MEGA 8Fr. 50cc IAB (with Statlock & APA) 0684-00-0296-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10607567108018), received between Feb 24, 2021 and Feb 6, 2026 — classified as 14 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-2220-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Leak/Splash; Material Rupture

  IT WAS REPORTED THAT INTRA AORTIC BALLOON HAD BALLOON RUPTURE. NO ALARMS PRIOR TO RUPTURE. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24276436 ↗
• MalfunctionSep 19, 2025Restricted Flow rate; Material Deformation; Restricted Flow rate; Material Deformation

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093597 ↗
• MalfunctionSep 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 2 INTRA-AORTIC BALLOONS (IAB) 50CC MEGA HAD RUPTURE DURING INSERTION THROUGH THE SHEATH. BOTH WERE FROM THE SAME LOT THEY THEN USED A BALLOON WITH A DIFFERENT LOT SAME SHEATH AND DID NOT HAVE ANY ISSUES. THERE WAS NO HARM TO PATIENT. THERE WAS A 20 MIN DELAY BASED ON THE FAILURE OF THE FIRST 2 INSERTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22990456 ↗
• MalfunctionAug 6, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED BY CUSTOMER THAT DURING INTRA AORTIC BALLOON (IAB) THERAPY THERE WAS AN ISSUE WITH THE ARTERIAL LINE QUALITY. THE CUSTOMER WAS ABLE TO ASPIRATE SEVERAL CCS OF BLOOD FROM THE INNER LUMEN OF THE BALLOON, HOWEVER, STATED THAT SHE COULD NOT FLUSH THE LINE. THE ARTERIAL LINE TUBING HAD A FEW ¿EXTRA PIECES ON THE A-LINE TUBING, INCLUDING A LONG EXTENSION PIECE AND AN EXTRA STOCK COCK¿. CUSTOMER REMOVED THESE PIECES AND ATTEMPTED TO FLUSH AGAIN, WHICH WAS UNSUCCESSFUL. NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727847 ↗
• MalfunctionJun 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 2 INTRA-AORTIC BALLOONS (IAB) 50CC MEGA HAD RUPTURE DURING INSERTION THROUGH THE SHEATH. BOTH WERE FROM THE SAME LOT THEY THEN USED A BALLOON WITH A DIFFERENT LOT SAME SHEATH AND DID NOT HAVE ANY ISSUES. THERE WAS NO HARM TO PATIENT. THERE WAS A 20 MIN DELAY BASED ON THE FAILURE OF THE FIRST 2 INSERTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22172972 ↗
• MalfunctionMay 8, 2025Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT DURING INTRA AORTIC BALLOON THERAPY, THE CATHETER WAS DAMAGED AND UNABLE TO CROSS PROPERLY. THERE WAS NO HARM OR INJURY REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21982907 ↗
• MalfunctionNov 7, 2024Difficult to Insert; Difficult to Insert

  DURING THE PLACEMENT OF THE INTRA-AORTIC BALLOON (IAB), THE GUIDEWIRE WAS BENT. THE GUIDEWIRE FROM ANOTHER IAB WAS USED, WHICH ALSO BENT. A SPARE GUIDEWIRE WAS THEN USED, WHICH ALLOWED THE BALLOON TO BE PLACED. THIS REPORT IS FOR THE 2ND PRODUCT USED IN THIS EVENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE 1STPRODUCT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20635035 ↗
• MalfunctionJan 23, 2023Leak/Splash; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16227878 ↗
• MalfunctionNov 1, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER APPROXIMATELY FIVE HOURS OF INTRA-AORTIC BALLOON (IAB) THERAPY, BLOOD WAS NOTICED IN THE EXTRACORPOREAL TUBING. IT IS UNKNOWN IF ANY ALARMS WERE GENERATED. THE INSERTION WAS REPORTED TO BE LEFT AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. THE IAB WAS REMOVED 10 MINUTES LATER. A NEW IAB WAS INSERTED VIA RIGHT AXILLARY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15709772 ↗
• MalfunctionJun 15, 2022Leak/Splash; Inappropriate Waveform; Gas/Air Leak; Leak/Splash; Inappropriate Waveform; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT HAD BEEN TRANSFERRED FROM ANOTHER FACILITY WITH AN IMPELLA DEVICE INSERTED IN THE LEFT GROIN. THE IMPELLA DEVICE WAS REMOVED DUE TO LEFT LOWER LEG ISCHEMIA (SUBSEQUENT REPAIR OF LEFT FEMORAL ARTERY). THE CUSTOMER ATTEMPTED TO INSERT ANOTHER IMPELLA DEVICE IN THE RIGHT AXILLARY BUT THIS WAS UNSUCCESSFUL DUE TO A TORTUOUS AORTA. THE CUSTOMER THEN INSERTED A MAQUET INTRA-AORTIC BALLOON (IAB). THE INSERTION WAS REPORTED TO BE RIGHT AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. AFTER INSERTION OF THE IAB, THE WAVEFORM WAS DAMPENED. APPROXIMATELY FOUR HOURS LATER, THE WAVEFORM WAS FLAT. APPROXIMATELY THREE AND A HALF HOURS AFTER THAT, BLOOD WAS SEEN IN THE TUBING. IT WAS NOTED THAT THE CONSOLE HAD GENERATED A GAS LOSS IN IAB CIRCUIT ALARM ON SEVERAL OCCASIONS. THE IAB WAS REMOVED SOON AFTER THE BLOOD WAS NOTICED. THE PATIENT WAS EXTUBATED AND PROGRESSING AFTER THERAPY WAS CONCLUDED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14701430 ↗
• MalfunctionFeb 14, 2022Leak/Splash; Difficult to Remove; Leak/Splash; Difficult to Remove

  N/A.

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

  MAUDE report 13523594 ↗
• MalfunctionFeb 2, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING INSERTION OF THE INTRA-AORTIC BALLOON (IAB), THE BALLOON WOULD NOT PROGRESS THROUGH SHEATH AND ARTERY EVEN AFTER SEVERAL ATTEMPTS. A NEW BALLOON WAS OPENED AND PROGRESSED WITHOUT PROBLEM. THERE WAS NO REPORTED INJURY OR ADVERSE EVENT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13428772 ↗
• MalfunctionFeb 24, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER HAD TWO INTRA-AORTIC BALLOONS (IAB) THAT HAD MALFUNCTIONED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11371958 ↗
• MalfunctionFeb 24, 2021No Apparent Adverse Event; No Apparent Adverse Event

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11371898 ↗