Sensation Plus 7.5Fr. 40cc IAB with Accessories, US Only 0684-00-0568-01URecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10607567109565), received between Dec 17, 2018 and Sep 29, 2026 — classified as 3 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (9 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-2221-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930761 ↗
• MalfunctionSep 18, 2026Inappropriate Waveform; Device Sensing Problem; No Pressure

  It was reported by direct call from the customer to the Emergency Support Program, that during use of Sensation Plus 40cc balloon catheter a poor-quality arterial waveform on the IABP monitor while using the FiberOptix (FO) signal as the AP source. The FO arterial waveform displayed a whip-like artifact with pressure readings of 52/20 mmHg (MAP 44) and augmentation of 62. Comparison with the bedside monitor using the radial arterial line showed stable pressures of 104/61 mmHg (MAP 80). Troubleshooting, including multiple flushes of the inner lumen, did not resolve the waveform artifact. Review of a chest X-ray confirmed the distal radiopaque marker was positioned between the 2nd and 3rd intercostal spaces. Technical Support recommended switching the AP source from FO to the transducer and guided the clinician through the process. Following the change, appropriate arterial waveforms and pressure values were obtained. No patient harm or injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50816169 ↗
• MalfunctionSep 18, 2026Obstruction of Flow

  It was reported by direct call from the customer to the Emergency Support Program, that during use of Sensation Plus 40cc balloon catheter the inner lumen of the IAB catheter was clotted; customer was advised to remove the fluid-filled pressurized bag from the inner lumen and label it "Do Not Use" due to the risk of thrombus. The Fiber-Optic (FO) cable was being used as the arterial pressure source. The customer reported a Lead Fault on a CARDIOSAVE IABP in Auto Mode, intermittently switching to Pressure Trigger. The customer was advised to replace the ECG electrodes, apply Doppler gel, and reposition the electrodes closer to the heart to improve conduction. At the time of the call, the ECG waveform was clean, and the customer agreed to follow the recommendations if needed. No harm to the patient reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50814049 ↗
• MalfunctionSep 16, 2026Obstruction of Flow

  During an Emergency Support Program call, an ICU Registered Nurse (RN) with the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) in Standby, attempted to aspirate the Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon (IAB) inner lumen and obtained less than 1 one cubic centimeter of blood; the inner lumen was determined to be clotted. The inner lumen was advised to be capped and labeled "Do Not Use, Risk of Thrombus." The Fiber Optic pressure signal remained functional and provided the most reliable available arterial pressure waveform. Alternative arterial pressure source requirements were reviewed if the Fiber Optic signal became unavailable or inadequate. No harm or injury to the patient was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785808 ↗
• InjurySep 16, 2026Migration

  During an Emergency Support Program call, a CVICU RN requested assistance on behalf of a physician regarding repositioning of a Sensation Plus 7.5Fr. 40cc intra-aortic balloon (IAB) catheter. The physician reported that the chest X-ray showed the radiopaque distal marker approximately 6 cm below the carina. Further investigation determined that the patient had experienced a cardiac arrest, during which the IAB catheter migrated to approximately the 6th-7th intercostal spaces, followed by a decrease in arterial pressure readings.

  Patient problems: Insufficient Information

  MAUDE report 50784767 ↗
• MalfunctionSep 15, 2026Leak/Splash; Obstruction of Flow

  It was reported by a direct call from the customer to the Emergency Support Program, that during use of Sensation Plus 40cc balloon catheter a suspected perforation during Cardiosave therapy occurred, followed by multiple restriction alarms and blood observed in the catheter. The customer was advised to stop therapy, disconnect the device per protocol, and arrange prompt catheter removal. No blood was reported in the helium tubing beyond the connector or near the pump. No harm to the patient reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771779 ↗
• MalfunctionSep 14, 2026Obstruction of Flow; Device Sensing Problem; Infusion or Flow Problem

  During an Emergency Support Program call, the customer reported a Fiber-Optic Sensor Failure alarm following an attempt by a provider to reposition the Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon (IAB) catheter at the bedside. Augmentation was present; however, the arterial pressure displayed as 224/219 mmHg. The customer was unable to aspirate the inner lumen, and the lumen was considered clotted; guidance was provided to cap and label the inner lumen and discontinue its use. The customer was guided through connecting a radial arterial line to the pump, after which appropriate arterial pressure waveforms and values were obtained. The customer was instructed to retain the IAB catheter for evaluation and return it using a biohazard kit.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50751016 ↗
• MalfunctionSep 14, 2026Difficult to Flush; Obstruction of Flow

  During an Emergency Support Program call, the customer reported loss of the arterial pressure waveform after the patient had been ambulating and returned from the bathroom. Multiple attempts to flush the Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon (IAB) inner lumen were unsuccessful, and the inner lumen was considered clotted; guidance was provided to cap and label the inner lumen and discontinue use. The Fiber-Optic source was reportedly not being used due to a previously reported issue, although it had functioned as expected during a prior call on 17 August. The customer declined further Fiber-Optic troubleshooting and planned to obtain an alternate arterial pressure source via radial arterial line. The IAB was axillary placed, and the appropriate axillary placement considerations were reviewed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50750560 ↗
• MalfunctionSep 10, 2026Device Sensing Problem

  It was reported by the customer, through the Emergency Support Program call, a Fiber-Optic Sensor Failure during use with an axillary-placed Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon (IAB). The Fiber-Optic cable was not initially connected to the CARDIOSAVE, and the pump did not recognize the Fiber-Optic connection after reconnection; however, the same cable was recognized when connected to a second CARDIOSAVE. After the cable was reconnected to the original pump, a Fiber-Optic Sensor Failure alarm occurred, indicating an issue with the Fiber-Optic sensor associated with the IAB catheter. The Fiber-Optic sensor was labeled "Do Not Use - Fiber Optic Sensor Failure," arterial pressure monitoring was resumed through the transduced inner lumen with appropriate readings.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50711569 ↗
• MalfunctionSep 2, 2026Restricted Flow rate; Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50562812 ↗
• MalfunctionAug 31, 2026Obstruction of Flow; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50523120 ↗
• MalfunctionAug 27, 2026Migration

  During an Emergency Support Program call, assistance was requested with a Supraoptimal Augmentation on a CARDIOSAVE Intra-Aortic Balloon Pump (IABP) using a Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon (IAB) during support. The IAB tip was reported to be positioned between the 4th and 5th intercostal spaces. The recommendation for positioning between the 2nd and 3rd intercostal spaces was discussed; however, it was reported that the physician considered the placement appropriate based on the patient¿s anatomy. No harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50472304 ↗
• MalfunctionAug 26, 2026Inability to Auto-Fill; Restricted Flow rate; Gas/Air Leak

  During an Emergency Support Program call, an Autofill Failure alarm was reported on a CARDIOSAVE Intra-Aortic Balloon Pump (IABP) during patient support with a Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon (IAB) catheter. Prior to the call, the original pump had displayed Gas Loss, Gas Gain, and Autofill Failure alarms. In an attempt to resolve the issue, the clinical team exchanged the pump; however, the replacement pump also displayed an Autofill Failure alarm. Multiple attempts to resume therapy using the IAB Fill and Start keys on both pumps were unsuccessful, with the alarm recurring each time.The customer reported the IAB catheter had been inserted via the axillary approach, had been in place for five days, and the patient had been sitting upright. No blood or discoloration was observed in the helium tubing, all tubing connections were secure, and no external kinks were identified. A chest X-ray was pending at the time of troubleshooting. Multiple interventions to relieve a suspected catheter kink were unsuccessful. A Cardiac Physician Assistant attempted to remove sutures and relieve a suspected external kink without success. After the IAB had remained in Standby for appro

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50449721 ↗
• MalfunctionAug 7, 2026Obstruction of Flow

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50170639 ↗
• MalfunctionMay 29, 2026Break; Obstruction of Flow; Deformation Due to Compressive Stress; Device Sensing Problem

  IT WAS REPORTED THROUGH A DIRECT CALL FROM THE CUSTOMER TO THE EMERGENCY SUPPORT PROGRAM, THAT DURING USE OF SENSATION PLUS 40CC BALLOON CATHETER CUSTOMER REQUESTED ASSISTANCE WITH FIBER-OPTIC SENSOR FAILURE ALARM. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330170 ↗
• MalfunctionMay 26, 2025Device Sensing Problem; Appropriate Device Problem Term/Code Not Available; Device Sensing Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING INTRA AORTIC BALLOON THERAPY, FIBER OPTIC SENSOR FAILED. THERE WAS NO PATIENT INJURY OR HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084206 ↗
• MalfunctionApr 22, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED DURING USE THAT INTRA-AORTIC BALLOON(IAB) RN CALLS FROM THE CCL STATING THEY HAVE PLACED A SENSATION PLUS IAB AND HAVE RECEIVED A FO SENSOR FAILURE ALARM ON THE CARDIOSAVE CONSOLE. NO HARM OR INTERRUPTION OF THERAPY DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882482 ↗
• MalfunctionMar 18, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING INTAR AORTIC BALLOON(IAB) THERAPY A RESTRICTION ALARM WAS RECEIVED ON A CARDIOSAVE PRIOR SHIFT. THE PATIENT WAS TAKEN TO THE CARDIAC CATH LAB FOR IAB EXCHANGE WHERE UNDER IMAGING, THE RADIOPAQUE MARKERS APPEARED TO BE CLOSE TOGETHER, NEAR THE MIDDLE OF THE CATHETER. NO PATIENT INJURY OR HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21629954 ↗
• MalfunctionMar 18, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON THERAPY, THE PUMP SHOWED "SENSOR FAILURE" ERROR MESSAGE.

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

  MAUDE report 21628890 ↗
• InjuryMar 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  N/A.

  Patient problems: Implant Pain; Nausea

  MAUDE report 21501533 ↗
• MalfunctionFeb 19, 2025Device Sensing Problem; Device Sensing Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409426 ↗
• MalfunctionJan 23, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) HAD A CATHETER RESTRICTION ALARM ON INSERTION.

  Patient problems: Insufficient Information

  MAUDE report 21216705 ↗
• MalfunctionMay 11, 2022Inflation Problem

  PT REQUIRED BALLOON PUMP DURING CASE AND THE FIRST BALLOON PUMP KIT WE OPENED DID NOT INFLATE PROPERLY AFTER PLACING INTO THE PATIENT. THE CO2 TUBING WAS OBSTRUCTED AND NOT ALLOWING THE BALLOON TO INFLATE. THE BALLOON WAS REMOVED FROM THE PATIENT AND ENTIRE KIT WAS REMOVED FROM THE FIELD. A NEW BALLOON KIT WAS OPENED AND PLACED CORRECTLY INTO THE PATIENT. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 14375408 ↗
• InjuryDec 17, 2018Backflow; Fracture; Material Rupture; Noise, Audible

  PATIENT HAD AN IABP PLACED PRIOR TO A CABG SURGERY. FOLLOWING, THE IABP BECAME LOUD AND BLOOD WAS BAKING UP INTO THE TUBING. THE BALLOON HAD RUPTURED INSIDE OF PATIENT. SURGEON REMOVED CATHETER AND PLACED A NEW ONE. THE NEXT DAY, IABP BEGAN ALARMING TO "CHECK CATHETER" WHEN IN 1:1. IT RAN WITHOUT ISSUE ON 1:2. IABP HELIUM TUBING WAS NOTED TO HAVE BLOOD FLECKS IN IT. THE BALLOON HAD RUPTURED AGAIN INSIDE OF PATIENT. THE PROVIDER ATTEMPTED TO REMOVE THE IABP THROUGH THE SHEATH AND THE CATHETER FRACTURED. SHEATH AND REMAINING PORTION OF CATHETER WERE THEN REMOVED. PTS. BLOOD PRESSURE DECREASED DURING MANUAL COMPRESSION REQUIRING ALBUMIN, LEVOPHED AND DOBUTAMINE. HEMOGLOBIN DROPPED FROM 9.4 TO 7.1 BY THE FOLLOWING MORNING. PT. REQUIRED 1 UNIT OF PRBCS.

  Patient problems: Foreign Body In Patient; Low Blood Pressure/ Hypotension

  MAUDE report 8168740 ↗