Linear 7.5Fr. 40cc IAB (INDIA) 0684-00-0480-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10607567109718), received between Sep 1, 2020 and Sep 22, 2026 — classified as 2 deaths, 61 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (29 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-2223-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Leak/Splash

  It was reported that after insertion of Linear 40cc balloon catheter the machine was not functioning, and a leak was observed in the gas line. Another catheter was used to resume the therapy. No harm to the patient reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50851936 ↗
• MalfunctionApr 4, 2026Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH BALOON CATHETER LINEAR 40CC. A KINK WAS OBSERVED AT THE JUNCTION OF THE IAB CATHETER, PREVENTING GUIDEWIRE PASSAGE DESPITE MULTIPLE ATTEMPTS. A NEW BALLOON WAS INSERTED INTO THE PATIENT. NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24785044 ↗
• MalfunctionMar 12, 2026Break; Leak/Splash; Material Rupture

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577221 ↗
• MalfunctionMar 9, 2026Break

  IT WAS REPORTED THAT A CRACK OR DAMAGE WAS OBSERVED AT THE PRESSURE MONITORING SITE OF A LINEAR 40 CC CATHETER. THE ISSUE WAS IDENTIFIED PRIOR TO BALLOON INSERTION, AND THE CATHETER WAS NOT USED. NO HARM OR INJURY TO THE PATIENT OCCURRED, AND THE PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24551512 ↗
• MalfunctionJan 14, 2026Inability to Auto-Fill; Fluid/Blood Leak; Inflation Problem; Material Rupture

  IT WAS REPORTED BY CUSTOMER THAT DURING USE, THE LINEAR 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) WAS RAPTURED AND BALLOON DID NOT INFLATE. THERE WAS BLOOD IN THE TUBING AND CONSOLE HAD AN AUTOFILL FAILURE ALARM. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24065860 ↗
• MalfunctionDec 8, 2025Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED BYB CUSTOMER THAT DURING INSERTION OF INTRA AORTIC BALLOON, THERE WAS A CARDIOGENIC SHOCK & SINUS RHYTHM. THE PATIENT WAS IN MEDICAL MANAGEMENT IN CCU WHEN WE WERE TRYING TO PUT IABC - 40CC INTO SHEATH IT WAS VERY DIFFICULT TO INSERT THROUGH SHEATH DUE TO THE KINK. ANOTHER IABC WAS INSERTED. NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23738501 ↗
• MalfunctionNov 21, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING USE, INTRA-AORTIC BALLOON (IAB) SUCKED UP IN THE SHEATH AND COULD NOT MOVED FORWARD AND BACKWARD. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617059 ↗
• MalfunctionOct 23, 2025Pacing Inadequately; Pacing Inadequately

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372657 ↗
• MalfunctionFeb 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER 0.5 HOURS OF INTRA-AORTIC BALLOON (IAB) THERAPY, THERE WAS A BALLOON LEAKING ALARM IN UNIT AND BLOOD DETECTED IN THE CATHETER AND TUBING. THE IAB WAS REMOVED AFTER 0.5 HOURS OF USE.THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394353 ↗
• MalfunctionJan 30, 2025Fluid/Blood Leak; Appropriate Device Problem Term/Code Not Available; Fluid/Blood Leak; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT BLOOD WAS OBSERVED IN THE CATHETER OF THE INTRA-AORTIC BALLOON (IAB). NO HARM OR INJURY WAS REPORTED.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272052 ↗
• MalfunctionNov 13, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO INSERT THE INTRA-AORTIC BALLOON (IAB) OVER THE GUIDEWIRE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20676377 ↗
• MalfunctionOct 23, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER 21 HOURS OF INTRA-AORTIC BALLOON (IAB) THERAPY, BLOOD WAS SEEPING IN THROUGH THE RETURN VALVE INTO THE SLEEVE. THE IAB WAS REMOVED AFTER 29 HOURS OF USE. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515073 ↗
• MalfunctionSep 9, 2024Difficult to Insert; Material Deformation; Material Twisted/Bent; Difficult to Insert; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT INTRA-AORTIC BALLOON (IAB) THERAPY WAS INDICATED POST-SURGERY AS THE PATIENT WAS HEMODYNAMICALLY UNSTABLE. DURING INSERTION, IT WAS NOTED THAT THE GUIDEWIRE WAS BENT AND THE IAB BECAME KINKED. THE IAB WAS UNABLE TO BE INSERTED. AS THE PATIENT'S BLOOD PRESSURE WAS DETERIORATING, A NEW IAB WAS THEN INSERTED TO PROVIDE THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171450 ↗
• MalfunctionJul 22, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19793329 ↗
• MalfunctionJun 26, 2024Inflation Problem; Leak/Splash; Insufficient Device Problem Information; Inflation Problem; Leak/Splash; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER THREE DAYS OF THERAPY, THE INTRA-AORTIC BALLOON (IAB) DID NOT INFLATE PROPERLY AND BLOOD WAS FOUND IN THE IAB. IT WAS ALSO NOTED THAT AN ALARM WAS GENERATED AND PUMPING STOPPED. A NEW IAB WAS INSERTED TO CONTINUE THERAPY FOR ANOTHER TWO DAYS. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19616848 ↗
• MalfunctionJun 24, 2024Difficult to Insert; Difficult to Insert

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19593071 ↗
• MalfunctionMay 6, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE BALLOON WOULD NOT INFLATE. BLOOD WAS SEEN IN THE STAT-GARD SLEEVE. 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 19247649 ↗
• MalfunctionJan 31, 2024Pressure Problem; Pressure Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18615162 ↗
• MalfunctionJan 8, 2024Difficult to Insert; Difficult to Insert

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466104 ↗
• MalfunctionJan 2, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER APPROXIMATELY 30 HOURS OF INTRA-AORTIC BALLOON (IAB) THERAPY, BLOOD WAS SEEN INSIDE 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 18430872 ↗
• MalfunctionDec 27, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY A LEAK OCCURRED AND BLOOD WAS SEEN. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18407287 ↗
• MalfunctionAug 28, 2023Suction Problem; Pressure Problem; Suction Problem; Pressure Problem

  IT WAS REPORTED AFTER INSERTION, THE INTRA-AORTIC BALLOON (IAB) WAS UNABLE TO BE ASPIRATED AND PRESSURE READINGS COULD NOT BE OBTAINED. IT WAS ALSO NOTED THAT THE CONSOLE HAD GENERATED AN ALARM WITH ECG TRIGGER. THE IAB WAS CHECKED TWICE BUT THE ISSUE WOULD NOT RESOLVE. WITHIN 30 MINUTES, A NEW IAB WAS INSERTED TO CONTINUE WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17633458 ↗
• MalfunctionJul 6, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER APPROXIMATELY NINE HOURS AND 45 MINUTES OF INTRA-AORTIC BALLOON (IAB) THERAPY, CONSOLE GENERATED A CHECK IAB CATHETER ALARM. THE CUSTOMER SECURED ALL THE CONNECTIONS. AFTER 10 MINUTES, THE SAME ALARM WAS GENERATED. WHEN THEY WENT TO CHECK THE IAB INSERTION SITE, BLOOD APPEARED IN THE GAS LINE. THEY WERE TOLD TO REMOVE THE IAB IMMEDIATELY BY THE SURGEON. AFTER THEY REMOVED THE IAB, THEY KEPT IT IN WATER AND FLUSHED IT WITH AIR. THERE WAS A HOLE NEAR THE DISTAL END OF THE IAB. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17270056 ↗
• MalfunctionJan 3, 2023Leak/Splash; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16087518 ↗
• DeathNov 17, 2022Material Deformation; Pressure Problem; Material Deformation; Pressure Problem

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE AUGMENTATION PRESSURE DISPLAYED ON THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS ABNORMAL. THE CUSTOMER OBSERVED INACCURATE PRESSURE READING WHICH RESULTED TO LESS AUGMENTATION. IT WAS EXPLAINED THAT THE ISSUE WAS SUSPECTED TO BE DUE TO A BAD PRESSURE TRANSDUCER, BLOCKAGE IN INNER LUMEN, AND A KINK IN IAB. THE CUSTOMER REPORTED THAT THE PATIENT EXPIRED. THIS REPORT IS FOR THE IAB. A SEPARATE REPORT FOR THE CARDIOSAVE IABP HAS BEEN SUBMITTED UNDER MFG REPORT NUMBER - 2249723-2022-02862.

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

  MAUDE report 15813806 ↗