MEGA 7.5 Fr. 40cc IAB (China) 0684-00-0295-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 10607567109039), received between Nov 4, 2020 and Sep 16, 2026 — classified as 2 deaths, 4 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (27 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 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Material Twisted/Bent

  It was reported that during the puncture procedure, the customer found that the guidewire from the MEGA 40cc balloon catheter set was difficult to advance. To ensure the procedure could proceed smoothly, a new set of the product was used. After the replacement, the procedure progressed successfully. When taking photos at the site, customer found that the guidewire was bent. No harm or injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50786967 ↗
• MalfunctionApr 7, 2026Gas/Air Leak

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24798585 ↗
• MalfunctionApr 3, 2026Break

  IT WAS REPORTED THAT DURING WIRE IMPLANTATION, THE WIRE BROKE, RESULTING IN IMPLANTATION FAILURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER REPLACING THE CONSUMABLES. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24773974 ↗
• MalfunctionMar 30, 2026Inflation Problem

  IT WAS REPORTED THAT THE MEGA 40CC HAD MALFUNCTIONED. THE OPERATOR FOUND THAT THE BALLOON WAS ABNORMALLY INFLATED AND THE TRIGGERING FAILED. BECAUSE IT COULD NOT BE INFLATED EFFECTIVELY, THE COUNTERPULSATION COULD NOT DETECT NORMAL GAS FEEDBACK. A NEW INTRA AORTIC BALLOON CATHETER AND ITS ACCESSORIES WERE IMMEDIATELY REPLACED, AND THE SURGERY WAS SUCCESSFULLY PERFORMED. NO PATIENT HARM IS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727881 ↗
• MalfunctionFeb 15, 2026Inflation Problem

  IT WAS REPORTED THAT THE MEGA 40CC HAD INFLATION ISSUE. AFTER BALLOON INSERTION, THE ANTERIOR MEMBRANE OF THE BALLOON CANNOT EXPAND. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341490 ↗
• MalfunctionFeb 15, 2026Inability to Auto-Fill; Positioning Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341487 ↗
• MalfunctionJan 23, 2026Fluid/Blood Leak; Material Rupture; Appropriate Device Problem Term/Code Not Available

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159332 ↗
• MalfunctionJan 21, 2026Leak/Splash; Pressure Problem

  IT WAS REPORTED THAT THE MEGA 40CC IAB CATHETER WAS INSERTED SMOOTHLY. UPON STARTING THE PUMP, AN ALARM INDICATING ¿AUGMENTATION BELOW LIMIT SET¿ WAS TRIGGERED, AND BLOOD WAS OBSERVED IN THE TUBING. THE IAB CATHETER WAS SUBSEQUENTLY REMOVED AND REPLACED WITH A NEW ONE. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128615 ↗
• MalfunctionJan 20, 2026Appropriate Device Problem Term/Code Not Available

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115027 ↗
• MalfunctionJan 13, 2026Restricted Flow rate; Pacing Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24051290 ↗
• MalfunctionDec 2, 2025Pacing Problem; Material Rupture; Pacing Problem; Material Rupture

  IT WAS REPORTED BY CUSTOMER THAT AFTER 30 MINUTES OF INTRA AORTIC BALLOON NORMAL INSERTIONAND LINKING TO IABP, IT COULD NOT BE USED FOR NORMAL PACING. SUBSEQUENTLY, IT WAS FOUND THAT THE BALLOON HAD RUPTURED. AFTER FINALLY CHANGING THE BALLOON, IT CAN BE USED NORMALLY. NO MACHINES WERE DAMAGED AND NO PATIENTS WERE INJURED. THE BALLOON WAS INSERTED FEMORALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696541 ↗
• MalfunctionDec 1, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING USE INTRA-AORTIC BALLOON (IAB) DURING USE, WHEN THE OPERATOR INSERTED THE BALLOON INTO THE BODY, VASOSPASM OCCURRED, AND THE CATHETER HAD DIFFICULTY PASSING THROUGH DUE TO THE REDUCED BLOOD VESSEL DIAMETER, BUT NO ADVERSE EFFECTS WERE CAUSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678979 ↗
• MalfunctionNov 20, 2025Fluid/Blood Leak; Leak/Splash; Material Rupture; Fluid/Blood Leak; Leak/Splash; Material Rupture

  IT REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE BALLOON RUPTURED AND BLEEDING INTO THE INTUBATION. NO INJURIES OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607227 ↗
• MalfunctionNov 20, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON WAS USED TO RESCUE A PATIENT, AFTER IMPLANTING THE IABP BALLOON AND STARTING THE DEVICE, IT WAS FOUND THAT THE IABP BALLOON COULD NOT BE INFLATED NORMALLY. PATIENT WAS INVOLVED. NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23603677 ↗
• MalfunctionNov 17, 2025Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT DURING USE O PATIENT MEGA 40 CC INTRA AORTIC BALLOON (IAB) AFTER SUCCESSFUL FEMORAL ARTERY PUNCTURE, THE PATIENT ENCOUNTERED DIFFICULTY IN THE PROCESS OF BALLOON ADVANCEMENT. EVENTUALLY, THE BALLOON WAS WITHDRAWN AND IT WAS DISCOVERED THAT THERE WAS BLOOD INSIDE THE BALLOON CAVITY. IT WAS BELIEVED THAT THE BALLOON HAD RUPTURED, SO A NEW BALLOON WAS REPLACED. AFTER THE NEW BALLOON WAS REPLACED, IT WAS SUCCESSFULLY IMPLANTED AND THE EQUIPMENT IS OPERATING NORMALLY. THERE WAS NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567039 ↗
• DeathOct 25, 2025Difficult to Insert; Positioning Problem; Difficult to Insert; Positioning Problem

  IT WAS REPORTED THAT INTRA AORTIC BALLOON CATHER, MEGA 40 CC HAD BEND GUIDE-WIRE AND THERE IT WAS DIFFICULT TO ADVANCE AIB THROUGH SHEATH. THE PATIENT EXPIRED.

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23386747 ↗
• InjurySep 17, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED DURING INTRA-AORTIC BALLOON (IAB) THERAPY, A 71-YEAR-OLD MALE PATIENT WAS REPORTED TO REQUIRE IABP SUPPORT FOLLOWING A CORONARY INTERVENTION ON THE AFTERNOON OF (B)(6) 2025. AFTER SUCCESSFUL IMPLANTATION OF THE IABP BALLOON, THE INFLATION AND PACING FUNCTIONS WERE SUBOPTIMAL. THE DEVICE ISSUED AN ALARM, PROMPTING AN INVESTIGATION OF THE IABP CIRCUIT. A DIFFERENT DEVICE WAS EMPLOYED, BUT THE SAME MALFUNCTION WAS OBSERVED. THE PATIENT NECESSITATED SUPPORTIVE CARE. A NEW IABP BALLOON WAS SUBSEQUENTLY INSTALLED, WITH INFLATION AND PACING FUNCTIONS OPERATING NORMALLY.

  Patient problems: Insufficient Information

  MAUDE report 23074788 ↗
• MalfunctionAug 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING INTRA AORTIC BALLOON (IAB) THERAPY "LEAK IN IAB CIRCUIT" OCCURRED AND FOUND BLOOD IN THE TUBING THEN PULL OUT THE IAB CATHETER AND INSERT A NEW ONE. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851515 ↗
• MalfunctionAug 10, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING INTRA AORTIC BALLOON (IAB) THERAPY, COUNTERPULSATION STARTED AFTER THE BALLOON WAS IMPLANTED, AND THE MACHINE INDICATED LOOP LEAKAGE.NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22767892 ↗
• MalfunctionJul 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540039 ↗
• MalfunctionJun 18, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT WHILE USING THE INTRA-AORTIC BALLOON DURING THE PROCESS OF PERFORMING A CARDIAC INTERVENTION SURGERY, THE PATIENT ENCOUNTERED A SITUATION WHERE THE GUIDEWIRE GOT STUCK IN THE BALLOON OF THE AORTIC BALLOON CATHETER AND ITS ASSOCIATED DEVICE, PREVENTING THE BALLOON FROM BEING PROPERLY IMPLANTED. NO INJURIES TO PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282372 ↗
• DeathMay 27, 2025Break; Break

  N.A.

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

  MAUDE report 22085767 ↗
• MalfunctionMar 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21706620 ↗
• MalfunctionFeb 4, 2025Inflation Problem; Leak/Splash; Failure to Pump; Inflation Problem; Leak/Splash; Failure to Pump

  IT WAS REPORTED THAT BALLON CATHETER INTRA-AORTIC BALLOON (IAB) COULD NOT INFLATE FULLY WHEN CONNECTED TO THE CONSOLE. THE CONSOLE WAS NOT WORKING NORMALLY. NO HARM REPORTED.

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

  MAUDE report 21301073 ↗
• MalfunctionJan 17, 2025Break; Fluid/Blood Leak; Material Deformation; Insufficient Device Problem Information; Break; Fluid/Blood Leak; Material Deformation; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING INTRA AORTIC BALLOON (IAB) THERAPY, BLOOD WAS FOUND IN CATHETER AND CONSOLE WAS NOT WORKING NORMALLY. BALLOON WAS REMOVED IMMEDIATELY. THERE WAS NO INJURY OR HARM REPORTED TO THE PATIENT.

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

  MAUDE report 21178361 ↗