MEGA 7.5Fr. 40cc IAB 0684-00-0295-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10607567107974), received between Sep 14, 2020 and Sep 2, 2025 — classified as 4 deaths, 4 injuries, 30 malfunctions.

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

2 FDA recall records name this device's identifier, 2 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. Sep 17, 2024Class IIOpen, Classified

   There is discrepant labeling on the inner and outer packaging of the device.

   Z-0311-2025 · Root cause: Error in labeling · Recall details · FDA record ↗

2. 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Restricted Flow rate; Off-Label Use; Material Deformation; Migration; Restricted Flow rate; Off-Label Use; Material Deformation; Migration

  (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931527 ↗
• DeathJul 24, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED DURING USE, THROUGH THE EMERGENCY SUPPORT LINE, THAT THE PATIENT HAD LOW BLOOD PRESSURE WITH HIGH AUGMENTATION. AN X-RAY IMAGE WAS REVIEWED WHICH SHOWED THE IAB MARKER AT THE 8TH INTERCOSTAL SPACE, INDICATING THE BALLOON WAS POSITIONED LOW. THE USER WAS ADVISED TO NOTIFY THE PROVIDER. APPROXIMATELY ONE HOUR LATER, THE USER CALLED BACK AND SHARED ANOTHER X-RAY SCREENSHOT, WHICH SHOWED THAT THE BALLOON POSITION REMAINED RELATIVELY UNCHANGED AND WAS NOTED TO BE ALMOST AT THE HUB. IT WAS RECOMMENDED TO RETURN THE PATIENT TO THE CATH LAB FOR FURTHER EVALUATION UNDER FLUOROSCOPY, AS THE RADIOPAQUE TIP SHOULD BE POSITIONED BETWEEN THE 2ND AND 3RD INTERCOSTAL SPACE. THE PATIENT EXPIRED.

  Patient problems: Myocardial Infarction

  MAUDE report 22586021 ↗
• MalfunctionJun 27, 2025Gas/Air Leak; Gas/Air Leak

  NURSE CALLED INTO THE EMERGENCY SUPPORT LINE AFTER THE INTRA-AORTIC BALLOON (IAB) HAD A REPEATED LEAK IN IAB CIRCUIT ALARM DURING USE. NO PATIENT HARM OR INJURY REPORTED. NO BLOOD OR DISCOLORATION WAS IN THE HELIUM TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344635 ↗
• MalfunctionNov 18, 2024Break; Break

  IT WAS REPORTED THAT THE IAB INTRODUCER HUB BROKE. THE CUSTOMER WAS ABLE TO RETRIEVE IT. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20709507 ↗
• MalfunctionOct 31, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT UNDER IMAGING, ONE RADIOPAQUE MARKER ON THE INTRA-AORTIC BALLOON (IAB) APPEARED TO BE MISSING. THIS OCCURRED AFTER TWO DAYS OF THERAPY. IT WAS ALSO NOTED THAT AN AUTOFILL FAILURE ALARM WAS GENERATED. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. THE CUSTOMER WAS UNABLE TO TROUBLESHOOT BUT THE CONSOLE AND IAB FUNCTION WERE OTHERWISE APPROPRIATE, AND THE BEDSIDE TEAM DEFERRED REPLACING THE CATHETER AND LEFT THE CURRENT IAB IN USE. THE IAB WAS THEN REMOVED OF THREE DAYS OF USE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582245 ↗
• MalfunctionOct 30, 2024Inability to Auto-Fill; Inability to Auto-Fill

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, NATALIE HAD A PATIENT ON A IABP THAT WAS ALARMING "AUTOFILL FAILURE". NATALIE SAID THAT THEY DECIDED TO REMOVE THE IAB. THERE WAS NO BLOOD IN THE HELIUM TUBING, AND THEY FELT THE CATHETER WAS LIKELY KINKED OR MOVED. THEY WOULD REPLACE THE IAB. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570243 ↗
• MalfunctionSep 30, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT MEGA 40CC INTRA-AORTIC BALLOON (IAB) WAS MISPACKAGED AS A MEGA 50CC IAB. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334428 ↗
• MalfunctionJun 26, 2024Component Misassembled; Component Misassembled

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19620095 ↗
• MalfunctionMar 28, 2024Inability to Auto-Fill; Difficult to Insert; Inability to Auto-Fill; Difficult to Insert

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991298 ↗
• InjuryFeb 12, 2024Leak/Splash; Migration; Leak/Splash; Migration

  N/A.

  Patient problems: Hematoma; Pseudoaneurysm

  MAUDE report 18687165 ↗
• MalfunctionNov 9, 2023Leak/Splash; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107927 ↗
• MalfunctionOct 3, 2023Inappropriate Waveform; Inappropriate Waveform

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860978 ↗
• MalfunctionSep 19, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER APPROXIMATELY SEVEN HOURS OF INTRA-AORTIC BALLOON (IAB) THERAPY, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) GENERATED A LEAK IN IAB CIRCUIT ALARM AND STOPPED THERAPY. THERE WAS A SLOW HELIUM LEAK. THE CUSTOMER CONFIRMED THAT THE IAB WAS LEAKING AS THE SAME ISSUE OCCURRED WHEN IT WAS CONNECTED TO ANOTHER IABP. THERAPY WAS CONCLUDED AFTER 12 HOURS. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED. THIS REPORT IS FOR THE IAB INVOLVED IN THE EVENT. A SEPARATE REPORT HAS BEEN SUBMITTED FOR THE CARDIOSAVE IABP UNDER MFG REPORT NUMBER 2249723-2023-01661.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17773910 ↗
• MalfunctionAug 1, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE CONSOLE GENERATED A CATHETER RESTRICTION ALARM THAT HAD BEEN GOING OFF FOR SEVERAL MINUTES. HE WAS NOT ABLE TO RESUME THERAPY. AS THE CALL BEGAN, THE GETINGE REPRESENTATIVE COULD HEAR A LOT OF ACTIVITY IN THE ROOM AND THE CUSTOMER SEEMED VERY DISTRACTED. THE CUSTOMER STATED THE IAB HAD BEEN IN FOR ABOUT A WEEK. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. THE CUSTOMER WAS THEN INSTRUCTED TO ASSESS THE INSERTION SITE AND REPOSITION THE PATIENT¿S ARM/SHOULDER. THEY STATED THEY¿VE DONE THAT AND PROMPTLY SAID THEY WERE JUST GOING TO REPLACE THE IAB SINCE THEY COULD NOT GET PUMPING TO RESUME. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435946 ↗
• MalfunctionJul 19, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER INSERTING THE INTRA-AORTIC BALLOON (IAB), THE PHYSICIAN HAD A QUESTION ABOUT THE RADIOPAQUE TIP AND WHAT LIES BEYOND THE DISTAL TIP ON THE IAB. HE DESCRIBED SEEING WHAT APPEARED TO BE A "SHADOW" BEYOND THE TIP AND WAS CONCERNED THAT THAT THERE MIGHT BE AN ISSUE WITH THE IAB. A FACETIME CALL WAS MADE TO SEE THE FLEURO SCREEN AND THE GETINGE REPRESENTATIVE WAS ABLE TO OBSERVE THE DARKER RADIOPAQUE TIP. THE GETINGE REPRESENTATIVE ALSO SAW A LIGHTER SHADE BEYOND THE TIP THAT APPEARED TO BE IN THE SAME SHAPE AND DIAMETER. IT WAS ADVISED THAT THERE WAS A SMALL PIECE BEYOND RADIOPAQUE TIP THAT CONCLUDES THE DISTAL END, BUT IT WAS NOT RADIOPAQUE AND THAT "SHADING" BEYOND THE TIP WAS NOT SOMETHING OFTEN SEEN. SEVERAL MINUTES LATER, THE PHYSICIAN CALLED BACK TO REPORT THAT THEY HAD OPENED ANOTHER MEGA 40CC IAB AND PLACED IT UNDER FLEUROSCOPY BEFORE INSERTING INTO THE PATIENT. THEY SAW THE SAME DARKENED SHADOW BEYOND THE DISTAL RADIOPAQUE TIP AND FELT MORE COMFORTABLE THAT THE FIRST IAB WAS OKAY TO USE AND DECIDED TO LEAVE IT IN THE PATIENT. THEY ALSO QUESTIONED AT THAT POINT IF THEIR FLEURO DEVICE WAS CAUSING THE ISSUE. THE IAB WAS IN USE FOR APPROXIMATELY SEVEN DA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17356582 ↗
• MalfunctionJun 12, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE CONSOLE GENERATED A CATHETER RESTRICTION ALARM POST-OP. THE CUSTOMER COMPLETED A CHEST FILM AND THEY BELIEVED THE IAB WAS IN THE CORRECT POSITION. THE CONSOLE WAS SWITCHED OUT BUT THE SAME ISSUE OCCURRED. PUMPING WAS CONTINUED. THEY HAD THE AUGMENTATION CONTROL DIALED TO "70 PERCENT" AND IT HAD NOT ALARMED AGAIN, BUT THEIR AUGMENTATION WAS ONLY IN THE 60S. SYSTOLIC BLOOD PRESSURE (BP) WAS IN THE 90S AND IT WAS NOTED THAT THE PATIENT WAS ON MULTIPLE VASOPRESSORS. THEY WERE ADVISED TO CONFIRM THAT THE LOCATION WAS GOOD. THERE WAS NO BLOOD OR VISIBLE KINKS IN THE HELIUM TUBING. THE PATIENT WAS VENTILATED, SEDATED, AND NOT MOVING. THEY WERE THEN ADVISED TO TRY GOING BACK UP SLOWLY WITH THE AUGMENTATION CONTROL AND THE CONSOLE GENERATED THE SAME ALARM IMMEDIATELY AT THIS. THE "FILL" KEY WOULD NOT RESUME PUMPING. THEY TRIED LOG ROLLING THE PATIENT WITHOUT SUCCESS. THE AUGMENTATION WAS DIALED BACK DOWN AND THEY WERE ABLE TO RESUME PUMPING. THEY SPOKE WITH THE PHYSICIANS ABOUT THE ISSUE AND WERE DISCUSSING REMOVAL AND POSSIBLE REPLACEMENT. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17106627 ↗
• MalfunctionMay 31, 2023Device Alarm System; Leak/Splash; Device Alarm System; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17034561 ↗
• DeathMay 11, 2023Device Alarm System; Leak/Splash; Material Deformation; Device Alarm System; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, AN IAB RUPTURE OCCURRED WITH BLOOD BACKING UP INTO HELIUM TUBING. THE CUSTOMER WAS UNABLE TO PROVIDE FURTHER INFORMATION REGARDING ALARMS OR CLINICAL SITUATION. THE CRITICAL PATIENT WAS UNABLE TO BE SUPPORT WITH THERAPY AND HAD TO BE RESUSCITATED. REPORTED VIA MEDWATCH REPORT #MW5117071 RECEIVED 03MAY2023: WHILE PATIENT WAS IN INTENSIVE CARE UNIT BLOOD WAS NOTED IN THE INTRA-AORTIC BALLOON PUMP HELIUM LINE, WHICH HAD BEEN IN PLACE FOR 23 HOURS, REQUIRING IMMEDIATE SHUT OFF OF DEVICE. PATIENT SUFFERED CARDIAC ARREST LEADING TO THROMBOSIS, INADEQUATE PERFUSION, FAMILY DECISION TO PLACE ON COMFORT CARE, AND DEATH. RECEIVED ON 10MAY2023: 82F PRESENTED TO OUTSIDE HOSPITAL, FOUND TO HAVE NSTEMI, TRANSPORTED TO (B)(6). PATIENT FOUND TO HAVE LEFT MAIN DISEASE AND MULTIVESSEL CAD DURING (B)(6) 2023 CARDIAC CATH; 40CC IABP PLACED FOR CHEST PAIN DURING PCI. PATIENT TRANSFERRED TO ICU AND WAS IN STABLE CONDITION. NO COMPLICATIONS NOTED DURING PLACEMENT OR DURING PUMPING. ON (B)(6) 2023, ABOUT 22 HOURS AFTER INSERTION, THE MACHINE SHOWED AN ¿IAB CATHETER RESTRICTION¿ ALARM AND WHEN THE RN ASSESSED FOR A KINK IN THE LINE, SHE VISUAL

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cardiac Arrest; No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 16916007 ↗
• MalfunctionApr 11, 2023Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT AFTER INSERTING THE INTRA-AORTIC BALLOON (IAB), THE CONSOLE GENERATED A GAS LOSS IN IAB CIRCUIT ALARM FOR A POSSIBLE HELIUM LEAK. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. NO BLOOD WAS FOUND IN THE HELIUM TUBING. THERE WAS A POSSIBILITY OF A KINK IN THE IAB OR LEAKAGE PROBLEM FROM THE CONSOLE. THE IAB WAS REMOVED AFTER A FEW HOURS OF THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16715742 ↗
• MalfunctionApr 10, 2023Inappropriate Waveform; Pressure Problem; Inappropriate Waveform; Pressure Problem

  IT WAS REPORTED THAT AFTER INSERTING THE INTRA-AORTIC BALLOON (IAB), THE ARTERIAL PRESSURE WAVEFORM WAS NOT DISPLAYED. IT WAS NOTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) GENERATED A NO TRIGGER ALARM. THE CUSTOMER EXCHANGED AND CONNECTED THE IAB TO A DIFFERENT CARDIOSAVE IABP, BUT THE ISSUE PERSISTED. THE IAB WAS THEN REPLACED WITH A NEW ONE, BUT THE SAME PROBLEM OCCURRED AGAIN. THE IABP WAS SWITCHED AGAIN WITH ANOTHER CARDIOSAVE BUT THIS DID NOT RESOLVE THE ISSUE. THE SECOND IAB WAS ALSO REMOVED. SINCE THE PATIENT WAS STABLE, NO FURTHER IABS WERE INSERTED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED. THIS REPORT IS FOR THE 2ND IAB USED. A SEPARATE REPORT HAS BEEN SUBMITTED FOR THE 1ST IAB UNDER MFG REPORT NUMBER 2248146-2023-00239.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16706619 ↗
• MalfunctionApr 6, 2023Inappropriate Waveform; Pressure Problem; Inappropriate Waveform; Pressure Problem

  IT WAS REPORTED THAT AFTER INSERTING THE INTRA-AORTIC BALLOON (IAB), THE ARTERIAL PRESSURE WAVEFORM WAS NOT DISPLAYED. IT WAS NOTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) GENERATED A NO TRIGGER ALARM. THE CUSTOMER CONNECTED THE IAB TO A DIFFERENT CARDIOSAVE IABP, BUT THE ISSUE PERSISTED. THE IAB WAS THEN REPLACED WITH A NEW ONE, BUT THE SAME PROBLEM OCCURRED AGAIN. THE IABP WAS SWITCHED AGAIN WITH ANOTHER CARDIOSAVE BUT THIS DID NOT RESOLVE THE ISSUE. THE SECOND IAB WAS ALSO REMOVED. SINCE THE PATIENT WAS STABLE, NO FURTHER IABS WERE INSERTED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED. THIS REPORT IS FOR THE 1ST IAB USED IN THIS EVENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE 2ND IAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691351 ↗
• DeathMar 30, 2023Break; Break

  IT WAS REPORTED THAT DURING THE INSERTION PROCESS OF THE INTRA-AORTIC BALLOON (IAB), THE SHEATH DILATOR BROKE OFF AT THE HUB AND ENDED UP IN THE AORTA OF THE PATIENT. IN THE RETRIEVAL PROCESS, THE AORTA WAS PERFORATED. A NEW IAB WAS NOT INSERTED. THE PATIENT LATER PASSED AWAY.

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

  MAUDE report 16648701 ↗
• MalfunctionMar 7, 2023Device Alarm System; Leak/Splash; Device Alarm System; Leak/Splash

  IT WAS REPORTED THAT AFTER INSERTING THE INTRA-AORTIC BALLOON (IAB), THE CONSOLE GENERATED A CATHETER RESTRICTION ALARM. IT WAS DISCOVERED THAT THE IAB HAD BEEN TORN UPON INSERTION. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16494590 ↗
• MalfunctionJan 3, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER APPROXIMATELY 21 DAYS OF INTRA-AORTIC BALLOON (IAB) THERAPY, THE CONSOLE GENERATED A CATHETER RESTRICTION ALARM. A SHORT TIME LATER, A RUPTURE OCCURRED AND BLOOD WAS SEEN IN THE TUBING. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. A NEW IAB WAS SUCCESSFULLY INSERTED VIA RIGHT AXILLARY TO CONTINUE THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16090187 ↗
• MalfunctionNov 22, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER APPROXIMATELY TWO DAYS OF INTRA-AORTIC BALLOON (IAB) THERAPY, THE PUMP GENERATED A GAS GAIN IN THE IAB CIRCUIT ALARM. BLOOD WAS FOUND IN THE EXTENSION TUBING OF THE CATHETER AND ENTERED THE PUMP. THE CUSTOMER IMMEDIATELY STOPPED THERAPY, INSERTED A NEW IAB, AND SWAPPED OUT THE PUMP. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15848816 ↗