MEGA 8Fr. 50cc IAB 0684-00-0498-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 10607567107301), received between Aug 28, 2020 and Sep 29, 2026 — classified as 4 injuries, 109 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (37 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. 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-2220-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Aug 5, 2022Class IIOpen, Classified

   Certain lots containing undersized dilator.

   Z-1685-2022 · Root cause: Vendor change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 113 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928241 ↗
• MalfunctionSep 29, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927781 ↗
• MalfunctionSep 28, 2026Failure to Advance; Material Deformation

  It was reported that the physician was unable to advance the MEGA 50cc balloon catheter because it had become kinked. Another balloon catheter was inserted to continue treatment. The engineer inspected the device and ruled out any device malfunction. No harm to the patient reported. Resistance was encountered during insertion, advancement of the IAB. The kink was located on the tip of the catheter.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913348 ↗
• MalfunctionSep 17, 2026Failure to Advance; Material Deformation

  It was reported that during the MEGA 50cc Intra-Aortic Balloon (IAB) catheter insertion the lower end of the catheter was found to be bent, preventing it from being advanced to the intended position. Despite repeated attempts, the insertion was unsuccessful. No harm to the patient reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50799481 ↗
• MalfunctionSep 16, 2026Difficult to Insert; Material Integrity Problem

  It was reported that during insertion of MEGA 50cc balloon catheter the customer noticed that balloon shaft section was too soft, making it impossible to advance smoothly through the sheath over the guidewire. After replacing it with another balloon catheter, the device was successfully inserted. No harm to the patient reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50784766 ↗
• InjuryAug 30, 2026Difficult to Insert; Difficult to Remove; Material Integrity Problem

  Patient problems: Insufficient Information

  MAUDE report 50514645 ↗
• MalfunctionAug 28, 2026Difficult to Insert; Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50493210 ↗
• MalfunctionFeb 23, 2026Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING USE, THE INTRA-AORTIC BALLOON RUPTURED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414040 ↗
• MalfunctionFeb 17, 2026Inability to Auto-Fill

  IT WAS REPORTED THAT AFTER INSERTING THE MEGA 50 BALLOON (IAB), THE MACHINE ALARMED THAT AUTOMATIC INFLATION HAD FAILED DURING USE. THE ALARM PERSISTED AFTER MULTIPLE ATTEMPTS. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363924 ↗
• MalfunctionJan 30, 2026Break; Material Integrity Problem; Material Twisted/Bent; Positioning Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE INTRA-AORTIC BALLOON PUMP(IABP) GUIDEWIRE BENT AFTER BEING INSERTED INTO THE BLOOD VESSEL. DURING THE SUBSEQUENT CATHETER REPLACEMENT, THE GUIDEWIRE BROKE. A NEW GUIDEWIRE WAS THEN USED TO COMPLETE THE TREATMENT. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219365 ↗
• MalfunctionJan 23, 2026Leak/Splash; Appropriate Device Problem Term/Code Not Available

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160195 ↗
• MalfunctionDec 26, 2025Restricted Flow rate; Fluid/Blood Leak; Restricted Flow rate; Fluid/Blood Leak

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23894984 ↗
• MalfunctionDec 15, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT THE MEGA 50CC HAD TRIGGERING A BLOOD LEAKAGE ALARM ISSUE. CATHETER RUPTURE COULD LEAD TO TREATMENT FAILURE AND EQUIPMENT DAMAGE. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803291 ↗
• MalfunctionNov 28, 2025Difficult to Insert; Difficult to Insert

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23671029 ↗
• MalfunctionNov 24, 2025Difficult to Insert; Positioning Problem; Difficult to Insert; Positioning Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633950 ↗
• MalfunctionNov 20, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING IMPLANTATION OF BALLOON CATHETER INTRA-AORTIC BALLOON (IAB), THE CATHETER COULD NOT BE INSERTED INTO THE DESIGNATED LOCATION DUE TO TORTUOUS BLOOD VESSELS AND A BENT CATHETER.THEREFORE, IT WAS REMOVED AND ANOTHER BALLOON WAS IMPLANTED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604603 ↗
• MalfunctionNov 16, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB). THE PATIENT PRESENTED WITH ACUTE MYOCARDIAL INFARCTION, HYPOTENSION, AND BRADYCARDIA. EMERGENCY CORONARY ANGIOGRAPHY REVEALED RIGHT CORONARY OCCLUSION, AND ONE STENT WAS IMPLANTED. DURING AND AFTER THE PROCEDURE, THE PATIENT EXPERIENCED PERSISTENT HYPOTENSION AND WAS GIVEN TEMPORARY PACING AND INTRA-AORTIC BALLOON COUNTERPULSATION (IABP) SUPPORT. ON THE FIRST POST-PROCEDURE DAY, THE PATIENT'S BLOOD PRESSURE AND HEART RATE WERE STABLE WHEN THE IABP MACHINE SUDDENLY ALARMED AND STOPPED. THE PATIENT WAS RUSHED TO THE BEDSIDE, WHERE THE IABP EXTENSION TUBE WAS FOUND TO BE FILLED WITH RED, BUBBLY MATERIAL, SUGGESTING A RUPTURED IABP BALLOON MEMBRANE. NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23565439 ↗
• MalfunctionOct 15, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE INTRA-AORTIC BALLOON THERAPY, THE INFLATION WAS POOR AND THE PATIENT'S CONDITION WAS CRITICAL. AFTER IMMEDIATE REPLACEMENT, THE INFLATION WAS GOOD AND THE PATIENT WAS OUT OF DANGER. THE OPERATION WAS SUCCESSFUL AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299498 ↗
• MalfunctionSep 11, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED DURING THE INTRA-AORTIC BALLOON THERAPY THAT THE GUIDEWIRE COULD NOT SMOOTHLY PASS THROUGH THE CATHETER LUMEN. AS A RESULT, THE TREATMENT WAS DELAYED. NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025309 ↗
• MalfunctionAug 10, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED BY CUSTOMER THAT DURING EMERGENCY, GETINGE INTRA AORTIC BALLOON WAS INSERTED INTO THE PATIENT WITHOUT ANY RESISTANCE. AFTER IMPLANTATION, THERE WAS NO PRESSURE WHEN THE PRESSURE SENSOR WAS CONNECTED. THERE WAS NO BLOOD IN THE CENTRAL CAVITY AFTER ASPIRATION. AFTER REPEATED FAILED ATTEMPTS, A NEW BALLOON WAS IMPLANTED AND EVERYTHING WAS NORMAL. COUNTERPULSATION WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22768101 ↗
• MalfunctionJul 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON WAS INSERTED TO ASSIST THE HEART FUNCTION OF THE PATIENT. THE NURSE IN CHARGE FOUND THAT THE IABP CATHETER WAS LEAKING BLOOD. THE DOCTOR CHECKED AND CONFIRMED THAT THE IABP BALLOON WAS RUPTURED. NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22646386 ↗
• MalfunctionJul 22, 2025Difficult to Insert; Damaged Thread; Difficult to Insert; Damaged Thread

  IT WAS REPORTED THAT DURING TREATMENT WITH THE INTRA-AORTIC BALLOON (IAB) THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO ACUTE MYOCARDIAL INFARCTION. HIS CONDITION CHANGED AND HE BECAME CONFUSED. HE UNDERWENT EMERGENCY IABP IMPLANTATION AND AN INTRAAORTIC BALLOON PUMP WAS INSTALLED DURING THE OPERATION. AFTER THE AORTIC BALLOON CATHETER WAS CONNECTED TO THE MACHINE, THE EQUIPMENT DID NOT WORK PROPERLY AND A DISTORTED SCREEN APPEARED. NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563146 ↗
• MalfunctionJul 21, 2025Difficult to Advance; Difficult to Advance

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553301 ↗
• MalfunctionJul 21, 2025Leak/Splash; Infusion or Flow Problem; Leak/Splash; Infusion or Flow Problem

  IT WAS REPORTED WHEN THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO ACUTE MYOCARDIAL INFARCTION. HE UNDERWENT EMERGENCY IABP IMPLANTATION AND AN INTRAAORTIC BALLOON CATHETER WAS CONNECTED TO THE MACHINE, THE BALLOON COULD NOT BE INFLATED AND THE EQUIPMENT COULD NOT WORK PROPERLY. AFTER CHECKING THE AIRWAY FOR BLOOD, THE BALLOON CATHETER OF THE SAME BRAND AND MODEL WAS IMMEDIATELY REPLACED. THE EQUIPMENT OPERATED NORMALLY AND THE AUXILIARY SUPPORT WAS NORMAL. THE ORIGINAL BALLOON CATHETER THAT WAS REMOVED WAS REPORTED AS DAMAGED. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552817 ↗
• MalfunctionJul 17, 2025Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT THE BEFORE INTRA-AORTIC BALLOON IMPLANTATION, THE NEGATIVE PRESSURE WAS INSUFFICIENT, WHICH LED TO THE FAILURE OF THE IMPLANTATION. THE BALLOON WAS DEFORMED AND DAMAGED. THE PATIENT SUFFERED NO HARM AND THE MACHINE DID NOT SUFFER ANY LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22535537 ↗