ARROW IPN917235Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 10801902180787), received between Jan 31, 2023 and Aug 14, 2023 — classified as 69 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (36 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 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2023Fluid/Blood Leak; 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 WAS SET AT 400 PSI, WHICH IS LOWER THAN THE MAXIMUM INJECTION PRESSURE INDICATED ON IFU. THE FIRST RV-GRAM WAS PERFORMED SMOOTHLY, BUT WHEN THE PHYSICIAN WAS ATTEMPTING TO DO ANOTHER INJECTION, HE NOTICED THAT THERE WAS A LEAKAGE OF FLUID FROM THE PROXIMAL PART OF THE CATHETER THAT WAS OUTSIDE THE PATIENT'S BODY. THE CATHETER WAS DISCONNECTED FROM THE PATIENT AND A CRACK WAS OBSERVED AT THE CATHETER WHICH MIGHT CAUSE THE FLUID LEAKAGE MENTIONED. AS THE RESULT WAS CONFIRMED BY THE FIRST RV ANGIOGRAM, SO THE PROCEDURE ENDED FOLLOWING THE INCIDENT." NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 17541123 ↗
• MalfunctionAug 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT "THERE WAS NO PROBLEM DURING A FLUSHING AND AN INFLATION TEST BEFORE USE. HOWEVER, THE CATHETER GOT TORN NEAR THE HUB DURING USE, IN SPITE THAT THE MAXIMUM INJECTION PRESSURE WAS KEPT LESS THAN THAT SPECIFIED IN IFU." AS A RESULT, THE CATHETER WAS REMOVED AND 2ND CATHETER WAS INSERTED AT THE SAME INSERTION SITE, HOWEVER THE SAME ISSUE OCCURRED. "THE USER REMOVED THE CATHETER AND FINISHED THE PROCEDURE. NO HARM TO THE PATIENT WAS REPORTED." THE PATIENT STATUS IS REPORTED AS "FINE". SEE ASSOCIATED MDR #3010532612-2023-00436.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17514960 ↗
• MalfunctionAug 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT "THERE WAS NO PROBLEM DURING A FLUSHING AND AN INFLATION TEST BEFORE USE. HOWEVER, THE CATHETER GOT TORN NEAR THE HUB DURING USE, IN SPITE THAT THE MAXIMUM INJECTION PRESSURE WAS KEPT LESS THAN THAT SPECIFIED IN IFU." AS A RESULT, THE CATHETER WAS REMOVED AND 2ND CATHETER WAS INSERTED AT THE SAME INSERTION SITE, HOWEVER THE SAME ISSUE OCCURRED. "THE USER REMOVED THE CATHETER AND FINISHED THE PROCEDURE. NO HARM TO THE PATIENT WAS REPORTED." THE PATIENT STATUS IS REPORTED AS "FINE". SEE ASSOCIATED MDR #3010532612-2023-00435.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17514905 ↗
• MalfunctionAug 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CATHETER "RUPTURED DURING A CASE" DISTAL TO THE CONNECTION HUB. AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED, HOWEVER THE SAME ISSUE OCCURRED. A 3RD CATHETER WAS THEN INSERTED AND AGAIN THE SAME ISSUE OCCURRED. ALL 3 CATHETERS WERE INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "STABLE". SEE ASSOCIATED MDRS #3010532612-2023-00450 AND #3010532612-2023-00451.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17443793 ↗
• MalfunctionJul 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CATHETER "RUPTURED DURING A CASE" DISTAL TO THE CONNECTION HUB. AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED, HOWEVER THE SAME ISSUE OCCURRED. A 3RD CATHETER WAS THEN INSERTED AND AGAIN THE SAME ISSUE OCCURRED. ALL 3 CATHETERS WERE INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "STABLE". SEE ASSOCIATED MDRS #3010532612-2023-00449 AND #3010532612-2023-00451.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17425178 ↗
• MalfunctionJul 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CATHETER "RUPTURED DURING A CASE". AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED, HOWEVER THE SAME ISSUE OCCURRED. A 3RD CATHETER WAS THEN INSERTED AND AGAIN THE SAME ISSUE OCCURRED. 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. SEE ASSOCIATED MDRS #3010532612-2023-00449 AND #3010532612-2023-00450.

  Patient problems: Insufficient Information

  MAUDE report 17425052 ↗
• MalfunctionJul 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT "THE FIRST INJECTION OF CONTRAST AGENT WAS DONE WITHOUT PROBLEM. HOWEVER, THE CATHETER GOT TORN WHEN THE CONTRAST AGENT WAS INJECTED FOR THE SECOND TIME. THE USER COMPLETED THE PROCEDURE. NO HEALTH CONSEQUENCE TO THE PATIENT WAS REPORTED". THE CATHETER WAS TORN NEAR THE HUB. MECHANICAL INJECTION WAS USED TO COMPLETE THE PROCEDURE. THE CONTRAST AGENT USED WAS LOHEXOL 350 AT AN INJECTION RATE OF 8CC/SEC AND AN INJECTION PRESSURE OF 590 PSI WHICH IS GREATER THAN SPECIFIED IN THE IFU. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259774 ↗
• MalfunctionJun 30, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED VIA A MEDWATCH REPORT THAT "THERE WAS A SMALL HOLE IN THE SIDE OF THE CATHETER THAT WAS OUTSIDE THE BODY. CONTRAST WAS INJECTED THROUGH THE CATHETER USING A POWER INJECTOR. POWER INJECTOR SETTINGS WERE CONFIRMED APPROPRIATE FOR THE CATHETER. NO HARM TO THE PATIENT, AS THE DEFECTIVE PART OF THE CATHETER DID NOT ENTER THE BODY". 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. MEDWATCH REPORT NUMBER NOT PROVIDED. UF/IMPORTER REPORT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238882 ↗
• MalfunctionJun 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE CATHETER GOT TORN DURING THE PROCEDURE. THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS USED, INSERTED AT THE SAME INSERTION SITE, BUT THE SAME ISSUE OCCURRED. AS A RESULT, A 3RD CATHETER WAS INSERTED AT THE SAME INSERTION SITE AND WAS USED SUCCESSFULLY. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". ACCORDING TO THE USER, THE INJECTION PRESSURE WAS PROBABLY 600PSI. SEE ASSOCIATED MDR#3010532612-2023-00336.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17185379 ↗
• MalfunctionJun 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE CATHETER GOT TORN DURING THE PROCEDURE. THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS USED, INSERTED AT THE SAME INSERTION SITE, BUT THE SAME ISSUE OCCURRED. AS A RESULT, A 3RD CATHETER WAS INSERTED AT THE SAME INSERTION SITE AND WAS USED SUCCESSFULLY. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". ACCORDING TO THE USER, THE INJECTION PRESSURE WAS PROBABLY 600PSI. SEE ASSOCIATED MDR #3010532612-2023-00337.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17185251 ↗
• MalfunctionJun 19, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "THE CATHETER GOT TORN DURING THE PROCEDURE. THEREFORE, IT WAS REPLACED WITH A NEW ONE, INSERTED AT THE SAME INSERTION SITE TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17152691 ↗
• MalfunctionJun 15, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "THE CATHETER GOT TORN DURING THE PROCEDURE. THEREFORE, IT WAS REPLACED WITH A NEW ONE, INSERTED AT THE SAME IN SERTION SITE TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17135075 ↗
• MalfunctionJun 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE "BALLOON GOT RUPTURED WHEN IT WAS INFLATED WITH CARBON DIOXIDE GAS DURING THE PROCEDURE. THEREFORE, THE USER REPLACED THE CATHETER WITH A NEW ONE, INSERTED AT THE SAME INSERTION SITE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED". THE PATIENT STATUS IS REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17052803 ↗
• MalfunctionJun 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING POWER INJECTION WHILE IN USE ON A PATIENT WITH A PSI OF 500, THE CATHETER RUPTURED. AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED. IT IS UNCLEAR WHAT SITE THE 2ND CATHETER WAS INSERTED AT. 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 17052625 ↗
• MalfunctionMay 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT WITH THE INJECTION PRESSURE AT 500PSI, THE CATHETER RUPTURED. AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17003174 ↗
• MalfunctionMay 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING USE ON A PATIENT WITH INJECTION PRESSURE AT 500PSI, THE CATHETER RUPTURED. AS A RESULT, THE CATHETER WAS REMOVED A 2ND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. WHEN THE RUPTURED OCCURRED, THE CARDIOLOGIST WAS STRUCK IN THE EYE WITH CONTRAST. ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO HARM OR INJURY TO THE CARDIOLOGIST. THE CONTRAST AGENT WAS NOT MIXED WITH ANY PATIENT BLOOD OR BODILY FLUID, PROTECTIVE EYEWEAR WAS BEING WORN AT THE TIME OF THE EVENT, AND THE CARDIOLOGIST DID NOT REQUIRE TO BE SEEN BY OCCUPATIONAL HEALTH OR NEED FURTHER MEDICAL EVALUATION OR TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17003051 ↗
• MalfunctionMay 19, 2023Burst Container or Vessel; Burst Container or Vessel

  THE REPORT STATES THAT THERE WAS "A 5FR BERMAN ANGIO THAT BROKE DURING THE POWER INJECTION (PROXIMAL PORTION OUTSIDE THE PATIENT)". THE MAX PRESSURE USED WAS 1200 PSI. 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 REPORTED AS "GOOD, NO CLINICAL COMPLICATION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16963806 ↗
• MalfunctionMay 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT "THE CATHETER GOT TORN DURING THE PROCEDURE". AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16961807 ↗
• MalfunctionMay 18, 2023Material Rupture; Material Rupture

  THE REPORT STATES "5FR X 80CM BERMAN FAIL. IT RUPTURED NEAR THE HUB OF THE CATHETER". ADDITIONAL INFORMATION RECEIVED STATES THAT THE EVENT OCCURRED WHILE IN USE ON A PATIENT DURING AN ANGIOGRAM. THE INJECTOR SETTINGS WERE RATE 12ML/S FOR 16ML, 500PSI, AND .5 RISE. AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED AT THE SAME INSERTIONS SITE. NO PATIENT HARM OR INJURY. THE PATIENT'S STATUS IS REPORTED AS "UNCHANGED FROM THE USE OF THE CATHETER".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16954803 ↗
• MalfunctionMay 18, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE INJECTING CONTRAST MEDIUM THROUGH THE CATHETER, THE CATHETER LEAKED. AS A RESULT, THE CATHETER WAS REMOVED AND 2ND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. HOWEVER, THE SAME ISSUE OCCURRED WITH THE 2ND CATHETER, THEREFORE THE USER PERFORMED AN ANGIOGRAPHY USING A SHEATH TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION STATES THAT THE EXACT INJECTION PRESSURE USED EACH TIME WAS UNKNOWN BUT IT WAS "LESS THAN THE MAXIMUM INJECTION PRESSURE STATED IN THE IFU". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16953506 ↗
• MalfunctionMay 18, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE INJECTING CONTRAST MEDIUM THROUGH THE CATHETER, THE CATHETER LEAKED. AS A RESULT, THE CATHETER WAS REMOVED AND 2ND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. HOWEVER, THE SAME ISSUE OCCURRED WITH THE 2ND CATHETER, THEREFORE THE USER PERFORMED AN ANGIOGRAPHY USING A SHEATH TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION STATES THAT THE EXACT INJECTION PRESSURE USED EACH TIME WAS UNKNOWN BUT IT WAS "LESS THAN THE MAXIMUM INJECTION PRESSURE STATED IN THE IFU". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16953483 ↗
• MalfunctionMay 11, 2023Material Rupture; Material Rupture

  THE REPORT STATES THAT WHILE IN USE ON A PATIENT, THE BALLOON BURST DURING INJECTION AT 1100PSI. AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED. THE 2ND CATHETER BALLOON ALSO BURST DURING INJECTION. THERE WAS NO PATIENT HARM OR INJURY, THE PATIENT WAS DISCHARGED HOME. SEE ASSOCIATED MDR 3010532612-2023-00253.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16914967 ↗
• MalfunctionMay 11, 2023Material Rupture; Material Rupture

  THE REPORT STATES THAT WHILE IN USE ON A PATIENT, THE BALLOON BURST DURING INJECTION AT 1100PSI. AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED. THE 2ND CATHETER BALLOON ALSO BURST DURING INJECTION. THERE WAS NO PATIENT HARM OR INJURY, THE PATIENT WAS DISCHARGED HOME. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. SEE ASSOCIATED MDR 3010532612-2023-00254.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16913753 ↗
• MalfunctionMay 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE CATHETER BURST.

  Patient problems: Insufficient Information

  MAUDE report 16911566 ↗
• MalfunctionMay 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE CATHETER BURST. THE PSI WAS 500. 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 16870986 ↗

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