Linear 7.5Fr. 34cc IAB (China) 0684-00-0479-01CRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10607567109329), received between Feb 12, 2021 and Mar 25, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 reports).

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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2025Difficult to Insert; Difficult to Insert

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21685680 ↗
• MalfunctionNov 14, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) COULD NOT BE INSERTED THROUGH THE SHEATH. A NEW IAB WAS INSERTED SUCCESSFULLY TO CONTINUE WITH THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130830 ↗
• MalfunctionNov 2, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER ABOUT TWO HOURS OF INTRA-AORTIC BALLOON (IAB) THERAPY, BLOOD WAS FOUND IN THE TUBING. THE CATHETER WAS REMOVED AND NOT REPLACED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057447 ↗
• MalfunctionApr 10, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING INSERTION OF THE INTRA-AORTIC BALLOON (IAB), BLOOD WAS FOUND IN THE TUBING. 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 16707969 ↗
• MalfunctionJan 11, 2023Inability to Auto-Fill; Inability to Auto-Fill

  IT WAS REPORTED THAT AFTER INSERTING THE INTRA-AORTIC BALLOON (IAB) AND INITIATING THERAPY, THE CONSOLE GENERATED AN AUTOFILL FAILURE ALARM. 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 16141587 ↗
• MalfunctionAug 31, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CUSTOMER COULD NOT REMOVE THE INTRA-AORTIC BALLOON (IAB) FROM THE T-HANDLE. A NEW IAB WAS INSERTED SUCCESSFULLY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331346 ↗
• MalfunctionAug 16, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER APPROXIMATELY 11 HOURS OF INTRA-AORTIC BALLOON (IAB) THERAPY THE CONSOLE GENERATED A LEAK IN IAB CIRCUIT ALARM. BLOOD WAS THEN FOUND IN THE TUBING. A NEW IAB WAS INSERTED TO CONTINUE THERAPY WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15234809 ↗
• MalfunctionApr 13, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT PRIOR TO INSERTING THE INTRA-AORTIC BALLOON (IAB) THE CUSTOMER NOTICED THAT THE TOP OF THE GUIDEWIRE WAS DAMAGED AND IT COULD NOT BE INSERTED. A NEW IAB WAS INSERTED INSTEAD. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14106886 ↗
• MalfunctionApr 6, 2022Leak/Splash; Difficult to Remove; Leak/Splash; Difficult to Remove

  IT WAS REPORTED THAT AFTER APPROXIMATELY TWO DAYS OF INTRA-AORTIC BALLOON (IAB) THERAPY THE CONSOLE GENERATED A CHECK IAB CATHETER ALARM. THE CUSTOMER CHECKED THE IAB BUT FOUND NO ISSUE. TWO HOURS LATER, THE CONSOLE GENERATED THE SAME ALARM AND BLOOD WAS SEEN IN THE TUBING. THE IAB HAD TO BE REMOVED BY SURGERY IN THE INTENSIVE CARE UNIT (ICU). THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14022386 ↗
• MalfunctionFeb 4, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER 2 DAYS OF INTRA-AORTIC BALLOON(IAB) THERAPY, BLOOD WAS SEEN IN THE TUBING. THE IAB WAS REMOVED AND LUMEN WAS FOUND TO BE BROKEN. THERE WAS NO REPORTED INJURY OR ADVERSE EVENT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13457469 ↗
• MalfunctionJan 7, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER ABOUT 8 HOURS OF INTRA-AORTIC BALLOON(IAB) THERAPY, BLOOD WAS SEEN IN THE TUBING. THE BALLOON WAS REMOVED AND REPLACED WITH A NEW ONE. THERE WAS NO REPORTED INJURY OR ADVERSE EVENT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13195149 ↗
• MalfunctionDec 6, 2021Difficult to Remove; Difficult to Remove

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12942409 ↗
• MalfunctionNov 22, 2021Difficult to Insert; Difficult to Insert

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12852361 ↗
• MalfunctionNov 22, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE GUIDEWIRE WAS INSERTED SMOOTHLY, BUT THE INTRA-AORTIC BALLOON (IAB) COULD NOT BE INSERTED. A NEW IAB WAS INSERTED, HOWEVER, THE SAME ISSUE OCCURRED. A THIRD IAB WAS INSERTED SUCCESSFULLY TO CONTINUE THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED. THIS REPORT IS FOR THE SECOND IAB USED IN THIS EVENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE FIRST IAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12852356 ↗
• MalfunctionNov 1, 2021Use of Device Problem; Use of Device Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12728061 ↗
• MalfunctionFeb 12, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER APPROXIMATELY 17 HOURS OF INTRA-AORTIC BALLOON (IAB) THERAPY, BLOOD WAS FOUND IN THE TUBING. THE IAB WAS REMOVED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

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

  MAUDE report 11320801 ↗