MEGA 8Fr. 50cc IAB with Accessories, US Only 0684-00-0296-01URecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10607567109619), received between Sep 11, 2023 and Sep 25, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Restricted Flow rate; Device Sensing Problem; Infusion or Flow Problem

  During an Emergency Support Program call, an ICU RN reported Suboptimal Augmentation on a CARDIOSAVE Intra-Aortic Balloon Pump (IABP) during use with a left axillary MEGA 8Fr. 50cc Intra-Aortic Balloon (IAB) catheter. After troubleshooting, the IAB waveform remained abnormal and suggestive of a possible catheter restriction, which may have been related to catheter position or patient positioning. No patient harm or injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896219 ↗
• MalfunctionSep 15, 2026Fluid/Blood Leak; Material Rupture; Failure to Unfold or Unwrap; Obstruction of Flow; Material Twisted/Bent

  During an Emergency Support Program call, an RN reported an IAB Restriction alarm on a CARDIOSAVE Intra-Aortic Balloon Pump (IABP) while using a MEGA 8Fr. 50cc IAB catheter. During initial troubleshooting, no visible blood was identified in the helium tubing; however, several minutes later, the customer observed serosanguinous, pinkish/rust-colored fluid in the large-bore helium tubing of the IAB catheter. Troubleshooting was discontinued, and the customer was advised to disconnect the IAB catheter from the CARDIOSAVE and clamp the IAB. The customer completed these actions while on the call, while another team member contacted the cardiothoracic surgeon to facilitate IAB removal or replacement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50770932 ↗
• InjuryAug 31, 2026Fluid/Blood Leak; Difficult to Remove; Material Rupture

  During an Emergency Support Program call, the customer reported blood in the helium tubing of a CARDIOSAVE Intra-Aortic Balloon Pump (IABP) while supporting a patient with an axillary-placed MEGA 8Fr. 50cc Intra-Aortic Balloon (IAB) that had been in place for approximately 30 days. Review of the provided image confirmed blood in the helium tubing, consistent with IAB perforation. The patient was also receiving ECMO therapy and was in CT at the time of the call.The customer was advised to immediately discontinue IABP therapy, disconnect the helium tubing from the pump, clamp the extracorporeal tubing, and notify the physician for immediate IAB removal. The risks associated with continued therapy and potential IAB entrapment were reviewed, and the customer was advised not to resume therapy. The CT RN was contacted to ensure the recommendations were communicated and followed. The patient was subsequently transported to the Operating Room for IAB removal.During the removal procedure, the cardiac surgeon reported difficulty removing the IAB and anticipated a surgical cutdown. Device-related information consistent with the IFU was provided, including consideration of arteriotomy if cathe

  Patient problems: Insufficient Information

  MAUDE report 50517831 ↗
• MalfunctionAug 19, 2026Fluid/Blood Leak; Difficult to Insert; Unraveled Material; Material Perforation

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50320527 ↗
• InjuryAug 3, 2026Material Rupture

  It was reporter that a MEGA 8Fr. 50cc Intra-Aortic Balloon (IAB) ruptured while providing mechanical circulatory support to a critically ill patient, necessitating removal and replacement of the device. The event resulted in patient harm.

  Patient problems: Insufficient Information

  MAUDE report 50114165 ↗
• InjuryMar 28, 2025Leak/Splash; Leak/Splash

  AFTER INSERTING TWO MEGA 8 FR 50CC IAB CATHETERS IN THE SAME PATIENT, THE USER ENCOUNTERED THE FOLLOWING ALARMS ON THE CARDIOSAVE IABP: "CHECK IAB CATHETER" AND "LEAK IN IAB SYSTEM." AS A RESULT, THERAPY COULD NOT BE INITIATED, AND THE PATIENT¿S CIRCULATORY SUPPORT HAD TO BE MANAGED WITH ALTERNATIVE MEDICATIONS. WHILE BOTH ALARMS ARE CATHETER-RELATED, A SERVICE TECHNICIAN HAD INSPECTED THE CARDIOSAVE IABP EARLIER THAT DAY AND FOUND NO MALFUNCTIONS. THIS SUGGESTS THAT THE ISSUE IS LIKELY WITH THE IAB CATHETERS RATHER THAN THE PUMP ITSELF.

  Patient problems: Insufficient Information

  MAUDE report 21718258 ↗
• MalfunctionOct 14, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING INSERTION, THE INTRA-AORTIC BALLOON (IAB) WAS UNABLE TO BE INSERTED THROUGH THE INCLUDED 8FR SHEATH. AFTER SEVERAL ATTEMPTS, THEY OPTED TO SWITCH THE SHEATH TO A PINNACLE 8 FR SHEATH. THIS WAS SUCCESSFUL AND THERAPY WAS PROVIDED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20442159 ↗
• MalfunctionAug 21, 2024Material Deformation; Pressure Problem; Material Deformation; Pressure Problem

  IT WAS REPORTED THAT IMMEDIATELY AFTER INSERTING THE INTRA-AORTIC BALLOON (IAB), THE CONSOLE GENERATED AN ALARM AND IT WAS NOTED THAT THE AORTIC PRESSURES WERE READING HIGH ON CONSOLE. THE MD "RE-ADJUSTED IAB", DETERMINED IT WAS KINKED, AND REPLACED IT WITH A NEW ONE. THE IAB WAS IN USE FOR APPROXIMATELY 53 MINUTES BEFORE REMOVAL. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20022108 ↗
• MalfunctionSep 11, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER TWO DAYS OF INTRA-AORTIC BALLOON (IAB) THERAPY A BALLOON RUPTURE OCCURRED. THE PATIENT WAS TAKEN TO THE CATH LAB TO HAVE A NEW IAB INSERTED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED. REPORTED VIA MEDWATCH # (B)(4): UPON NOTICING AUDIBLE IABP ALARM. L AXILLARY IABP ACCESS SITE NOTED TO HAVE BLOOD ALONG LENGTH OF THE RETURN LINE TUBING. TUBING WAS CLAMPED PROXIMALLY WITH A KELLY CLAMP. IABP WAS TURNED OFF, AND RETURN LINE DISCONNECTED AND PLACED IN A BIOHAZARD BAG FOR APPROPRIATE ANALYSIS. AFTER BLOOD WAS NOTED IN THE IABP TUBING, PUMP WAS TURNED OFF AND CARDIOVASCULAR TEAM NOTIFIED. PATIENT REQUIRED A PROCEDURE TO HAVE THE BALLOON PUMP EXCHANGED. CATH LAB WAS ACTIVATED FOR BALLOON PUMP EXCHANGE. AT THE END OF THE PROCEDURE, GOOD FUNCTION OF THE IABP CATHETER WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17725526 ↗