Sensation 7Fr. 34cc IAB 0684-00-0469-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI 10607567106755), received between Sep 2, 2020 and Apr 16, 2026 — classified as 3 deaths, 2 injuries, 111 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (31 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-2217-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 116 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Device Sensing Problem

  IT WAS REPORTED BY THE CUSTOMER VIA EMERGENCY SUPPORT PROGRAM LINE, THAT THE INTRA AORTIC BALLOON (IAB) SENSATION 34CC HAD A FIBER OPTIC SENSOR FAILURE ALARM. THERE WERE NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24902169 ↗
• MalfunctionMar 14, 2026Pressure Problem

  DR (B)(6), A RESIDENT IN THE CICU, CALLED THE EMERGENCY SUPPORT PROGRAM LINE TO REQUEST SUPPORT REGARDING THE AUGMENTATION BEING LOWER THAN EXPECTED. HE EXPLAINED THAT THE PATIENT ORIGINALLY HAD A FEMORAL BALLOON, WHICH WAS LATER EXCHANGED FOR AN AXILLARY BALLOON. THE ESP TEAM PROVIDED HIM WITH THE AXILLARY DISCLAIMER AND REVIEWED SCREENSHOTS SHOWING APPROPRIATE WAVEFORMS AND NUMBERS, WITH THE AUGMENTATION BEING CLOSE TO THE SYSTOLIC PRESSURE. IT WAS EXPLAINED THAT THE CHANGE IN AUGMENTATION WAS DUE TO THE AXILLARY INSERTION WITH ITS UPSIDE-DOWN ORIENTATION AND THE SMALLER BALLOON SIZE COMPARED TO THE PREVIOUS 50 CC FEMORAL BALLOON, RATHER THAN ANY DEVICE MALFUNCTION. NO PATIENT HARM OR INJURY WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24599880 ↗
• MalfunctionMar 12, 2026Device Sensing Problem

  (B)(6) RN CCU CALLED INTO EMERGENCY SUPPORT PROGRAM LINE TO REQUEST SUPPORT WITH HER PATIENT HAD BEEN MOVING AROUND QUITE A BIT AND CAUSED A FO SENSOR FAILURE ALARM TO OCCUR. ALL ATTEMPTS AT TROUBLESHOOTING AND REGAINING THE FO AP WERE UNSUCCESSFUL. ESP TEAM REVIEWED THE MANY OPTIONS OF OBTAINING AN AP WAVEFORM ON THE CARDIOSAVE. (B)(6) DOES NOT HAVE THE CORRECT CABLES AT THIS TIME TO CONNECT AN ALTERNATE AP BUT STATES SHE WILL FIND THEM AND CALL BACK IF NECESSARY. SHE STATES THERE IS NO HARM TO THE PATIENT OR LAPSES IN THERAPY PROVIDED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579303 ↗
• MalfunctionFeb 3, 2026Restricted Flow rate; Leak/Splash; Device Contamination with Body Fluid

  (B)(6), AN RN IN THE ICU, CALLED INTO EMERGENCY SUPPORT PROGRAM LINE TO REQUEST SUPPORT WITH A CATHETER RESTRICTION ALARM. SHE STATED THE PUMP WAS NOT WORKING. WHEN ASKED, (B)(6) STATED THE PUMP HAD BEEN IN STANDBY FOR 15 MINUTES. ON PRESSING THE START KEY, THERE WAS A GAS LOSS ALARM THAT SOUNDED. ON ASKED IF THERE WAS IN BLOOD IN THE HELIUM TUBING, (B)(6) CONFIRMED YES. ON GUIDANCE, (B)(6) DISCONNECTED THE HELIUM TUBING, CLAMPED IT, AND CALLED THE PHYSICIAN FOR REMOVAL. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24243581 ↗
• MalfunctionNov 28, 2025Restricted Flow rate; Pacing Problem; Deformation Due to Compressive Stress; Restricted Flow rate; Pacing Problem; Deformation Due to Compressive Stress

  THE COMPLAINT WAS RECEIVED THROUGH A DIRECT CALL FROM THE CUSTOMER TO THE EMERGENCY SUPPORT PROGRAM. NO HARM OR INJURY TO THE PATIENT WAS REPORTED. IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE BLOOD PRESSURE NUMBERS FROM BALLOON PUMP AND BEDSIDE MONITOR WERE SO DIFFERENT. COMPLAINT INFORMATION OBTAINED. WE ALSO DISCUSSED THE QUALITY OF BALLOON WAVEFORM WHICH WAS INDICATIVE OF POSSIBLE KINK OR RESTRICTION SOMEWHERE IN THE HELIUM PATHWAY, BUT SHE DENIED ANY VISUALIZED RESTRICTION. (B)(6) TEXTED ME AT 4:47 PM EST INFORMING THE BEDSIDE PROVIDER WAS UNABLE TO ATTEMPT TO ASPIRATE DUE TO OTHER URGENT NEEDS IN THE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23672264 ↗
• MalfunctionNov 6, 2025Failure to Sense; Obstruction of Flow; Device Sensing Problem; Failure to Sense; Obstruction of Flow; Device Sensing Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486673 ↗
• DeathAug 6, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED DURING INTRA-AORTIC BALLOON THERAPY THAT THE PATIENT ON CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD PASSED AWAY. DURING USE, THE PUMP WENT INTO STANDBY MODE. THE ICU RN, INITIALLY COULD NOT IDENTIFY THE ALARM BUT LATER REPORTED A RECENT GAS LOSS ALARM. SHE PERFORMED TROUBLESHOOTING BY PRESSING THE START AND IAB FILL BUTTONS, AND THERAPY WAS RESTARTED. NO BLOOD, DISCOLORATION, OR PARTICLES WERE OBSERVED IN THE HELIUM TUBING, AND ALL CONNECTIONS WERE SECURE. A SCREENSHOT OF THE IABP MONITOR SHOWED APPROPRIATE WAVEFORMS AND BLOOD PRESSURE INDICES. THE PATIENT WAS REPORTEDLY ON A VENTILATOR, COUGHING DURING SUCTIONING, AND IN SINUS TACHYCARDIA, WHICH WERE CONSIDERED CONTRIBUTING CLINICAL FACTORS TO THE ALARM.

  Patient problems: Cough; Tachycardia

  MAUDE report 22724801 ↗
• MalfunctionJul 30, 2025Optical Problem; Optical Problem

  IT WAS REPORTED THAT AFTER INSERTING THE SENSATION 7 FR 34CC 35CC INTRA AORTIC BALLOON (IAB) CATHETER SHOWING UNUSUAL NUMBERS ON HER BALLOON PUMP. ARTERIAL PRESSURE WAS READING 44/0 ON THE PUMP. HOWEVER, THE BEDSIDE MONITOR BLOOD PRESSURE WAS 110S/50S. ALSO THE FIBER OPTIC WOULD NOT CALIBRATE WITH AN IAB OPTICAL SENSOR CALIBRATION EXPIRED MESSAGE. INNER LUMEN WERE FLUSHED EVERY 4 HOURS FOR A COUPLE OF SECONDS. THEY WERE ABLE TO ASPIRATE 3 CC OF BLOOD FROM THE INNER LUMEN. WHEN INNER LUMEN WERE FLUSH THE TRANSDUCER SET UP, THE BLOOD IN THE TRANSDUCER TUBING WOULD NOT FLUSH. THEN TO CHANGE A NEW TRANSDUCER SET UP. THE LINE WOULD STILL NOT FLUSH. GETINGE PERSON EXPLAINED IF THE INNER LUMEN WOULD NOT FLUSH AND THE FIBER NO SHOWING ACCURATE NUMBERS, THEY WOULD NEED TO USE AN ALTERNATE ARTERIAL SOURCE. CUSTOMER TRANSDUCED THE RADIAL ARTERIAL LINE. HAVING NUMBERS OF 139/131 AFTER BEING ZERO-ED. CUSTOMER CONFIRMED THE BALLOON PUMP HAD ¿NORMAL¿ NUMBERS. SHE STATED THE IABP WAS READING 113/58 WITH MAP OF 64 AND AUGMENTATION OF 95. AND ARTERIAL LINE ON THE MONITOR WAS NOW READING 113/52 WITH A MAP OF 67. THIS LED TO CONCLUSION THAT POSSIBLY THE IAB TIP MAY HAVE BEEN UP AGAINST THE AORTIC WALL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662904 ↗
• MalfunctionJul 20, 2025Difficult to Flush; Difficult to Flush

  CUSTOMER CALLED STATING HE IS NEW TO IABP THERAPY AND CARING FOR ITS PATIENTS. HE STATES HE CANNOT FLUSH THE INNER LUMEN OF A FO IAB. HE STATES HE HAS TALKED TO THE PHYSICIAN, AND THEY ARE UNSURE ON HOW TO PROCEED. THE THERAPY IS RUNNING AS EXPECTED ON A CS300 PUMP. PATIENT WAS INVOLVED. NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552220 ↗
• MalfunctionJul 18, 2025Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22539675 ↗
• MalfunctionJun 30, 2025No Device Output; Failure to Sense; No Device Output; Failure to Sense

  IT WAS REPORTED BY NURSE THAT DURING IAB (INTRA AORTIC BALLOON) THERAPY, THE FIBER OPTIC SENSOR FAILURE OCCURED IN A SENSATION 34CC BALLOON. THERE WAS NO HARM OR INJURY NOTED TO PATIENT. NURSE REPORTED SWITCHING TO THE INNER LUMEN. CUSTOMER STATED THAT THEY DO NOT FLUSH THE INNER LUMEN FREQUENTLY. NURSE COULD NOT ASPIRATE ANY BLOOD. DUE TO RISK OF THROMBUS, AN ALTERNATE ARTERIAL SOURCE WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22356027 ↗
• MalfunctionJun 12, 2025Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  N/A

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

  MAUDE report 22193337 ↗
• MalfunctionJun 4, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT DURING INTAR AORTIC BALLOON (IAB) THERAPY, THERE WAS A FIBER OPTIC SENSOR FAILURE. NO PATIENT HARM OR INJURY WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22138625 ↗
• MalfunctionMay 14, 2025Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT DURING INTAR AORTIC BALLOON (IAB) THERAPY, THE INTRA AORTIC BALLOON (IAB) WAS RUPTURED JUST AFTER INSERTION, WHEN IT WAS INSERTED CUSTOMER OBSERVED BLOOD INSIDE THE GAS LINE SO HE REMOVED THE BALLOON. THERE WAS NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22016937 ↗
• MalfunctionApr 17, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT DURING USE THE SENSATION 34CC, IAB (INTRA-AORTIC BALLOON PUMP) HAD FIBER OPTIC SENSOR FAILURE ON A CARDIOSAVE.

  Patient problems: Insufficient Information

  MAUDE report 21857004 ↗
• MalfunctionMar 31, 2025Backflow; Infusion or Flow Problem; Backflow; Infusion or Flow Problem

  IT WAS REPORTED THAT THE WHILE INSERTING INTRA-AORTIC BALLOON TR3455 USING THE CSAVE IN THE USUAL WAY, BACKFLOW WAS FOUND IN THE CATHETER, SO IT WAS IMMEDIATELY REMOVED. AFTER CONFIRMING THAT IT WAS NOT CONNECTED TO THE CSAVE, A NEW IAB CATHETER WAS REINSERTED AND THE PROCEDURE CONTINUED. NO HEALTH HAZARDS TO THE PATIENT WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21735896 ↗
• MalfunctionMar 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE I WHEN THE DOCTOR REMOVED THE INTRA-AORTIC BALLOON AND FOUND THAT THERE WAS SOME BLOOD AND "PLAQUES" APPEARED INSIDE THE BALLOON PART. PATIENT WAS INVOLVED.

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

  MAUDE report 21641887 ↗
• MalfunctionMar 12, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21581545 ↗
• MalfunctionMar 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED DURING USE THAT INTRA-AORTIC BALLOON(IAB) TR3455 WAS INSERTED AND OPERATED AT AROUND 12:00 ON (B)(6) 2025, BUT A GAS LOSS ALARM SOUNDED AT AROUND 16:00 ON THE SAME DAY. WHEN THE CATHETER EXTENSION TUBE WAS CHECKED, BLOOD WAS FOUND, AND BALLOON RUPTURE WAS SUSPECTED, SO OPERATION WAS STOPPED. THERE WAS NO INJURY OR HARM REPORTED TO THE PATIENT.

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

  MAUDE report 21546206 ↗
• MalfunctionMar 6, 2025Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT DURING IAB THERAPY, THE INTRA-AORTIC BALLOON PUMP (IABP) HAD A BALLOON RUPTURE RESULTING THE BLOOD ENTERING THROUGH THE BALLOON TO THE TUBING. NO PATIENT HARM OR INJURY WAS REPORTED.

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

  MAUDE report 21534354 ↗
• MalfunctionJan 17, 2025Leak/Splash; Leak/Splash

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

  Patient problems: Insufficient Information

  MAUDE report 21177212 ↗
• MalfunctionJan 15, 2025Difficult to Insert; Mechanical Problem; Difficult to Insert; Mechanical Problem

  IT WAS REPORTED THAT INTRA AORTIC BALLOON HAD AN ISSUE, UNABLE TO PASS THE GUIDEWIRE THROUGH BALLOON. THE HOSPITAL STAFF UTILIZED ANOTHER BALLOON AND THE SAME GUIDEWIRE PASSED THROUGH IT. THERE WAS NO PATIENT DEATH OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21156132 ↗
• MalfunctionDec 5, 2024Difficult to Insert; Difficult to Insert

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854796 ↗
• MalfunctionDec 5, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THERAPY, AN INTRA-AORTIC BALLOON (IAB) RUPTURE OCCURRED WHILE THE PATIENT UNDERWENT AN OPERATION. THE IAB WAS REMOVED AFTER APPROXIMATELY ONE DAY OF USE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854197 ↗
• MalfunctionDec 5, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT PRIOR TO INSERTING THE INTRA-AORTIC BALLOON (IAB), THE CUSTOMER APPLIED NEGATIVE PRESSURE TO THE IAB AND ATTEMPTED TO INSERT IT INTO THE SHEATH WHILE MAINTAINING THE NEGATIVE PRESSURE. HOWEVER, THE IAB BECAME STUCK INSIDE THE SHEATH. A NEW IAB WAS THEN SUCCESSFULLY INSERTED USING THE SAME PROCEDURE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854137 ↗