ARROW IPN038102Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801902136718), received between Sep 9, 2022 and Jun 29, 2023 — classified as 2 deaths, 8 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• DeathJun 29, 2023Difficult to Remove; Difficult to Remove

  THE REPORT STATES, "AN IAB WAS PLACED PRE OP, PATIENT WENT TO OR FOR TRANSPLANT, AND PATIENT RETURNED FROM OR TO ICU WITHOUT INCIDENT. THE SHEATH REMOVAL TEAM REMOVED THE IAB. AFTER IAB WAS DISCONTINUED, 'CLOTS SHOWERED THE PATIENT AND LACTATE LEVELS ROSE'. PATIENT ULTIMATELY EXPIRED WITHIN 24H OF IAB DISCONTINUATION". ADDITIONAL INFORMATION RECEIVED STATED THAT THE TRANSPLANT THE PATIENT UNDERWENT WAS A HEART TRANSPLANT IN WHICH THEY RECEIVED ANTICOAGULATION FOR IN THE OPERATING ROOM. THE IAB WAS INSERTED FEMORALLY, THE CUSTOMER DID NOT INDICATE LEFT OR RIGHT. THE REMOVAL OF THE IAB WAS PLANNED AS IABP THERAPY WAS DISCONTINUED. THE LACTATE LEVEL WAS "STABLE" PRIOR TO IAB REMOVAL. HOWEVER, AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR MULTIPLE INQUIRIES REGARDING THE CAUSE OF DEATH, PAST MEDICAL HISTORY, PATIENT DEMOGRAPHICS, LENGTH OF IABP THERAPY, IF THE PUMP WAS PAUSED AT ANY TIME AND FOR HOW LONG, IF THERE WAS DIFFICULTY REMOVING THE IAB, THE FULL ANATOMIC DISTRIBUTION OF THE "SHOWER OF EMBOLI", LAST MEASURED PLATELET COUNT, IF THE PATIENT WAS SCREENED FOR CONSUMPTIVE COAGULOPATHY, IF AN AUTOPSY WAS PERFORMED AND IF RESULTS WERE AVAILABLE TO US, AND IF THE PHYSI

  Patient problems: Insufficient Information; Thromboembolism

  MAUDE report 17228070 ↗
• DeathJun 29, 2023Difficult to Remove; Difficult to Remove

  THE REPORT STATES, "AN IAB WAS PLACED PRE OP, PATIENT WENT TO OR FOR TRANSPLANT, AND PATIENT RETURNED FROM OR TO ICU WITHOUT INCIDENT. THE SHEATH REMOVAL TEAM REMOVED THE IAB. AFTER IAB WAS DISCONTINUED, 'CLOTS SHOWERED THE PATIENT AND LACTATE LEVELS ROSE'. PATIENT ULTIMATELY EXPIRED WITHIN 24H OF IAB DISCONTINUATION". ADDITIONAL INFORMATION RECEIVED STATED THAT THE TRANSPLANT THE PATIENT UNDERWENT WAS A HEART TRANSPLANT IN WHICH THEY RECEIVED ANTICOAGULATION FOR IN THE OPERATING ROOM. THE IAB WAS INSERTED FEMORALLY, THE CUSTOMER DID NOT INDICATE LEFT OR RIGHT. THE REMOVAL OF THE IAB WAS PLANNED AS IABP THERAPY WAS DISCONTINUED. THE LACTATE LEVEL WAS "STABLE" PRIOR TO IAB REMOVAL. HOWEVER, AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR MULTIPLE INQUIRIES REGARDING THE CAUSE OF DEATH, PAST MEDICAL HISTORY, PATIENT DEMOGRAPHICS, LENGTH OF IABP THERAPY, IF THE PUMP WAS PAUSED AT ANY TIME AND FOR HOW LONG, IF THERE WAS DIFFICULTY REMOVING THE IAB, THE FULL ANATOMIC DISTRIBUTION OF THE "SHOWER OF EMBOLI", LAST MEASURED PLATELET COUNT, IF THE PATIENT WAS SCREENED FOR CONSUMPTIVE COAGULOPATHY, IF AN AUTOPSY WAS PERFORMED AND IF RESULTS WERE AVAILABLE TO US, AND IF THE PHYSI

  Patient problems: Insufficient Information; Thromboembolism

  MAUDE report 17227701 ↗
• MalfunctionJun 26, 2023Break; Break

  IT WAS REPORTED THAT DURING CARDIAC SURGERY IN THE OR, AFTER THE IAB WAS INSERTED, STAFF THEN CONNECTED THE PRESSURE TUBING TO THE CENTRAL LUMEN AND THE LUER-LOCK ON THE PRESSURE TUBING CRACKED AND BROKE OFF. AS A RESULT, 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 17197791 ↗
• MalfunctionJun 9, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  THE REPORT STATES THAT WHILE IN USE ON A PATIENT, THE "BALLOON FAILED TO FULLY UNWRAP". AS A RESULT, THE IAB WAS REMOVED. A 2ND IAB WAS NOT INSERTED AS THE "PATIENT WAS IMPROVING". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100442 ↗
• MalfunctionMay 30, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE IAB WAS INSERTED WITHOUT ISSUE, HOWEVER WHEN THE USER ATTEMPTED TO INFLATE THE BALLOON, IT WAS NOTED THAT THE BALLOON WAS PERFORATED.

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

  MAUDE report 17023216 ↗
• MalfunctionMay 26, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE "BALLOON DIDN'T INFLATE ALL THE WAY INITIALLY". AS A RESULT, A NEW CATHETER WAS INSERTED. 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 17012412 ↗
• MalfunctionMar 20, 2023Inflation Problem; Inflation Problem

  REPORTED AS "VISUALIZED IAB NOT FULLY UNWRAPPING UNDER FLUOROSCOPY." IT WAS REPORTED THAT THE ISSUE WAS NOTED IMMEDIATELY AFTER INSERTION, VISUALIZED UNDER FLUOROSCOPY; INCREASED DIFFICULTIES ON ARRIVAL TO ICU. MDS INITIALLY OPTING TO LEAVE IAB IN PLACE DESPITE RECOMMENDATION TO EXCHANGE CATHETER. PRIMARY ICU RN TO FOLLOW UP WITH MDS DUE TO CONTINUED DIFFICULTY WITH IAB IN ICU. ON CALL WITH RN AT APPROXIMATELY 1402, "POSSIBLE HELIUM LOSS 3, SUBCODE 2" THREE TIMES FOLLOWED BY "DEFLATION TIMING MAY BE LATE" AND TWO ADDITIONAL "POSSIBLE HELIUM LOSS 3, SUBCODE 2". IAB WAS ULTIMATELY REMOVED AND ANOTHER ONE INSERTED AT THE SAME INSERTION SITE. PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16573079 ↗
• MalfunctionOct 29, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED "IAB CATHETER PREPARATION NOT SUFFICIENT FOR SUCCESSFUL ENTRY INTO THE SHEATH". THE REPORTED DEFECT WAS STATED INITIALLY TO BE DETECTED PRIOR TO USE. ADDITIONAL INFORMATION RECEIVED ON 28 OCT 2022 CONFIRMED THE EVENT HAPPENED DURING USE WHEN THE CATHETER WAS BEING ADVANCED IN THE SHEATH. THE CATHETER WAS REPLACED, SAME INSERTION SITE WAS USED. NO PATIENT HARM, INJURY, OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15696558 ↗
• MalfunctionSep 9, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "AFTER INSERTION, INCOMPLETE INFLATION OF THE BALLOON IS NOTED ON ECHOCARDIOGRAPHY". ADDITIONAL INFORMATION RECEIVED STATED THAT AN ADDITIONAL CATHETER WAS USED. UNKNOWN IF SECOND CATHETER WAS INSERTED AT THE SAME SITE AT TIME OF REPORT. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396774 ↗
• MalfunctionSep 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "RUPTURED IAB". ADDITIONAL INFORMATION RECEIVED STATED THAT "THE IAB RUPTURED ON (B)(6) AND WAS REMOVED WITHIN APPROPRIATE TIMEFRAME AND NO ISSUES WITH REMOVAL AND SUBSEQUENT INSERTION OF A NEW IAB. THERE WERE HELIUM ALARMS NOTED, ARTIFICIAL HEART TEAM CALLED TO BEDSIDE AND BLOOD NOTED IN THE DRIVELINE. THE PATIENT REMAINED STABLE DURING ENTIRE PROCEDURE". SECOND CATHETER INSERTED AT THE SAME SITE. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396662 ↗