ARROW IPN000253Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801902010742), received between Dec 20, 2018 and Aug 14, 2023 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE "IAB TUBING CONNECTION WAS FOUND TO BE LEAKING AFTER MOVING PATIENT TO OR TABLE AND SUBSEQUENTLY LOST PRESSURE WAVEFORM. IT WAS TIGHTENED BEST AS POSSIBLE AND TAPED WITH A TEGADERM. THE REMEDY WAS TO REMOVE THE TUBING WITH THE STOPCOCK ALL TOGETHER AND DIRECT WET TO WET CONNECTION. WE FLUSHED THE LINE AND RE-ZEROED, AND THE PRESSURE WAVEFORM RETURNED. THIS WAS AFTER THE PATIENT WAS IN SICU POST-OP. IAB WAS LATER REMOVED." NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541064 ↗
• InjuryAug 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT IN THE OR DURING A CABG SURGERY, "THE DEVICE WAS LEAKING AND THE OPERATORS ATTEMPTED TO TIGHTEN THE CONNECTION AND THE RESULT WAS A COMPLETE BREAK ON THE HUB OF THE TUBING. REMEDY WAS PRESS THE CONNECTION TOGETHER AS TIGHT AS POSSIBLE AND THEY TAPED IT TOGETHER TO GET THEM THROUGH THE CASE. THE PATIENT LOST ABOUT 300CC'S OF BLOOD AS THE CONNECTION WAS UNDER THE STERILE DRAPE AND THE LEAK WAS NOT DETECTED UNTIL THEY HEARD 'DRIPPING' ONTO THE FLOOR FROM UNDER THE STERILE DRAPE. THE PATIENT HAD TO BE TRANSFUSED AS A RESULT.".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17540894 ↗
• MalfunctionJul 19, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT AN IAB WAS INSERTED WITHOUT DIFFICULTY. AFTER DISCONTINUATION OF IABP THERAPY AND THE IAB WAS READY FOR REMOVAL, "THE DOCTOR COULDN'T PULL NEGATIVE ON THE BALLOON FOR REMOVAL. HE TRIED PULLING THE BALLOON BACK INTO THE CATHETER AND IT DIDN'T GO EASILY. HE ENDED UP PULLING BOTH THE SHEATH AND THE BALLOON OUT BUT WHEN IT WAS OUT THE BALLOON WAS SHEARED OFF. HE HAD TO HOLD PRESSURE FOR ABOUT 45 MINUTES AND THEN AFTER GOT AN ULTRASOUND TO MAKE SURE NOTHING WAS LEFT IN THE PATIENT. EVERYTHING LOOKED OK ON THE ULTRASOUND AND THE PATIENT IS DOING 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 17354961 ↗
• InjuryJul 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT AFTER INSERTION OF THE IAB IN THE LEFT AXILLARY SITE, THE BALLOON RUPTURED AS BLOOD WAS NOTED IN THE HELIUM TUBING. AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED AT THE FEMORAL SITE. NO PATIENT HARM OR INJURY AS "PATIENT TOLERATED PROCEDURE WITHOUT ANY COMPLICATIONS."

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17293335 ↗
• MalfunctionJul 5, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AFTER INSERTION OF THE IAB, THE PUMP ALARMED FOR "RESTRICTION" AND INFLATION OF THE BALLOON WAS UNABLE TO BE VISUALIZED UNDER FLUOROSCOPY. AN "ANGLE NEAR THE TOP OF THE BALLOON" WAS ALSO NOTED. MANUAL INFLATION AND DEFLATION WAS ABLE TO BE ACHIEVED HOWEVER, THE DETERMINATION WAS MADE TO SWITCH OUT THE IAB. THE IAB WAS REMOVED AND A 2ND IAB 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 17259953 ↗
• MalfunctionMay 18, 2023Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  THE REPORT STATES THAT "AN IABP THAT WAS OPENED FOR CLINICAL USE THE OTHER DAY WAS FOUND TO HAVE A DEFECT: THE YELLOW HOUSING SHEATH THAT IS SUPPOSED TO HOLD THE TIP OF THE BALLOON IN PLACE WAS ACTUALLY LOCATED ON THE WRONG END OF THE BALLOON, CLOSER TO THE HELIUM CONNECTION. AS A RESULT, WE WERE UNABLE TO USE THIS BALLOON". THE REPORT STATES THAT THIS OCCURRED PRIOR TO USE IN THE CLINICAL SETTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16957119 ↗
• MalfunctionDec 12, 2019Break; Inflation Problem; Leak/Splash; Break; Inflation Problem; Leak/Splash

  IT WAS REPORTED THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED INTO THE PATIENT'S RIGHT FEMORAL ARTERY THROUGH THE SIDEPORT SHEATH WITHOUT DIFFICULTY. WHEN THE IAB WAS INFLATED IT WAS NOTED THAT THE IAB WOULD NOT FULLY INFLATE. AS A RESULT, THE IAB WAS REMOVED AND A SECOND IAB WAS USED ON THE PATIENT. AFTER THE IAB WAS REMOVED, THE TECH CONNECTED THE IAB TO ANOTHER INTRA-AORTIC BALLOON PUMP (IABP) AND HEARD AIR COMING OUT. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9460752 ↗
• MalfunctionDec 4, 2019Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED BY THE RN THAT THERE IS A BLOODY, FROTHY LOOKING CONDENSATE IN THE HELIUM DRIVE LINE TUBING, THE NURSE STATED THAT HE HAS NOT HAD ANY ALARMS. THE CLINICAL SUPPORT SPECIALIST EXPLAINED TO THE RN THAT THE INTRA-AORTIC BALLOON (IAB) HAD TO BE REMOVED AS SOON AS POSSIBLE. THE RN REPORTED THAT THE MESSAGE WOULD BE RELATED TO THE MD. THERE WAS NO REPORT OF PATIENT INJURY OR CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9410840 ↗
• MalfunctionDec 3, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT AFTER THE PLACEMENT OF THE 30CC INTRA-AORTIC BALLOON CATHETER (IABC), THE USER FOUND THAT THE PATIENT'S BUILD IS TOO BIG FOR THE CATHETER AND TRIED TO REMOVE IT. HOWEVER, IT WAS NOTED THAT THE CATHETER GOT STUCK IN THE SHEATH AND THE DOCTOR HAD TO REMOVE THE IAB TOGETHER WITH THE SHEATH. A 40CC CATHETER WAS INSERTED IN THE PATIENT. THERE WAS NO REPORT OF DELAY IN THERAPY. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9405478 ↗
• MalfunctionDec 20, 2018Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE EVENT OCCURRED DURING INCOMING INSPECTION. WHEN THE IAB KIT ARRIVED AT THE CATH LAB INVENTORY FROM THE WAREHOUSE, IT WAS NOTED THAT THE SEAL WAS BROKEN, AND THE PACKAGING WAS OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8185532 ↗
• MalfunctionDec 20, 2018Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE EVENT OCCURRED DURING INCOMING INSPECTION. WHEN THE IAB KIT ARRIVED AT THE CATH LAB INVENTORY FROM THE WAREHOUSE, IT WAS NOTED THAT THE SEAL WAS BROKEN, AND THE PACKAGING WAS OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8184978 ↗