Linear 7.5Fr. 34cc IAB with Accessories, US Only 0684-00-0479-01URecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10607567109503), received between Oct 9, 2020 and Dec 11, 2025 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (8 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE LINEAR 34CC HAD HIGH PRESSURE ALARM CONTINUED TO GO OFF AFTER INFLATING BALLOON. HAD TO TAKE THIS ONE OUT AND PUT IN A DIFFERENT BALLOON. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777439 ↗
• MalfunctionJan 6, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING IAB THERAPY, EXPERIENCED HIGHER THAN NORMAL AUGMENTATION.

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

  MAUDE report 21080162 ↗
• MalfunctionJan 3, 2025Inability to Auto-Fill; Restricted Flow rate; Air/Gas in Device; Inability to Auto-Fill; Restricted Flow rate; Air/Gas in Device

  IT WAS REPORTED BY CUSTOMER THAT LINEAR 7.5FR. 34CC INTRA-AORTIC BALLOON (IAB) HAD RESTRICTION, GAS GAIN AND AUTOFILL FAILURE ALARMS WERE OCCURRING. ALL ATTEMPTS AT TROUBLESHOOTING WERE UNSUCCESSFUL. THE CUSTOMER STATED THAT THEY HAD REPLACED THE IAB CATHETER AND FOUND A SIGNIFICANT KINK IN THE CATHETER AT THE AXILLARY INSERTION AREA. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21064988 ↗
• MalfunctionJul 2, 2024Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, A GAS LOSS ALARM WAS GENERATED AND AN "IAB RUPTURE" OCCURRED. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. IAB WAS REMOVED AND NO OTHER CONCERNS NOTED. THE IAB WAS IN USE FOR APPROXIMATELY TWO DAYS. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19659240 ↗
• InjuryApr 18, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER TWO TO THREE DAYS OF INTRA-AORTIC BALLOON (IAB) THERAPY, BLOOD WAS NOTED IN THE IAB AFTER THE PATIENT TURNED ONTO HER LEFT SIDE WHEN RETURNED TO SUPINE POSITION. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. THE PATIENT EXPERIENCED IMMEDIATE PAIN AND PARESTHESIA TO LEFT LOWER EXTREMITY. VASCULAR SURGERY WAS CONSULTED AND THE PATIENT WENT TO THE OPERATING ROOM FOR LEFT AXILLARY ARTERY REPAIR AND HEMATOMA REMOVAL.

  Patient problems: Hematoma; Pain; Paresthesia

  MAUDE report 19139903 ↗
• MalfunctionApr 3, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN INTRA-AORTIC BALLOON (IAB) RUPTURE OCCURRED DURING THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19032202 ↗
• InjuryMar 28, 2024

  BLOOD WAS NOTED IN LEFT AXILLARY INTRA-AORTIC BALLOON PUMP (IABP) HELIUM SHEATH AFTER PATIENT TURNED ONTO HER LEFT SIDE. BLOOD FOUND IN THE BALLOON. IMMEDIATE PAIN AND PARESTHESIA TO LEFT LOWER EXTREMITY, VASCULAR SURGERY CONSULTED, PATIENT WENT TO THE OPERATING ROOM FOR LEFT AXILLARY ARTERY REPAIR AND HEMATOMA REMOVAL.

  Patient problems: Hematoma; Pain; Paralysis

  MAUDE report 18989980 ↗
• MalfunctionOct 31, 2023Break; Break

  IT WAS REPORTED DURING INSERTION OF THE INTRA-AORTIC BALLOON (IAB), THE HUB OF THE DILATOR BROKE OFF. THE PHYSICIAN REMOVED THE DILATOR, OPENED ANOTHER IAB PACK, PROCEEDED WITH INSERTION, AND CONTINUED INITIATION OF THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18039189 ↗
• MalfunctionOct 3, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT PRIOR TO INSERTION, A HOLE WAS FOUND WHEN ON THE INTRA-AORTIC BALLOON (IAB) WHEN OPENING THE PACKAGING. 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 17860986 ↗
• MalfunctionSep 8, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN INTRA-AORTIC BALLOON (IAB) RUPTURE HAD OCCURRED WITHIN THE PAST THREE DAYS (B)(6) 2023 -THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17715883 ↗
• MalfunctionAug 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THERAPY, AN INTRA-AORTIC BALLOON (IAB) RUPTURE OCCURRED AND A SURFACE-ENHANCED RAMAN SPECTROSCOPY (SERS) WAS PLACED. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. IT WAS NOTED THAT THE PATIENT HAD MULTIPLE RUPTURES WITH REPLACEMENTS AND AFTER THIS ONE THEY WERE PLACING AN IMPELLA. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED. THIS REPORT IS FOR THE 1ST IAB. A SEPARATE REPORT HAS BEEN SUBMITTED FOR THE 2ND IAB UNDER MFG REPORT NUMBER 2248146-2023-00520. EVENT DESCRIPTION RECEIVED FROM MEDWATCH # (B)(4). IABP RUPTURE. IABP EMERGENTLY REMOVED AND REPLACED. AXILLARY PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17584808 ↗
• MalfunctionAug 7, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A LEAK OCCURRED AFTER LESS THAN 24 HOURS OF INTRA-AORTIC BALLOON (IAB) THERAPY. IT WAS NOTED THAT THE CONSOLE HAD GENERATED A GAS LOSS IN IAB CIRCUIT 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 17469541 ↗
• MalfunctionMay 1, 2023Break; Break

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16844086 ↗
• MalfunctionAug 29, 2022Difficult to Insert; Inappropriate Waveform; Difficult to Insert; Inappropriate Waveform

  IT WAS REPORTED THAT WITHIN MINUTES OF INSERTING THE INTRA-AORTIC BALLOON (IAB), THE CONSOLE GENERATED AN ALARM AND AN ARTERIAL WAVEFORM COULD NOT BE OBTAINED. THE CUSTOMER ALSO NOTED DIFFICULT DURING INSERTION. THE IAB WAS IMMEDIATELY REPLACED WITH A NEW ONE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15314882 ↗
• MalfunctionDec 7, 2021Inflation Problem; Inflation Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12951175 ↗
• MalfunctionDec 2, 2021Inability to Auto-Fill; Inability to Auto-Fill

  IT WAS REPORTED THAT AFTER EIGHT DAYS OF INTRA-AORTIC BALLOON (IAB) THERAPY, THE CONSOLE GENERATED AN IAB CATHETER RESTRICTION ALARM WHICH EVENTUALLY DEVELOPED INTO AN AUTO-FILL FAILURE ALARM. THEY WERE UNABLE TO RESUME PUMPING DUE TO THE CONSTANT ALARMS. THERE WAS NO BLOOD IN THE TUBING AND THERE WERE NO VISIBLE KINKS IN THE CATHETER. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. THE CUSTOMER ATTEMPTED A DECREASE IN AUGMENTATION CONTROL, AND ATTEMPTED PRESSING "IAB FILL" KEY WITHOUT RELIEF. THEY WERE ADVISED TO OBTAIN A CHEST X-RAY TO CHECK THE LOCATION AND CONTACT THE PHYSICIAN FOR FURTHER INSTRUCTION AND POSSIBLE REPLACEMENT/REMOVAL. IT WAS LATER REPORTED THAT THE IAB HAD BEEN REMOVED AND REPLACED WITH A NEW ONE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916046 ↗
• MalfunctionSep 3, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE CONSOLE GENERATED A CHECK CATHETER ALARM. IT WAS ALSO NOTED THAT BLOOD WAS SEEN IN THE HELIUM TUBING. THE IAB WAS REMOVED NOT REPLACED. THE PATIENT WAS STABLE WITHOUT SUPPORT. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12424771 ↗
• MalfunctionAug 31, 2021Difficult to Flush; Difficult to Flush

  THE FOLLOWING WAS REPORTED VIA MEDWATCH REPORT # (B)(4): IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE ARTERIAL LINE OF THE MAQUET (7.5 X 34) WOULD NOT ALLOW FOR FLUSHING, ASPIRATION AND DID NOT GENERATE A WAVEFORM ON THE CONSOLE. THE CONSOLE WAS BEING WEANED TO DETERMINE IF THE PATIENT WAS STABLE ENOUGH FOR THE IAB TO BE REMOVED; THE CONSOLE WAS REMOVED SHORTLY THEREAFTER. THE IAB WAS INSERTED AT A NEIGHBORING HOSPITAL THE DAY BEFORE SO NO PRODUCT INFORMATION, OTHER THAN CATALOG NUMBER, IS AVAILABLE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12392119 ↗
• MalfunctionFeb 17, 2021No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WAS AN INTRA-AORTIC BALLOON (IAB) FAILURE. THE IAB WAS NOT KEPT FOR EVALUATION. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11339777 ↗
• MalfunctionOct 9, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE IAB WOULD NOT FILL. THE CUSTOMER ATTEMPTED USING THE IAB ON THREE DIFFERENT CONSOLES, BUT EACH TIME IT ATTEMPTED TO FILL THE CONSOLE WOULD ALARM AND GO INTO STANDBY MODE. THE CUSTOMER DECIDED TO REPLACE THE IAB WITH A SECOND ONE. UPON OPENING THE STERILE PACKAGING OF THE SECOND IAB, CONDENSATION WAS NOTICED IN THE HELIUM TUBING. A THIRD IAB WAS THEN USED AND THERAPY WAS CONTINUED SUCCESSFULLY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED. THIS REPORT IS FOR THE 2ND IAB USED IN THIS EVENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE 1ST IAB USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10655427 ↗
• MalfunctionOct 9, 2020Filling Problem; Filling Problem

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE IAB WOULD NOT FILL. THE CUSTOMER ATTEMPTED USING THE IAB ON THREE DIFFERENT CONSOLES, BUT EACH TIME IT ATTEMPTED TO FILL THE CONSOLE WOULD ALARM AND GO INTO STANDBY MODE. THE CUSTOMER DECIDED TO REPLACE THE IAB WITH A SECOND ONE. UPON OPENING THE STERILE PACKAGING OF THE SECOND IAB, CONDENSATION WAS NOTICED IN THE HELIUM TUBING. A THIRD IAB WAS THEN USED AND THERAPY WAS CONTINUED SUCCESSFULLY. 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 USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10655357 ↗