Sensation Plus 8Fr. 50cc IAB with Accessories, US Only 0684-00-0576-01URecalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10607567109633), received between Aug 26, 2020 and Sep 30, 2026 — classified as 56 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (14 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-2222-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Aug 5, 2022Class IIOpen, Classified

   Certain lots containing undersized dilator.

   Z-1686-2022 · Root cause: Vendor change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Device Sensing Problem

  During an Emergency Support Program call, a CCU RN reported a Fiber-Optic Sensor Failure on a CARDIOSAVE Intra-Aortic Balloon Pump (IABP) during support with a Sensation Plus 8Fr. 50cc Intra-Aortic Balloon (IAB). No harm was reported. The customer attempted to disconnect and reconnect the Fiber-Optic (FO) cable and perform a flush without resolution, and subsequently transitioned to the transduced inner lumen as the arterial pressure source. An appropriate arterial pressure waveform and pressure indices were reported after transition to the transducer. Additional troubleshooting of the FO system was offered but declined. The customer was advised to coil the FO cable and label it "Do Not Use." The customer confirmed that the pressure bag was maintained approximately three feet above the transducer on a standard IV pole. Information required for shipment of a biohazard return kit was obtained, and instructions for catheter return were provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943368 ↗
• MalfunctionSep 30, 2026Failure to Calibrate; Device Sensing Problem; Migration

  During an Emergency Support Program call, a CICU RN reported concerns regarding the Fiber-Optic arterial pressure waveform on a CARDIOSAVE Intra-Aortic Balloon Pump (IABP) during support with a Sensation Plus 8Fr. 50cc Intra-Aortic Balloon (IAB). The customer reported that the Fiber-Optic waveform appeared to contain artifact, with diastolic pressure intermittently decreasing to 0 or the teens and augmentation decreasing; the patient was reported to be in normal sinus rhythm without ectopy. A chest X-ray had been obtained, and the provider reported that there appeared to be no change in IAB position. Review of the available waveform showed no evidence of damping, and the radiopaque distal marker was positioned between the 4th and 5th intercostal spaces. Recommended IAB positioning was reviewed, and the customer was advised to notify the provider. The inner lumen was flushed through the transducer with the pump in Standby for approximately 20 seconds, but the waveform remained unchanged after therapy was resumed. An attempt was made to transition to the Transducer pressure source for comparison; however, the appropriate Interfacing Transducer Cable was not available. Potential cause

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943271 ↗
• MalfunctionSep 29, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930589 ↗
• MalfunctionSep 28, 2026Difficult to Insert

  It was reported that the customer experienced difficulty inserting a Sensation Plus 8Fr 50cc Intra-Aortic Balloon (IAB) catheter through the provided 8 French (Fr) sheath. It was reported that the cardiovascular surgeon was unable to advance the IAB catheter through the sheath and the catheter was subsequently discarded. A second Sensation Plus 8Fr 50cc IAB catheter was then used and was successfully inserted. No patient harm was reported.It was reported that on (b)(6) 2026, during an on-site discussion at (b)(6), the specifications of the Sensation 50cc IAB catheter were reviewed, including the importance of properly preparing the IAB catheter prior to insertion and ensuring that the one-way valve remained on throughout the insertion process. The cardiovascular surgeon reported that the balloon had been prepared with the one-way valve on the device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912573 ↗
• MalfunctionSep 28, 2026Restricted Flow rate

  During an Emergency Support Program call, a CVICU fellow reported a Catheter Restriction alarm during support with a Sensation Plus 8Fr. 50cc Intra-Aortic Balloon (IAB). The customer had turned the pump off, and therapy had been discontinued for approximately 30 minutes at the time of the call. Due to the duration of the pump being off and the associated risk of thrombus formation, the customer was advised to remove the IAB catheter. The nature of the Catheter Restriction alarm was reviewed, and the customer confirmed that the plan was to remove the IAB catheter. No patient harm or injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911911 ↗
• MalfunctionSep 25, 2026Inappropriate Waveform; Device Sensing Problem

  It was reported by direct call from the customer to the Emergency Support Program, that during use of Sensation Plus 50cc balloon catheter a Fiber Optic Sensor Failure alarm occurred on Cardiosave display with loss of the fiber optic signal and no A/P waveform displayed. The clinician confirmed there were no visible kinks in the FO cable and reinserted the cable correctly (red arrow to red arrow), but the alarm recurred. The patient had recently arrived from the OR following IABP placement. The user was instructed to transition from FO monitoring to a transduced pressure source and to coil, label, and remove the FO cable from use. IFU recommendations regarding pressure bag positioning and maintenance of inner lumen patency were also reviewed. No harm to the patient reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894947 ↗
• MalfunctionSep 25, 2026Inappropriate Waveform; Device Sensing Problem

  It was reported by direct call from the customer to the Emergency Support Program, that during use of Sensation Plus 50cc Intra-Aortic Balloon (IAB) catheter an intermittent Fiber-Optic Sensor Failure was reported. The user observed periodic loss of fiber-optic pressure monitoring, with decreased arterial pressure values and waveform distortion, followed by an automatic switch from Fiber-Optic (FO) to Transducer source. Troubleshooting, including reconnecting the FO sensor cable and re-zeroing the transducer, did not resolve the issue. A video confirmed the event, showing alteration of the arterial waveform and pressures, transition to the transducer source, and the appearance of an ¿FO Sensor Failure¿ message. The user reported no visible cable kinks, restrictions, or adapter damage.The FO sensor cable was disconnected, labeled, and removed from service. The transducer remained in use. No harm to the patient was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893831 ↗
• MalfunctionSep 22, 2026Leak/Splash; Increase in Pressure; Difficult to Remove

  It was reported that during therapy with Sensation Plus 50cc balloon catheter a repeated Gas Gain/Gas Loss alarms occurred. The pump had been replaced prior to thecall; however, the alarms continued despite the exchange. No blood was observed in the IAB catheter, all connections were verified as secure, and standard troubleshooting could not resolve the issue. The alarms reportedly began after the patient was transferred from the catheterization laboratory table to a bed. The balloon waveform was described as normal, with no apparent restrictions or kinking noted. According to physician, significant resistance was encountered while removing the initial balloon catheter through the sheath, suggesting a potential sheath-related issue. The original balloon was exchanged using an Avanti 8 Fr femoral sheath, after which no further issues were reported with the replacement balloon. No harm to the patient reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850710 ↗
• MalfunctionSep 17, 2026Failure to Calibrate

  It was reported that a Sensation Plus 40cc balloon catheter was inserted, but could not be calibrated. A second balloon catheter was subsequently used and calibrated successfully without issues. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801850 ↗
• MalfunctionSep 17, 2026Leak/Splash; Device Sensing Problem

  It was reported by direct call from the customer to the Emergency Support Program, that during use of Sensation Plus 50cc physician requested assistance with waveform interpretation issues and multiple Gas Loss alarms during Cardiosave therapy following coronary artery bypass grafting. Troubleshooting included ECG electrode replacement, FO cable recalibration, and lumen patency verification, resulting in improved signal quality and stable pressure monitoring. No blood was observed in the helium tubing, the alarms were considered likely related to the patient's postoperative condition. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797917 ↗
• MalfunctionSep 2, 2026Inappropriate Waveform; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50561490 ↗
• MalfunctionSep 2, 2026Restricted Flow rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50558250 ↗
• MalfunctionSep 1, 2026Failure to Calibrate; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50542038 ↗
• MalfunctionSep 1, 2026Obstruction of Flow; Device Sensing Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50538545 ↗
• MalfunctionAug 31, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50519995 ↗
• MalfunctionAug 31, 2026Signal Artifact/Noise; Improper Flow or Infusion; Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50515564 ↗
• MalfunctionAug 28, 2026Device Sensing Problem; Material Deformation; Material Split, Cut or Torn

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50493646 ↗
• MalfunctionAug 22, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50388610 ↗
• MalfunctionAug 22, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50387097 ↗
• MalfunctionAug 20, 2026Signal Artifact/Noise; Break; Obstruction of Flow; Material Deformation

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50346981 ↗
• MalfunctionAug 17, 2026Restricted Flow rate; Inflation Problem; Obstruction of Flow; Device Sensing Problem; Migration

  An RN in the Cath lab, called with abnormal arterial waveform. ESP personnel reviewed a screenshot that showed abnormal arterial waveform, suboptimal augmentation, and catheter restriction in the balloon waveform. ESP personnel asked if the radiopaque tip was between the 2nd and 3rd intercostal space. ESP personnel was sent a video of the balloon under fluro. It did not show where the radiopaque tip was in relation to the intercostal spaces, but the balloon did not appear to be fully inflating. Nurse stated he was going to take another picture, call the physician, and then call me back. A few minutes later, ESP personnel received another fluro picture that was still unclear in positioning. ESP personnel spoke with Jason again. ESP personnel suggested we try a manual inflation to confirm the balloon was fully unfurled and to get a more accurate picture to determine the placement of the balloon. Jason placed me on speaker phone. There were multiple people in the room. As ESP personnel was explaining how to perform the manual inflation, Nurse stated the waveform looked better. ESP personnel reviewed a picture with less restriction and slightly improved numbers. As ESP personnel asked

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50272940 ↗
• MalfunctionAug 14, 2026Leak/Splash; Gas/Air Leak; Material Deformation; Moisture or Humidity Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252037 ↗
• MalfunctionAug 10, 2026Fluid/Blood Leak; Difficult to Remove

  N/A

  Patient problems: Hematoma; Insufficient Information; No Clinical Signs, Symptoms or Conditions; Unspecified Vascular Problem

  MAUDE report 50194648 ↗
• MalfunctionJul 30, 2026Deflation Problem; Difficult to Insert; Suction Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50079529 ↗
• MalfunctionJul 30, 2026Device Sensing Problem

  During an Emergency Support Program call, the customer reported a Fiber-Optic Sensor Failure alarm on a CARDIOSAVE Intra-Aortic Balloon Pump (IABP) supporting a patient with a Sensation Plus 50cc Intra-Aortic Balloon catheter. Troubleshooting, including disconnecting and reconnecting the fiber-optic cable, was unsuccessful; the customer was instructed to disconnect the fiber-optic cable and continue therapy using the transduced inner lumen arterial pressure source, which was already connected and zeroed. No harm was reported. No further assistance was required. The customer requested an IAB catheter return kit. A return kit was sent, but it later returned to the manufacturer without the catheter.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50079244 ↗