MEGA 7.5Fr. 30cc IAB 0684-00-0294-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10607567107950), received between Feb 24, 2021 and Mar 31, 2026 — classified as 2 deaths, 9 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Fluid/Blood Leak; Leak/Splash; Material Rupture

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747069 ↗
• MalfunctionMar 19, 2026Pacing Problem; Obstruction of Flow; Inappropriate Waveform

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637038 ↗
• MalfunctionJan 23, 2026Obstruction of Flow; Inappropriate Waveform; Pressure Problem

  (B)(6), AN ICU RN, CALLED INTO EMERGENCY SUPPORT PROGRAM LINE TO REQUEST SUPPORT FOR ASSISTANCE WITH THE ARTERIAL WAVEFORM ON A CARDIOSAVE WITH A MEGA 30CC CATHETER DURING USE. (B)(6) SHARED PHOTO ASKING WHICH ARTERIAL ACCESS PORT SHOULD TRANSDUCE FOR THERAPY. THE FIRST IMAGE WAS FROM THE INNER LUMEN. THE SECOND IMAGE WAS FROM AN ARTERIAL PIGTAIL FROM THE SHEATH. ESP PERSONNEL INFORMED HER THAT THE MOST ACCURATE PRESSURES FOR THERAPY WILL BE FROM THE INNER LUMEN. OFF-BRAND DISCLAIMER PROVIDED AS WELL. (B)(6) CALLED AGAIN AT 5:09 PM EST, SAYING THE ARTERIAL WAVEFORM AND PRESSURES WERE FLAT AND HIGH. SHE SHARED AN IMAGE OF THE PUMP SCREEN SHOWING PRESSURES OF 210/207 (209) AND AN AUGMENTATION OF 210. TROUBLESHOOTING PERFORMED DETERMINED THE INNER LUMEN WAS CLOTTED (UNABLE TO ASPIRATE) AND THE BEDSIDE TEAM CAPPED THE INNER LUMEN, LABELING AS ¿DO NOT USE, CLOTTED INNER LUMEN¿ AND TRANSITIONED TO THE ARTERIAL PIGTAIL ACCESS OFF THE SHEATH IN PLACE. COMPLAINT INFORMATION OBTAINED. AN UPDATED IMAGE SHOWED AN IMPROVED WAVEFORM BUT SUBOPTIMAL AUGMENTATION. THEY DISCUSSED POSSIBLE CAUSES OF SUBOPTIMAL AUGMENTATION, AND ESP PERSONNEL ENCOURAGED (B)(6) TO NOTIFY THE PROVIDER FOR FURTHER INTERV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159235 ↗
• MalfunctionJul 22, 2025Pacing Problem; Off-Label Use; Incorrect, Inadequate or Imprecise Result or Readings; Pacing Problem; Off-Label Use; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER CALLED TO REPORT THAT WHILE USING INTRA-AORTIC BALLOON, THE A-LINE IS NOT READING PROPERLY. IT OCCURRED DURING USE AND NO PATIENT HARM OR INJURY REPORTED. CUSTOMER ALSO STATED THE BALLOON WAS AXILLARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563302 ↗
• MalfunctionMar 6, 2025Device Contaminated During Manufacture or Shipping; Moisture or Humidity Problem; Device Contaminated During Manufacture or Shipping; Moisture or Humidity Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21534943 ↗
• MalfunctionJun 20, 2023Inability to Auto-Fill; Gas/Air Leak; Inability to Auto-Fill; Gas/Air Leak

  IT WAS REPORTED THAT AFTER APPROXIMATELY THREE TO FOUR HOURS OF INTRA-AORTIC BALLOON (IAB) THERAPY, THE CONSOLE GENERATED GAS LOSS IN IAB CIRCUIT ALARM AND AN AUTOFILL FAILURE OCCURRED. IT WAS NOTED THAT THE PATIENT WAS LYING STILL IN BED IN SUPINE POSITION WITH REVERSE TRENDELENBURG WHEN THIS ISSUE OCCURRED. THE CUSTOMER POWERED THE CONSOLE OFF AND ON, AND AFTER APPROXIMATELY FIVE TO EIGHT MINUTES, THEY WERE ABLE TO FILL THE IAB AND RESUME PUMPING. THE IAB WAS REMOVED THE NEXT DAY AFTER APPROXIMATELY 24 HOURS OF THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164612 ↗
• MalfunctionFeb 9, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER A FEW HOURS OF INTRA-AORTIC BALLOON (IAB) THERAPY BLOOD WAS NOTICED IN THE HELIUM TUBING. IT WAS NOTED THAT THE PATIENT HAD BEEN TRANSFERRED IN FROM ANOTHER FACILITY THREE HOURS PRIOR. THE CONSOLE WAS PUT ON STAND-BY AND THE IAB WAS EVENTUALLY REPLACED WITH A NEW ONE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16337494 ↗
• DeathJan 3, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER APPROXIMATELY 16 DAYS OF INTRA-AORTIC BALLOON (IAB) THERAPY, THE PUMP GENERATED A CATHETER RESTRICTION ALARM AND A RUPTURE OCCURRED. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. THE IAB WAS REMOVED. BASED UPON RISKS/BENEFITS A NEW IAB WAS NOT INSERTED. THE PATIENT EXPIRED ON (B)(6) 2022.

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

  MAUDE report 16091456 ↗
• MalfunctionAug 2, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE CUSTOMER COULD NOT INSERT THE INTRA-AORTIC BALLOON (IAB) OVER THE GUIDEWIRE. THEY NOTED THAT IT WOULD NOT THREAD. A NEW IAB WAS INSERTED TO CONTINUE THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15150751 ↗
• MalfunctionJul 6, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE IAB RUPTURED AND BLOOD WAS SEEN IN THE TUBING. THE IAB WAS REMOVED THE SAME DAY AND A REPLACEMENT WAS INSERTED THE NEXT DAY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12122230 ↗
• DeathFeb 24, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO CARDIAC THEATRE FOR EMERGENCY SURGERY. PATIENT ARRESTED IN OPERATING THEATRE PRIOR TO THE COMMENCEMENT OF SURGERY. DURING A PROLONGED RESUSCITATION PROCESS THE PHYSICIANS ATTEMPTED THE INSERTION OF THREE INTRA-AORTIC BALLOON(IAB) CATHETERS. RESUSCITATION WAS UNSUCCESSFUL AND THE PATIENT SUBSEQUENTLY DIED. THE CAUSE OF DEATH WAS STATED AS PULMONARY ARTERY TEAR. THE NOTES ALSO SAID THERE WAS AN AORTIC RUPTURE COMPLICATED FROM IAB INSERTION AND IAB CATHETER RUPTURE. THE CUSTOMER SAID THEY DID NOT BELIEVE THE IAB INSERTION HAD CONTRIBUTED TO THE PATIENTS UNFORTUNATE DEATH. THIS REPORT IS FOR THE 1ST IAB USED. A SEPARATE REPORT WILL BE SUBMITTED FOR THE 2ND AND 3RD IAB.

  Patient problems: Cardiac Arrest; Death

  MAUDE report 11375863 ↗