Linear 7.5Fr. 40cc IAB (China) 0684-00-0480-01CRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10607567109343), received between Aug 26, 2020 and Feb 17, 2026 — classified as 1 death, 31 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (18 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Inflation Problem; Unraveled Material

  IT WAS REPORTED BY THE CUSTOMER THAT DURING THE INSERT OF INTRA-AORTIC BALLOON (IAB) CATHETER, FOUND THE IAB CAN NOT FULLY INFLATION. THERE WAS NO PATIENT HARM OR INJURY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367766 ↗
• MalfunctionNov 26, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654082 ↗
• MalfunctionSep 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23082147 ↗
• MalfunctionJan 10, 2025Inflation Problem; Inflation Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21121870 ↗
• DeathSep 27, 2024Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH ACUTE MYOCARDIAL INFARCTION (AMI) AND AN INTRA-AORTIC BALLOON (IAB) WAS IMMEDIATELY INSERTED. WHEN CONNECTED TO THE PUMP, AN UNKNOWN ALARM WAS GENERATED. IT WAS NOTED THAT THE BLOOD PRESSURE (BP) DISPLAYED BY THE PUMP WAS VERY DIFFERENT FROM THAT OF THE BEDSIDE MONITOR. THE PHYSICIAN IMMEDIATELY INSERTED A NEW IAB, BUT THEY THOUGHT THE BEST TIME FOR TREATMENT WAS MISSED. THE PATIENT REMAINED IN THE ICU. THE PATIENT PASSED AWAY TWO DAYS LATER.

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

  MAUDE report 20318534 ↗
• MalfunctionSep 23, 2024Inflation Problem; Inflation Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20280661 ↗
• MalfunctionSep 23, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AFTER INSERTION, THE INTRA-AORTIC BALLOON (IAB) WOULD NOT FULLY INFLATE. THE IAB WAS REMOVED IMMEDIATELY. A NEW IAB WAS INSERTED, BUT THE SAME ISSUE OCCURRED. A THIRD IAB WAS NOT INSERTED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED. THIS REPORT IS FOR THE 2ND IAB INVOLVED IN THIS EVENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE 1ST IAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20280600 ↗
• MalfunctionFeb 21, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING INSERTION, THE GUIDEWIRE COULD NOT BE PASSED THROUGH THE INTRA-AORTIC BALLOON (IAB). UPON INSPECTION, A DEPRESSION WAS FOUND ON THE IAB 10 CENTIMETERS FROM THE TIP. THERE WAS NO DAMAGE NOTED TO THE IAB PACKAGING. A NEW IAB WAS INSERTED SUCCESSFULLY 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 18753923 ↗
• MalfunctionOct 16, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER APPROXIMATELY 45 HOURS OF INTRA-AORTIC BALLOON (IAB) THERAPY, THE PUMP GENERATED A FREQUENT ALARM. BLOOD WAS SEEN IN THE TUBING. THE IAB WAS THEN REMOVED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17942335 ↗
• MalfunctionOct 4, 2023Break; Break

  IT WAS REPORTED THAT THE CUSTOMER INSERTED THE GUIDEWIRE SMOOTHLY, HOWEVER, THE INTRA-AORTIC BALLOON (IAB) COULD NOT BE INSERTED COMPLETELY. THE IAB WAS CHECKED AND IT WAS FOUND THAT THE INNER LUMEN WAS COMPLETELY SEPARATED FROM IAB BASE. THEY DID NOT CONTINUE WITH THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17869569 ↗
• MalfunctionNov 28, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER APPROXIMATELY TWO HOURS OF INTRA-AORTIC BALLOON (IAB) THERAPY, BLOOD WAS FOUND IN THE TUBING. THE IAB WAS IMMEDIATELY REMOVED AND IT WAS FOUND THAT THE INNER LUMEN WAS BROKEN. THE CUSTOMER INSERTED A NEW IAB TO CONTINUE THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15871225 ↗
• MalfunctionSep 27, 2022Leak/Splash; Leak/Splash

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15490851 ↗
• MalfunctionAug 30, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AFTER INSERTING THE INTRA-AORTIC BALLOON (IAB) AND INITIATING THERAPY, THE CUSTOMER FOUND THE IAB WOULD NOT INFLATE. THEY THEN PULLED OUT THE IAB AND REPLACED IT WITH A NEW ONE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15322977 ↗
• MalfunctionAug 24, 2022Difficult to Insert; Leak/Splash; Difficult to Insert; Leak/Splash

  IT WAS REPORTED THAT THERE WAS RESISTANCE WHILE INSERTING THE INTRA-AORTIC BALLOON (IAB) AND BLOOD WAS FOUND IN THE IAB. THEY THEN PULLED OUT THE IAB AND INSERTED A NEW ONE WITHOUT FURTHER ISSUES. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15282226 ↗
• MalfunctionAug 16, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT WHEN THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED AND THE CONSOLE WAS STARTED, THE IAB WOULD NOT INFLATE AND A CHECK IAB CATHETER ALARM WAS GENERATED. 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 15234415 ↗
• MalfunctionApr 6, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER APPROXIMATELY THREE DAYS OF INTRA-AORTIC BALLOON (IAB) THERAPY THE CONSOLE GENERATED A RAPID GAS LOSS ALARM. BLOOD WAS SEEN IN THE TUBING. THE IAB WAS REMOVED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14022263 ↗
• MalfunctionApr 4, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER APPROXIMATELY ONE HOUR OF INTRA-AORTIC BALLOON (IAB) THERAPY BLOOD WAS SEEN IN THE TUBING. THE IAB WAS REMOVED AND REPLACED WITH A NEW ONE TO CONTINUE THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13998513 ↗
• MalfunctionFeb 4, 2022Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13450953 ↗
• MalfunctionDec 31, 2021Inability to Auto-Fill; Inability to Auto-Fill

  IT WAS REPORTED THAT AFTER INSERTING AND CONNECTING THE INTRA-AORTIC BALLOON (IAB), THE CONSOLE GENERATED AN AUTO-FILL FAILURE ALARM. THE CUSTOMER CHANGED THE CATHETER EXTENDER FOR A NEW ONE AND THERAPY WAS CONTINUED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13130204 ↗
• MalfunctionDec 14, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) HAD BEEN INSERTED SMOOTHLY. HOWEVER, AFTER APPROXIMATELY ONE DAY OF THERAPY, THE CONSOLE GENERATED A BLOOD DETECTED ALARM AND BLOOD WAS FOUND IN THE TUBING. THE IAB WAS THEN REMOVED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13005548 ↗
• MalfunctionDec 14, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED SMOOTHLY. AFTER 43 HOURS OF THERAPY, BLOOD WAS SEEN IN THE TUBING AND THE IAB WAS REMOVED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003000 ↗
• MalfunctionDec 6, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT AFTER APPROXIMATELY TWO HOURS OF INTRA-AORTIC BALLOON (IAB), THE CONSOLE GENERATED AN UNABLE TO UPDATE TIMING ALARM. THE IAB WAS REMOVED. THE PATIENT WAS STABLE SO ANOTHER IAB WAS NOT INSERTED. THE PATIENT WAS TREATED WITH MEDICATION. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12934244 ↗
• MalfunctionDec 6, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER APPROXIMATELY 45 HOURS OF INTRA-AORTIC BALLOON (IAB) THERAPY, BLOOD WAS SEEN IN THE TUBING. THE IAB WAS REMOVED AND MEDICATION THERAPY WAS USED TO TREAT THE PATIENT. TWO DAYS LATER, A NEW IAB WAS INSERTED. AFTER APPROXIMATELY 58 HOURS OF IAB THERAPY WITH THE SECOND IAB, BLOOD WAS SEEN IN THE TUBING. THE IAB WAS REMOVED AND MEDICATION TREATMENT WAS CONTINUED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED. THIS REPORT IS FOR THE SECOND IAB USED. A SEPARATE REPORT WILL BE SUBMITTED FOR THE FIRST IAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12934026 ↗
• MalfunctionDec 6, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER APPROXIMATELY 45 HOURS OF INTRA-AORTIC BALLOON (IAB) THERAPY, BLOOD WAS SEEN IN THE TUBING. THE IAB WAS REMOVED AND MEDICATION THERAPY WAS USED TO TREAT THE PATIENT. TWO DAYS LATER, A NEW IAB WAS INSERTED. AFTER APPROXIMATELY 58 HOURS OF IAB THERAPY WITH THE SECOND IAB, BLOOD WAS SEEN IN THE TUBING. THE IAB WAS REMOVED AND MEDICATION TREATMENT WAS CONTINUED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED. THIS REPORT IS FOR THE FIRST IAB USED. A SEPARATE REPORT WILL BE SUBMITTED FOR THE SECOND IAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12934020 ↗
• MalfunctionNov 30, 2021Leak/Splash; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12892671 ↗