ARROW IPN000083Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801902002273), received between Jun 18, 2020 and Jul 2, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED "BALLOON RUPTURE UPON USE". ADDITIONAL INFORMATION STATES "THERE WAS NO HUMAN PATIENT INVOLVED, THIS EVENT OCCURED DURING AN ANGIO ON A DOG. A NEW PRODUCT WAS OPENED AND USED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386260 ↗
• MalfunctionSep 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED "IT WAS REPORTED THAT THE EXTENSION LINE NEAR THE HUB GOT RUPTURED DURING USE. A NEW KIT WAS USED INSTEAD BUT SAME PROBLEM OCCURRED. THEREFORE, A NEW KIT WAS USED INSTEAD AGAIN. THE SAME PROBLEM OCCURRED TWICE IN ONE PATIENT." PLEASE SEE ASSOCIATED MDR# 3010532612-2024-00732.

  Patient problems: Insufficient Information

  MAUDE report 20150802 ↗
• MalfunctionSep 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED "IT WAS REPORTED THAT THE EXTENSION LINE NEAR THE HUB GOT RUPTURED DURING USE. A NEW KIT WAS USED INSTEAD BUT SAME PROBLEM OCCURRED. THEREFORE, A NEW KIT WAS USED INSTEAD AGAIN. THE SAME PROBLEM OCCURRED TWICE IN ONE PATIENT." ASSOCIATED MDR# 3010532612-2024-00729.

  Patient problems: Insufficient Information

  MAUDE report 20150726 ↗
• MalfunctionAug 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT " IT WAS REPORTED THAT AIR KEPT LEAKING FROM THE HUB SIDE DURING USE. THEREFORE, A NEW KIT WAS USED INSTEAD". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 20016288 ↗
• MalfunctionAug 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "AIR KEPT LEAKING FROM THE HUB SIDE DURING USE. THEREFORE, A NEW KIT (OTHER COMPANIES' PRODUCT) WAS USED INSTEAD."THE REPORTED DEFECT WAS DETECTED PRIOR TO USE (IN A CLINICAL SETTING). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 19992448 ↗
• MalfunctionAug 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "AIR KEPT LEAKING FROM THE HUB SIDE DURING USE. THEREFORE, A NEW KIT (OTHER COMPANIES' PRODUCT) WAS USED INSTEAD". NO PATIENT HARM OR INJURY REPORTED.AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 19992327 ↗
• MalfunctionApr 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED " THE FRONT END OF THE CATHETER CANNONT BE USED". ADDITIONAL INFORMATION STATES THAT THE CATHETER COULD NOT BE SEEN UNDER ANGIOGRAPHY. TO CONTINUE/COMPLETE THERAPY, ANOTHER CATHETER WAS INSERTED USING THE SAME INSERTION SITE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19187833 ↗
• MalfunctionFeb 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED "THE BALLOON CAN'T BE INFLATED, BECAUSE IT'S [LEAKING] ON THE [HUB] OF [THE CONNECTOR]". ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT'S CURRENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18677063 ↗
• MalfunctionDec 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "IT WAS REPORTED THAT THE BALLOON GOT RUPTURED AND AIR LEAKED DURING THE INFLATION TEST BEFORE USE. THEREFORE, A NEW KIT WAS USED INSTEAD". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18265970 ↗
• MalfunctionOct 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT, "WHEN THE CONTRAST AGENT WAS BEING INJECTED, THE CATHETER GOT TORN. THE USER REMOVED THE CATHETER AND REPLACED WITH A NEW ONE, INSERTED AT THE SAME INSERTION SITE, AND FINISHED THE PROCEDURE. NO HARM TO THE PATIENT WAS REPORTED". THE AMOUNT OF CONTRAST INJECTED AS 14ML, THE INJECTION SPEED WAS 6ML/SECOND. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994660 ↗
• MalfunctionSep 8, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, "BALLOON LEAKAGE ISSUE". THE PATIENT STATUS IS REPORTED AS "FINE". 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 17713572 ↗
• MalfunctionSep 8, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, "BALLOON LEAKAGE ISSUE". THE PATIENT STATUS IS REPORTED AS "FINE". 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 17713474 ↗
• MalfunctionSep 6, 2023Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ANGIOGRAM WAS PERFORMED, "INJECTION WAS ATTEMPTED AND THE CATHETER TIP RUPTURED AND CONTRAST CAME OUT OF CAT HETER ONTO THE CATH FIELD AND FLOOR. WE TRIED WITH A SECOND CATHETER AND THE SAME THING HAPPENED". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". SEE ASSOCIATED MDR #3010532612-2023-00496.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690305 ↗
• MalfunctionSep 6, 2023Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ANGIOGRAM WAS PERFORMED, "INJECTION WAS ATTEMPTED AND THE CATHETER TIP RUPTURED AND CONTRAST CAME OUT OF CAT HETER ONTO THE CATH FIELD AND FLOOR. WE TRIED WITH A SECOND CATHETER AND THE SAME THING HAPPENED". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPROTED AS "FINE". SEE ASSOCIATED MDR #3010532612-2023-00497.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690260 ↗
• MalfunctionAug 31, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT "DURING A PROCEDURE, THE PHYSICIAN PERFORMED RIGHT VENTRICULAR ANGIOGRAPHY FOR THE PATIENT THROUGH THE ALLEGED UNIT BY USING A POWER INJECTOR. THE INJECTION PRESSURE SETTING WAS LOWER THAN THE MAXIMUM INJECTION PRESSURE INDICATED ON IFU. A CRACK WAS OBSERVED AT THE CATHETER AFTER INJECTION WHICH CAUSED FLUID LEAKAGE". ADDITIONAL INFORMATION RECEIVED STATES THAT THE SETTINGS WERE VOLUME-10ML; FLOW-12ML/SEC; RISE TIME-0.3 SECS; PRESSURE LIMIT- 500PSI, AND THE LEAK WAS LOCATED AT THE PROXIMAL END OF THE CATHETER (OUTSIDE OF THE PATIENT). AS A RESULT, THE OPERATOR REMOVED THE CATHETER AND STOPPED PERFORMING FURTHER ANGIOGRAPHY. NO MEDICAL INTERVENTION REQUIRED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17666065 ↗
• MalfunctionAug 22, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "THE CONTRAST AGENT WAS FOUND LEAKING FROM THE PART OF THE CATHETER NEAR THE USER'S HAND DURING USE. AS THE LEAK DID NOT STOP THEREAFTER, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE, INSERTED AT THE SAME INSERTION SITE TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT WAS REPORTED. THE USER WAS UNABLE TO FIND AT WHICH PART OF THE CATHETER THE LEAK OCCURRED." THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597378 ↗
• MalfunctionJun 16, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "THE CATHETER GOT TORN DURING THE PROCEDURE. THE CATHETER WAS REPLACED WITH A NEW ONE, INSERTED AT THE SAME INSERTION SITE, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE THIRD CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT WAS REPORTED." ASSOCIATED MDR 3010532612-2023-00327. ADDITIONAL INFORMATION RECEIVED STATED "BOTH CATHETERS GOT TORN AT THE BASE, WHERE THE BALLOON LUMEN AND THE INJECTION LUMEN MEET, AND THE CONTRAST MEDIA LEAKED. THE CONTRAST MEDIA USED: OMNIPAQUE 350. INJECTION RATE: 1. 8CC/SEC, 12CC MEASURED MAXIMUM INJECTION PRESSURE: 496PSI. 2. 6CC/SEC 12CC MEASURED MAXIMUM INJECTION PRESSURE: 538PSI.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148514 ↗
• MalfunctionJun 16, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "THE CATHETER GOT TORN DURING THE PROCEDURE. THE CATHETER WAS REPLACED WITH A NEW ONE, INSERTED AT THE SAME INSERTION SITE, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE THIRD CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT WAS REPORTED." ASSOCIATED MDR 3010532612-2023-00326. ADDITIONAL INFORMATION RECEIVED STATED "BOTH CATHETERS GOT TORN AT THE BASE, WHERE THE BALLOON LUMEN AND THE INJECTION LUMEN MEET, AND THE CONTRAST MEDIA LEAKED. THE CONTRAST MEDIA USED: OMNIPAQUE 350. INJECTION RATE: 1. 8CC/SEC, 12CC MEASURED MAXIMUM INJECTION PRESSURE: 496PSI. 2. 6CC/SEC 12CC MEASURED MAXIMUM INJECTION PRESSURE: 538PSI."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148509 ↗
• MalfunctionOct 14, 2022Break; Break

  THE REPORT STATES THAT "WHEN CONTRAST AGENT WAS INJECTED, THE EXTENSION LINE BROKE. THEREFORE, THE CATHETER WAS REPLACED WITH A NEW ONE. NO HARM TO THE PATIENT WAS REPORTED." FURTHER INFORMATION STATES THAT THE ADDITIONAL CATHETER WAS INSERTED AT THE SAME INSERTION SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611100 ↗
• MalfunctionOct 20, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT PROCUREMENT NOTICED A HOLE IN THE EXTERNAL PACKAGING ON ONE OF THE PRODUCT DURING STOCKING.

  Patient problems: No Patient Involvement

  MAUDE report 10705333 ↗
• MalfunctionJun 18, 2020Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT WHEN THE DOCTOR INSERTED THE BALLOON, IT WAS NOTED THAT THE BALLOON WOULD NOT INFLATE PROPERLY. THE CATHETER WAS PULLED OUT FROM THE PATIENT'S BODY AND INFLATED, AND THE BALLOON BURST. THEREFORE, THE DOCTOR JUDGED THE PRODUCT TO BE DEFECTIVE. AS A RESULT, THE DOCTOR USED A NEW CATHETER TO COMPLETE TREATMENT. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10168209 ↗

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