Linear 7.5Fr. 34cc IAB (INDIA) 0684-00-0479-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10607567109695), received between Nov 3, 2020 and Aug 10, 2026 — classified as 1 death, 43 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (14 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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Fluid/Blood Leak; Material Rupture

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50191620 ↗
• MalfunctionJan 23, 2026Pressure Problem

  IT WAS REPORTED THAT LINEAR 7.5FR. 34CC INTRA AORTIC BALLOON PUMP (IABP) HAD FAILURE IN BALLOON AUGMENTATION. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159210 ↗
• MalfunctionJan 6, 2026Inflation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE INTRA-AORTIC BALLOON (IAB) 34CC IAB CATHETER FAILED TO INFLATE, ALONG WITH THIS RECEIVED CONTINUOUS ALARM AS CHECK IAB CATHETER. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973224 ↗
• MalfunctionDec 27, 2025Obstruction of Flow; Obstruction of Flow

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23901442 ↗
• MalfunctionNov 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING PROCEDURE JUST BEFORE TIP OF THE BALLOON IS DEFORMED AND BENT WHICH WAS INSERTION TRIED, BUT IT DID NOT PASS INSIDE THE ARTERY. PATIENT WAS INVOLVED. NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23530057 ↗
• MalfunctionOct 10, 2025Pressure Problem; Pressure Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23265100 ↗
• MalfunctionSep 5, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED DURING INTRA-AORTIC BALLOON THERAPY CATHETER DID NOT INFLATE. NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976349 ↗
• MalfunctionJun 13, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON PUMP (IAB) HAD LEAKAGE OF GAS.

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

  MAUDE report 22202053 ↗
• MalfunctionJan 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 21205882 ↗
• MalfunctionOct 29, 2024Gas/Air Leak; Gas/Air Leak

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559901 ↗
• MalfunctionOct 23, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE PUMP HAD INITIAL FUNCTION WITH GOOD AUGMENTATION FOR 8 TO 10 MIN. THEN IT SHOWED SUDDEN IAB INFLATION FAILURE AND BLOOD IN CATHETER. 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 20517148 ↗
• MalfunctionOct 17, 2024Leak/Splash; Leak/Splash

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20477356 ↗
• MalfunctionOct 16, 2024Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT WHILE INSERTING THE SHEATH, THE CUSTOMER NOTICED THAT BLOOD WAS ESCAPING INTO THE LUMEN OF THE INTRA-AORTIC BALLOON (IAB) AND BLEEDING OUTSIDE. A SECOND IAB WAS INSERTED AND THE SAME ISSUE OCCURRED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED. THIS REPORT IS FOR THE 1ST IAB USED IN THIS EVENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE 2ND IAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20465996 ↗
• MalfunctionJun 11, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED DURING CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. THE PATIENT WAS NOTED TO BE CRITICAL AT THE TIME OF THE EVENT. THE GUIDEWIRE CROSSED THE FEMORAL ARTERY, THEN THE GUIDEWIRE TRIED TO CROSS THE IAB BUT IT COULD NOT. A NEW IAB WAS INSERTED TO PROVIDE THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509799 ↗
• MalfunctionApr 22, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT WHEN THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED, IT WOULD NOT INFLATE. A NEW IAB WAS INSERTED TO PROVIDE THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153972 ↗
• MalfunctionMar 7, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE DISTAL END OF THE BALLOON WOULD NOT INFLATE. THE IAB WAS REPLACED AND THERAPY WAS PROVIDED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18855407 ↗
• MalfunctionMar 7, 2024Inflation Problem; Inflation Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18855405 ↗
• MalfunctionNov 8, 2023Inflation Problem; Inflation Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18092444 ↗
• MalfunctionOct 31, 2023Leak/Splash; Difficult to Remove; Leak/Splash; Difficult to Remove

  IT WAS REPORTED THAT AFTER 63 HOURS OF INTRA-AORTIC BALLOON (IAB) THERAPY, BLOOD PARTICLES WERE SEEN INSIDE THE IAB. IT WAS ALSO NOTED THAT BLOOD HAD ENTERED THE PUMP. THE IAB WAS THEN REMOVED, THOUGH, THIS ISSUE CAUSED DIFFICULTY WITH REMOVAL. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED. THIS REPORT IS FOR THE IAB INVOLVED IN THIS EVENT. A SEPARATE REPORT HAS BEEN SUBMITTED FOR THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNDER MFG REPORT NUMBER 2249723-2023-04768.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18039768 ↗
• MalfunctionJul 24, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BLOOD BEGAN COLLECTING IN THE INTRA-AORTIC BALLOON (IAB) AFTER INSERTING IT 5-7 CM. 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 17377085 ↗
• MalfunctionJul 12, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) COULD NOT BE INSERTED THROUGH THE PROVIDED SHEATH AND INTRODUCER DESPITE MULTIPLE ATTEMPTS. A NEW IAB WAS SUCCESSFULLY INSERTED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17309909 ↗
• MalfunctionMar 22, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER INSERTING THE INTRA-AORTIC BALLOON (IAB) A LEAK OCCURRED. 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 16591242 ↗
• MalfunctionFeb 9, 2023Inflation Problem; Inflation Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16334759 ↗
• MalfunctionNov 22, 2022Difficult to Insert; Leak/Splash; Difficult to Insert; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15845790 ↗
• MalfunctionOct 18, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, A LEAK OCCURRED. 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 15625074 ↗