MEGA 7.5Fr. 40cc IAB (with APA) 0684-00-0295-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10607567107981), received between Jun 11, 2021 and Mar 13, 2026 — classified as 2 deaths, 17 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (13 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 23, 2023Class IIOpen, Classified

   During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.

   Z-2219-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Leak/Splash; Material Rupture

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24596860 ↗
• MalfunctionFeb 27, 2026Pacing Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24466305 ↗
• MalfunctionFeb 5, 2026Material Rupture

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24266513 ↗
• MalfunctionJan 28, 2026Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT INTRA AORTIC BALLOON (IAB) WAS SMOOTHLY INSERTED AND ALARM TRIGGERED LEAK IN IAB CIRCUIT. BLOOD WAS FOUND IN THE TUBING. CATHETER WAS PULL OUT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24197441 ↗
• MalfunctionOct 17, 2025Fluid/Blood Leak; Leak/Splash; Increase in Pressure; Material Rupture; Obstruction of Flow; Material Deformation; Material Twisted/Bent; Fluid/Blood Leak; Leak/Splash; Increase in Pressure; Material Rupture; Obstruction of Flow; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT A BALLOON CATHETER INTRA-AORTIC BALLOON (IAB) RUPTURE OCCURRED DURING OVERNIGHT USE OF THE IAB CATHETER. THE PATIENT WAS AMBULATORY WITH LEFT AXILLARY INSERTION. PRIOR TO THE RUPTURE, THE SYSTEM EXPERIENCED REPEATED HIGH PRESSURE AND KINK ALARMS, VOLUME REDUCTIONS, AND CENTRAL LUMEN ISSUES INCLUDING DAMPENING AND CLOTTING. THE PUMP CONSOLE WAS EVENTUALLY EXCHANGED, AND THE CATHETER WAS REMOVED WITHOUT COMPLICATIONS.

  Patient problems: Cardiomyopathy; Heart Failure/Congestive Heart Failure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23320616 ↗
• MalfunctionJun 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN INTRA-AORTIC BALLOON CATHETER WAS INSERTED LEFT AXILLARY 7.5FR, FOUND BLOOD IN HELIUM LINE, NO KNOWN COMPLICATIONS, PATIENT WAS AMBULATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201821 ↗
• MalfunctionMay 23, 2025Material Perforation; Material Perforation

  IT WAS REPORTED THAT DURING INTRA AORTIC BALLOON (IAB) THERAPY CUSTOMER IDENTIFIED PERFORATION IN BALLOON. NO PATIENT INJURY OR HARM WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076220 ↗
• MalfunctionMay 12, 2025Device Alarm System; Difficult to Advance; Gas/Air Leak; Device Alarm System; Difficult to Advance; Gas/Air Leak

  IT WAS REPORTED BY CUSTOMER THAT WHILE PERFORMING FEMORAL ARTERY PUNCTURE DURING INTRA AORTIC BALLOON (IAB) THERAPY ON A PATIENT USING A BALLOON CATHETER, THE PUNCTURE PROCESS WAS NOT SMOOTH AND AIR LEAKAGE OCCURRED. AFTER THE PUNCTURE FAILED, THE DOCTOR IMMEDIATELY REPLACED THE DISPOSABLE PUNCTURE NEEDLE AND SUCCESSFULLY INSERTED THE BALLOON. THERE WERE NO CASUALTIES AND NO MACHINE MALFUNCTIONS IN THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001009 ↗
• MalfunctionDec 19, 2023Leak/Splash; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357580 ↗
• MalfunctionFeb 10, 2023Leak/Splash; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16354948 ↗
• MalfunctionJan 19, 2023Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16207294 ↗
• MalfunctionDec 20, 2022Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED THAT DURING INSERTION OF THE INTRA-AORTIC BALLOON(IAB), THE GUIDEWIRE WAS BENT AND IT WASN'T POSSIBLE TO INSERT. ANOTHER GUIDEWIRE WAS USED TO START INSERTION OF THE IAB. THERE WAS NO REPORTED INJURY OR ADVERSE EVENT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16015407 ↗
• MalfunctionAug 22, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER APPROXIMATELY 19 DAYS OF INTRA-AORTIC BALLOON (IAB) THERAPY, BLOOD WAS SEEN IN THE TUBING WHILE AMBULATING THE PATIENT. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. THE TUBING WAS CLAMPED AND THE CONSOLE WAS TURNED OFF. NO ALARMS WERE NOTED. THE IAB WAS REMOVED AND THE PHYSICIAN WAS NOTIFIED. A NEW IAB WAS INSERTED VIA THE RIGHT FEMORAL ARTERY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266605 ↗
• MalfunctionJul 14, 2022Leak/Splash; Migration; Leak/Splash; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, AFTER APPROXIMATELY 16 DAYS OF INTRA-AORTIC BALLOON (IAB) THERAPY, THE IAB WAS NOTED TO BE HIGH WITH MINIMAL ADVANCEMENT. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. ON (B)(6) 2022 23:10, THE CONSOLE GENERATED A HIGH PRESSURE ALARM AND BLOOD WAS NOTED IN THE EXTRACORPOREAL TUBING. THE LINE WAS CLAMPED AND NO BLOOD WAS IN THE CONSOLE. ON 1(B)(6) 2022 00:45, THE IAB WAS REMOVED AND AT 10:45 A NEW IAB WAS INSERTED. ON (B)(6) 2022, AN IMPELLA DEVICE WAS INSERTED. LATER THAT DAY AT 21:18, THE SECOND IAB WAS REMOVED AS IT WAS NO LONGER NEEDED. ON (B)(6) 2022, THE PATIENT WAS REPORTED TO BE STABLE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15019557 ↗
• DeathJun 22, 2022Leak/Splash; Difficult to Remove; Leak/Splash; Difficult to Remove

  IT WAS REPORTED THAT AFTER APPROXIMATELY EIGHT DAYS OF INTRA-AORTIC BALLOON (IAB) THERAPY, BLOOD SPECS WERE NOTED IN THE EXTRACORPOREAL TUBING. THE CONSOLE WAS TURNED OFF. THE IAB WAS REMOVED APPROXIMATELY ONE HOUR LATER. THE CUSTOMER HAD DIFFICULTY REMOVING THE IAB. CARDIOLOGY ADVISED TO CONTINUE REMOVING GENTLY UNTIL THE IAB CAME OUT, REMOVING THE SHEATH AND IAB AT SAME TIME. FEM STOP WAS APPLIED AND THE PATIENT LOST PULSES. THE PATIENT WAS SENT TO SURGERY FOR THROMBECTOMY AND ENDARTERECTOMY OF THE RIGHT LEG. PATIENT LOST PULSES AGAIN AND WENT BACK FOR REDO THROMBECTOMY. APPROXIMATELY 42 HOURS AFTER REMOVING THE IAB, WITHDRAWAL OF LIFE SUPPORT WAS PERFORMED. THE PATIENT EXPIRED DUE TO MULTI-ORGAN FAILURE AND ACUTE CELLULAR REJECTION. THE CUSTOMER DID NOT ATTRIBUTE PATIENT EXPIRATION TO THE IAB.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14778447 ↗
• MalfunctionMar 14, 2022Leak/Splash; Material Deformation; Pressure Problem; Leak/Splash; Material Deformation; Pressure Problem

  IT WAS REPORTED THAT AFTER APPROXIMATELY 10 DAYS OF INTRA-AORTIC BALLOON (IAB) THERAPY THE CONSOLE GENERATED AN ALARM AFTER THE PATIENT WAS BATHED. THE INSERTION WAS REPORTED TO BE RIGHT AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. THE CONSOLE HAD BEEN GENERATING A HIGH PRESSURE ALARM WITH PATIENT MOVEMENT FOR SEVERAL DAYS. IT WAS ALSO NOTED THAT THERE WAS A KINK IN THE IAB. THE CONSOLE WAS NOW GENERATING A LOW ARTERIAL PRESSURE ALARM. BLOOD WAS SEEN IN THE TUBING. THE CONSOLE WAS TURNED OFF AND THE LINE WAS CLAMPED AND DISCONNECTED FROM THE CONSOLE. IAB REMOVAL WAS DELAYED DUE TO ACT 199; ACT 160 AT TIME OF REMOVAL. THE IAB WAS REMOVED ABOUT TWO HOURS LATER AND A NEW ONE WAS PLACED IN THE LEFT AXILLARY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13761545 ↗
• MalfunctionOct 18, 2021Leak/Splash; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647476 ↗
• DeathSep 22, 2021Leak/Splash; Off-Label Use; Leak/Splash; Off-Label Use

  IT WAS REPORTED THAT AFTER APPROXIMATELY 14 DAYS OF INTRA-AORTIC BALLOON (IAB) THERAPY, A CHANGE IN PATIENT MENTATION OCCURRED INCLUDING SEIZURE ACTIVITY AND STROKE ALERT. DURING TRANSPORT, BLOOD WAS SEEN IN THE HELIUM LINE AND THE TUBING WAS CLAMPED. THE INSERTION WAS REPORTED TO BE RIGHT AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. THE IAB WAS REMOVED AND A NEW ONE WAS INSERTED IN THE LEFT AXILLARY. ADDITIONAL INFORMATION RECEIVED 03-NOVEMBER-2021. PATIENT EXPIRED ON(B)(6) 2021.

  Patient problems: Convulsion/Seizure; Stroke/CVA

  MAUDE report 12515039 ↗
• MalfunctionJun 11, 2021Filling Problem; Leak/Splash; Pressure Problem; Filling Problem; Leak/Splash; Pressure Problem

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE PATIENT HAD GOTTEN UP AND THE CONSOLE BEGAN INDICATING THAT IT WAS UNABLE TO FILL AND DISPLAYED NEGATIVE NUMBERS. UPON FURTHER INSPECTION OF THE TUBING, BLOOD WAS SEEN IN THE HELIUM LINE. THE CONSOLE WAS PLACED IN STANDBY MODE AND THE RESPIRATORY THERAPIST (RT) WAS CALLED. THE RT WAS ABLE TO CLAMP THE TUBING PRIOR TO THE BLOOD EVER REACHING THE CONSOLE. THE IAB WAS REMOVED AND A NEW IAB WAS PLACED VIA LEFT AXILLARY WITHOUT ISSUE. APPROXIMATELY ONE DAY LATER, THE SECOND IAB WAS REMOVED AFTER THE PATIENT RECEIVED BIVENTRICULAR ASSIST DEVICE (BIVAD) PLACEMENT. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED. FIRST IAB WAS INSERTED VIA RIGHT AXILLARY. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11982411 ↗