Linear 7.5Fr. 40cc IAB (with APA) 0684-00-0480-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10607567106571), received between Mar 24, 2021 and Jul 10, 2026 — classified as 1 death, 1 injury, 24 malfunctions.

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

2 FDA recall records name this device's identifier, 2 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 ↗

2. Aug 5, 2022Class IIOpen, Classified

   The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamically unstable.

   Z-0131-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• DeathJul 10, 2026Difficult to Remove

  DURING A SURGICAL PROCEDURE, A LINEAR 40CC INTRA-AORTIC BALLOON (IAB) CATHETER COULD NOT BE ADVANCED THROUGH THE INTRODUCER DUE TO AN INABILITY TO PASS THE DEVICE. DUE TO THE PATIENT'S HEMODYNAMIC CONDITION, AN ALTERNATIVE METHOD OF PLACEMENT WAS PERFORMED. DURING SUBSEQUENT DEVICE REMOVAL, A FEMORAL VASCULAR INJURY OCCURRED, RESULTING IN HEMORRHAGE. SURGICAL INTERVENTION WAS REQUIRED TO REPAIR THE VESSEL AND MANAGE THE BLEEDING. PATIENT DECEASED. ACCORDING TO THE REPORT, DEATH IS NOT ATTRIBUTED TO THE REPORTED EVENT AT THIS STAGE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Unspecified Vascular Problem

  MAUDE report 25776360 ↗
• MalfunctionMar 20, 2026Pacing Problem; Obstruction of Flow

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647280 ↗
• MalfunctionFeb 23, 2026Obstruction of Flow; Inappropriate Waveform

  (B)(6), A CCU RN, CALLED INTO EMERGENCY SUPPORT PROGRAM LINE TO REQUESTING ASSISTANCE FOR TROUBLESHOOTING AN ARTERIAL WAVEFORM THAT HAD A FLAT LINE. HE REPORTED THE FLAT LINE HAD BEEN READING APPROPRIATE HEMODYNAMIC NUMBERS AND PREVIOUSLY HAD AN APPROPRIATE AP WAVEFORM. (B)(6) STATED THEY HAD TROUBLESHOT THE ARTERIAL WAVEFORM QUALITY BY ATTEMPTING TO RE-ZERO THE ARTERIAL LINE AND HAD FLUSHED IT MULTIPLE TIMES. ANOTHER TEAM MEMBER STATED SHE HAD ASPIRATED WITHOUT DIFFICULTY. ESP TEAM ATTEMPTED TO GET CLARIFICATION ON THEIR TROUBLESHOOTING STEPS, HOWEVER (B)(6) STATED THAT THE PHYSICIAN WAS AT THE BEDSIDE, AND HE SAID WE WERE GOOD WITHOUT AN ARTERIAL WAVEFORM.¿ ESP TEAM ATTEMPTED TO EXPLAIN THE IMPORTANCE OF AN ARTERIAL WAVEFORM, BUT A FEMALE VOICE CAME ON THE PHONE AND STATED THAT THEY HAD A MAP ON THE BEDSIDE MONITOR THAT WAS GOOD, SO THEY SHOULD BE FINE¿. ESP TEAM EXPLAINED TO (B)(6) AND THE OTHER TEAM MEMBER THE IMPORTANCE OF THE ARTERIAL WAVEFORM ON THE IABP. ESP TEAM RECEIVED SECOND CALL. (B)(6), A PY1 RESIDENT AND (B)(6) AN ICU RN, INTO EMERGENCY SUPPORT PROGRAM LINE TO REQUESTING ASSISTANCE WITH A BLANK SCREEN ON THE CS300. SHE STATED THAT IT HAD JUST TURNED OFF, AND WE TURNE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414434 ↗
• MalfunctionFeb 10, 2026Break; Fluid/Blood Leak; Leak/Splash; Material Deformation; Material Integrity Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24302906 ↗
• MalfunctionFeb 3, 2026Inability to Auto-Fill; Migration

  NONE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24244167 ↗
• MalfunctionJan 12, 2026Obstruction of Flow

  (B)(6), AN RN IN THE CVICU, CALLED INTO EMERGENCY SUPPORT PROGRAM LINE TO REQUEST SUPPORT WITH A CLOTTED INNER LUMEN. ESP PERSONNEL REVIEWED A SCREENSHOT THAT SHOWED 244/243 AS THE ARTERIAL PRESSURE. ESP PERSONNEL EXPLAINED THAT SINCE THE INNER LUMEN WAS CLOTTED, IT NEEDED TO BE CAPPED, AND THE TRANSDUCER TUBING CONNECTED TO THE INNER LUMEN NEEDED TO BE DISCONNECTED AND DISCARDED. ESP PERSONNEL ALSO EXPLAINED THE INNER LUMEN NEEDED TO BE LABELED DO NOT USE DUE TO RISK FOR THROMBUS. ESP PERSONNEL EXPLAINED TO (B)(6) THAT THE RADIAL ARTERIAL LINE WOULD NEED TO BE TRANSDUCED TO THE PUMP AS THE ALTERNATE PRESSURE SOURCE TO SAFELY AND APPROPRIATELY TIME THE PUMP. (B)(6) STATED THAT HE WOULD CALL DIRECTLY IF HE WAS UNABLE TO TRANSDUCE THE RADIAL ARTERIAL LINE TO THE PUMP. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035040 ↗
• MalfunctionOct 21, 2025Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING USE INTRA-AORTIC BALLOON (IAB) CATHETER FAILED DURING THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23345206 ↗
• MalfunctionSep 11, 2025Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT DURING THE INTRA-AORTIC BALLOON THERAPY; BALLOON TIP LEAKAGE WAS DETECTED AT THE TIME OF INSERTION. NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23023642 ↗
• MalfunctionFeb 28, 2025Difficult to Insert; Difficult to Insert

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21490885 ↗
• MalfunctionNov 7, 2023Inability to Auto-Fill; Leak/Splash; Inability to Auto-Fill; Leak/Splash

  IT WAS REPORTED THAT AFTER APPROXIMATELY TWO HOURS OF INTRA-AORTIC BALLOON (IAB) THERAPY, BLOOD WAS SEEN IN THE HELIUM TUBING AND INTO THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP). PUMPING STOPPED SUDDENLY WITHOUT ANY AUDIBLE ALARMS. THE IAB WAS REMOVED. A REPLACEMENT IAB WAS NOT INSERTED BECAUSE THE PATIENT MAINTAINED A STABLE CONDITION AFTER REMOVAL. IT WAS NOTED THAT THE IABP ALARM LOG INDICATED CATHETER RESTRICTION AND AUTOFILL FAILURE ALARMS. 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 CARDIOSAVE IABP UNDER MFG REPORT NUMBER 2249723-2023-04675.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18086218 ↗
• MalfunctionJul 18, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT IMMEDIATELY AFTER INSERTING THE INTRA-AORTIC BALLOON (IAB), THE PUMP GENERATED A TWISTED CATHETER ALARM EVERY 20 MINUTES. IT WAS NOTED THAT ANOTHER MANUFACTURER'S PUMP WAS BEING USED. PUMPING WAS PAUSED, FORCING THE OPERATORS TO TURN OFF THE ALARM AND MANUALLY RESTART THE IAB. IT WAS NOTED THAT UNDER THE FLUOROSCOPIC CONTROL, NO IMAGE COMPATIBLE WITH KINKING OR TWISTING OF THE IAB WAS FOUND, WHICH IT WAS THEREFORE DECIDED TO LEAVE THE IAB IN PLACE. THE IAB WAS REMOVED AFTER TWO DAYS OF THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17342845 ↗
• MalfunctionMay 25, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED DURING INSERTION OF THE INTRA-AORTIC BALLOON (IAB), THE CUSTOMER HAD TECHNICAL DIFFICULTY INSERTING THE KIT'S DILATOR/INTRODUCER INTO THE SHEATH. A NEW IAB WAS OPENED TO USE THE NEW INTRODUCERS/DILATORS. AFTER THE EXCHANGE, THE PROCEDURE WAS CARRIED OUT SUCCESSFULLY AND WITHOUT DIFFICULTIES. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002339 ↗
• MalfunctionMar 6, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER ALMOST FIVE HOURS OF INTRA-AORTIC BALLOON (IAB) THERAPY, A LEAK OCCURRED AND BLOOD WAS BACKING UP TO THE CONSOLE. THE CONSOLE DID NOT STOP AND NO ALARMS WERE GENERATED. THE IAB WAS REMOVED AND A LEAK WAS FOUND IN THE DISTAL PART OF THE IAB. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16488160 ↗
• MalfunctionOct 25, 2022Deflation Problem; Difficult to Insert; Deflation Problem; Difficult to Insert

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666655 ↗
• MalfunctionOct 24, 2022Deflation Problem; Difficult to Insert; Deflation Problem; Difficult to Insert

  IT WAS REPORTED THAT PRIOR TO INSERTION, THE INTRA-AORTIC BALLOON (IAB) DID NOT DEFLATE PROPERLY AND COULD NOT BE INSERTED. A NEW IAB WAS USED, BUT THE SAME ISSUE OCCURRED. A THIRD IAB WAS SUCCESSFULLY INSERTED TO CONTINUE THERAPY. 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 2248146-2022-00838.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15663547 ↗
• MalfunctionFeb 28, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) LABEL STICKER HAD TWO DIFFERENT SIZES MENTIONED ON IT. THE CUSTOMER STATED THAT THERE WERE THREE IABS WITH THIS SAME ISSUE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED. THIS REPORT IS FOR ONE OF THE THREE IABS. TWO ADDITIONAL REPORTS WILL BE SUBMITTED FOR THE OTHER TWO IABS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13623817 ↗
• MalfunctionFeb 28, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) LABEL STICKER HAD TWO DIFFERENT SIZES MENTIONED ON IT. THE CUSTOMER STATED THAT THERE WERE THREE IABS WITH THIS SAME ISSUE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED. THIS REPORT IS FOR ONE OF THE THREE IABS. TWO ADDITIONAL REPORTS WILL BE SUBMITTED FOR THE OTHER TWO IABS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13623240 ↗
• MalfunctionFeb 28, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) LABEL STICKER HAD TWO DIFFERENT SIZES MENTIONED ON IT. THE CUSTOMER STATED THAT THERE WERE THREE IABS WITH THIS SAME ISSUE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED. THIS REPORT IS FOR ONE OF THE THREE IABS. TWO ADDITIONAL REPORTS WILL BE SUBMITTED FOR THE OTHER TWO IABS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13623130 ↗
• MalfunctionAug 25, 2021Difficult to Insert; Difficult to Insert

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365796 ↗
• MalfunctionAug 25, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) COULD NOT BE INSERTED THROUGH THE INTRODUCER SHEATH. THE CUSTOMER NOTED THAT THEY HAD USED THE SHEATH PROVIDED WITH THE IAB. A NEW IAB WAS INSERTED, BUT THE SAME ISSUE OCCURRED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT. THIS REPORT IS FOR THE SECOND IAB USED IN THIS EVENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE FIRST IAB USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365794 ↗
• MalfunctionApr 27, 2021Infusion or Flow Problem; Infusion or Flow Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11731383 ↗
• MalfunctionApr 27, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT ONCE THE INTRA-AORTIC BALLOON (IAB) WAS PLACED, IT WAS FLUSHED IMMEDIATELY. THE IAB WOULD NOT ASPIRATE. A SECOND IAB WAS PLACED AND FLUSHED, BUT THE SAME ISSUE OCCURRED AND THE IAB WOULD NOT ASPIRATE. A THIRD IAB WAS INSERTED WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED. THIS REPORT IS FOR THE FIRST IAB USED IN THIS EVENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE SECOND IAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11731284 ↗
• MalfunctionMar 26, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE IAB RUPTURED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11578473 ↗
• MalfunctionMar 26, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE IAB RUPTURED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11578466 ↗
• InjuryMar 26, 2021Leak/Splash; Pressure Problem; Leak/Splash; Pressure Problem

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON(IAB) THERAPY, THE CONSOLE ALARMED HIGH PRESSURE ALARM AND SHUT OFF. BLOOD QUICKLY FILLED HELIUM TUBING. PATIENTS PRESSURES DROPPED, BECAME SYMPTOMATIC, PALE, ANXIOUS, DIZZY. CV CODE CALLED. CV CODE TEAM THREADED NEW IABP INTO AXILLARY SITE, REMOVED OLD IABP. OLD IABP HAD BROKEN WIRE AND BLOOD IN HELIUM TUBING. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE.

  Patient problems: Emotional Changes; Low Blood Pressure/ Hypotension

  MAUDE report 11578219 ↗