. THE USER REPORTED "I TRIED AGAIN TO DEFLATE IT ON THE TABLE, WITHOUT SUCCESS. THEN, A FEW SECONDS LATER, IT DEFLATED ON ITS OWN. THEN IT WAS IMPOSSIBLE TO RE-INFLATE IT". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE, NO CLINICAL CONSEQUENCES". IT IS UNKNOWN IF ANOTHER DEVICE WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025844 ↗
• MalfunctionNov 14, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED "I HAVE A BALLOON WEDGE CATHETER THAT RUPTURED DURING USE". WHEN ASKED WHAT INTERVENTION WAS CHOSEN THE CUSTOMER STATES "NO INTERVENTION REQUIRED". THE PATIENT'S CURRENT STATUS IS REPORTED AS "UNKNOWN". THE CUSTOMER REPORTED THAT THERE WAS NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20686145 ↗
• MalfunctionJun 28, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED "THE BALLOON DID NOT INFLATE ENOUGH DURING USE. THEREFORE, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW KIT , IN SERTED AT THE SAME INSERTION SITE TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OCCURRED.THE INFLATION TEST BEFORE USE HAD BEEN DONE WITHOUT PROBLEM." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19635246 ↗
• MalfunctionMay 23, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED " IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE ENOUGH AFTER THE CATHETER WAS INSERTED INTO THE PATIENT. THEREFORE, IT WAS REMOVED AND REPLACED WITH A NEW KIT. THE BALLOON INFLATED NORMALLY DURING THE INFLATION TEST BEFORE USE. NO INJURY TO THE PATIENT OCCURRED". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19381114 ↗
• MalfunctionMay 7, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED "BALLOON PUNCTURE, FAILURE". ADDITIONAL INFORMATION STATUS THAT THIS ISSUE HAPPENED PRIOR TO USE. NO PATIENT INVOLVEMENT. ANOTHER CATHETER WAS USED TO BEGIN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19261610 ↗
• MalfunctionApr 25, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT, "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".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19187804 ↗
• MalfunctionApr 9, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING US ON A PATIENT, THE "BALLOON BURST". 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070793 ↗
• MalfunctionJan 16, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT "THE MD WAS UNABLE TO PASS THE WIRE THROUGH THE CATHETER. THERE WAS NO HARM TO THE PATIENT". ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PATIENT CONSEQUENCES, NO MEDICAL INTERVENTION REQUIRED, THE CURRENT STATUS OF THE PATIENT IS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 18519489 ↗
• DeathJan 4, 2024Malposition of Device; Malposition of Device

  RECEIVED VIA A MEDWATCH REPORT, SUBMITTED BY THE RISK MANAGER AT THE HEALTH CARE FACILITY, THE REPORT STATES "WITH ULTRASOUND GUIDANCE, WE OBTAINED ACCESS TO THE RIGHT COMMON FEMORAL ARTERY AND VEIN WITH MICRO PUNCTURE NEEDLE AND THEN ADVANCED A 6 FR SHEATH OVER A WIRE IN EACH USING THE SELDINGER APPROACH. ARROW CATHETER WAS ADVANCED IN THE PULMONARY ARTERY AND USED TO OBTAIN HEMODYNAMICS MEASUREMENTS. DURING CATHETER ADVANCEMENT OVER A J-WIRE TO OBTAIN ACCURATE PULMONARY WEDGE PRESSURE, PATIENT DECOMPENSATED AND WENT INTO RESPIRATORY ARREST WITH HEMOPTYSIS AND ASPIRATION. THIS COULD HAVE BEEN SECONDARY TO POSSIBLE CATHETER INDUCED PULMONARY ARTERY RUPTURE AND PULMONARY HEMORRHAGE. DESPITE ALL EMERGENT CARDIOPULMONARY RESUSCITATION EFFORTS PATIENT EXPIRED". THE MEDWATCH REPORT STATES THAT THE PATIENT WAS AN "84 [YEAR OLD] FEMALE WITH HISTORY OF HTN, HLP, HFPEF, MODERATE VALVULAR DISEASE AND COPD/OSA ADMITTED FOR CHEST PAIN AND SOB. PRIOR HISTORY OF CARDIAC CATHETERIZATION IN 2021, WITH MILD DISEASE AND ECHO IN 2021 SHOWING AS AND AI. REPEAT ECHO IN 6/23 SHOWED PRESERVED EF AND MODERATE AS. SHE WAS SCHEDULED FOR OP PROCEDURE BUT HER SYMPTOMS GOT WORSE WARRANTING HER TO COME TO THE E

  Patient problems: Insufficient Information

  MAUDE report 18444330 ↗
• MalfunctionJan 3, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, MD FOUND THAT CATHETERS DO NOT ENTER ALONG GUIDE WIRE. SO MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18439722 ↗
• MalfunctionNov 21, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, MD FOUND THAT DURING THE PROCEDURE BALLOON RUPTURE. SO MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 18182214 ↗
• MalfunctionNov 8, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE BALLOON INFLATED NORMALLY DURING THE INFLATION TEST BEFORE USE. HOWEVER, IT DID NOT INFLATE ENOUGH AFTER THE CATHETER WAS INSERTED INTO THE PATIENT. THEREFORE, IT WAS REMOVED AND REPLACED WITH A NEW KIT OF THE SAME LOT, INSERTED AT THE SAME INSERTION SITE TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OCCURRED." THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18096909 ↗
• MalfunctionOct 12, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT "THE USER INSERTED THE CATHETER FROM THE GROIN AND ADVANCED IT TO AROUND THE RENAL ARTERY. HOWEVER, THE CATHETER COULD NOT BE ADVANCED FURTHER. THEREFORE, THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE PROCEDURE WITHOUT PROBLEM. NO INJURY TO THE PATIENT OCCURRED". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17922504 ↗
• MalfunctionAug 10, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT "THE GUIDE WIRE GETS STUCK AT THE TIP OF THE CATHETER. IT HAPPENED WITH TWO CATHETERS. THIRD ONE WORKED PROPERLY". NO PATIENT HARM, INJURY, OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS "FINE". ADDITIONAL INFORMATION RECEIVED STATED THAT THE TWO CATHETERS WERE USED ON THE SAME PATIENT, PART AND LOT NUMBER WERE THE SAME FOR BOTH DEVICES. NO ISSUES WITH THE THIRD CATHETER. ASSOCIATED TO MDR 3010532612-2022-00310.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15197903 ↗
• MalfunctionAug 10, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT "THE GUIDE WIRE GETS STUCK AT THE TIP OF THE CATHETER. IT HAPPENED WITH TWO CATHETERS. THIRD ONE WORKED PROPERLY". NO PATIENT HARM, INJURY, OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS "FINE". ADDITIONAL INFORMATION RECEIVED STATED THAT THE TWO CATHETERS WERE USED ON THE SAME PATIENT, PART AND LOT NUMBER WERE THE SAME FOR BOTH DEVICES. NO ISSUES WITH THE THIRD CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15197821 ↗
• MalfunctionJul 1, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT "THE BALLOON AT THE END OF THE CATHETER WAS BROKEN, SO MD COULD NOT USE IT ON THE PATIENT". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14896496 ↗
• MalfunctionJul 14, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT "GUIDE WIRE CANNOT BE INSERTED INTO THE CATHETER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12165423 ↗

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