Sensation 7Fr. 40cc IAB 0684-00-0470-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 247 adverse event reports that list this exact device (DI 10607567106779), received between Sep 16, 2020 and Aug 23, 2026 — classified as 14 deaths, 5 injuries, 228 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (84 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 247 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50396957 ↗
• MalfunctionMay 18, 2026Obstruction of Flow

  IT WAS REPORTED BY THE CUSTOMER VIA EMERGENCY SUPPORT PROGRAM LINE, THAT THE INTRA AORTIC BALLOON (IAB) SENSATION PLUS 40CC HAD A CLOTTED INNER LUMEN. THERE WERE NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25197882 ↗
• MalfunctionMar 30, 2026Obstruction of Flow; Device Sensing Problem

  A COMPLAINT WAS RECEIVED VIA A DIRECT CALL TO THE EMERGENCY SUPPORT PROGRAM REGARDING SENSATION 7FR. 40CC INTRA AORTIC BALLOON (IAB) THAT FIBER OPTIC SENSOR FAILURE ALARM ON A CARDIOSAVE DEVICE DURING USE. NO PATIENT HARM OR INJURY WAS REPORTED. TROUBLESHOOTING WAS PERFORMED WITH THE NURSE INCLUDING VERIFICATION OF PROPER FO CABLE CONNECTION. THE FSE WAS GUIDED TO TRANSITION FROM THE FIBER OPTIC SENSOR TO A TRANSDUCER PRESSURE SOURCE AND TO LABEL THE FO CABLE AS NOT FOR USE. FOLLOWING TRANSITION, THE INNER LUMEN WAS IDENTIFIED AS CLOTTED, AND THE FSE CAPPED AND LABELED THE LUMEN AND TRANSITIONED TO AN ALTERNATE ARTERIAL ACCESS (RADIAL ARTERIAL LINE). THE ISSUE WAS DETERMINED NOT TO BE A DEVICE MALFUNCTION. THE CALLER REPORTED NO ADDITIONAL NEEDS AFTER SUPPORT WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24725286 ↗
• MalfunctionFeb 27, 2026Device Sensing Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471969 ↗
• MalfunctionFeb 18, 2026Fluid/Blood Leak; Material Rupture

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24375670 ↗
• MalfunctionJan 7, 2026Pacing Problem; Device Sensing Problem; Appropriate Device Problem Term/Code Not Available

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23992958 ↗
• MalfunctionDec 5, 2025Device Sensing Problem; Device Sensing Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729648 ↗
• MalfunctionDec 4, 2025Difficult to Flush; Obstruction of Flow; Difficult to Flush; Obstruction of Flow

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717382 ↗
• MalfunctionNov 28, 2025Difficult to Flush; Difficult to Insert; Obstruction of Flow; Infusion or Flow Problem; Difficult to Flush; Difficult to Insert; Obstruction of Flow; Infusion or Flow Problem

  IT WAS REPORTED THAT BALLOON IS INSERTED UNDER ANGIOGRAPHIC GUIDANCE, ALREADY DURING INSERTION OF THE 0.018 GUIDE INSIDE THE BALOON THE CUSTOMER FEELS MORE DIFFICULTY THAN USUAL, ONCE THE GUIDE HAS BEEN REMOVED THE CUSTOMER IS PREPARING TO ASPIRATE AND WASH THE BALLOON, BUT NOTHING CAME FROM THE WASHING LINE, ASPIRATION WITH A 50CC SYRINGE IS DIFFICULT AND INFUSION PRACTICALLY IMPOSSIBLE. IN AGREEMENT WITH THE DOCTOR, IT IS DECIDED TO GO BACK UP WITH THE GUIDE, WITH DIFFICULTY THEY MANAGE TO GO UP AGAIN, BUT IN ANY CASE NO PATENCY IN ASPIRATION AFTER THE GUIDE HAS BEEN REMOVED. SO IT IS DECIDED TO CHANGE THE BALLOON, WHERE THE GUIDE CLIMBS WELL, THE INSERTION AND POSITIONING ALWAYS UNDER THE GUIDE OCCURS WITHOUT PROBLEMS, BUT A BIT OF DIFFICULTY IN ASPIRATING AND INFUSING IS STILL RECORDED, BUT IT IS DECIDED TO CONTINUE THE THERAPY. NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669465 ↗
• MalfunctionNov 25, 2025Difficult to Flush; Difficult to Insert; Infusion or Flow Problem; Difficult to Flush; Difficult to Insert; Infusion or Flow Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644219 ↗
• MalfunctionNov 3, 2025Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23445346 ↗
• MalfunctionOct 16, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH A DIRECT CALL FROM THE CUSTOMER, STATING THAT THE PATIENT WAS STABLE BUT AUGMENTATION WAS LOWER THAN THE SYSTOLIC. IT WAS ALSO MENTIONED THAT THE INNER LUMEN OF INTRA-AORTIC BALLOON (IAB) WAS CLOTTED. IT WAS DETERMINED THAT THE ALLEGED ISSUE WAS NOT RELATED TO A DEVICE MALFUNCTION, RATHER USER ERROR THAT ALLOWED THE INNER LUMEN TO CLOT. NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23307075 ↗
• MalfunctionOct 15, 2025Restricted Flow rate; Activation Failure; Restricted Flow rate; Activation Failure

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23287481 ↗
• MalfunctionSep 9, 2025Failure to Recalibrate; Failure to Sense; Failure to Recalibrate; Failure to Sense

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001572 ↗
• MalfunctionSep 2, 2025Device Sensing Problem; Optical Problem; Device Sensing Problem; Optical Problem

  IT WAS REPORTED THAT THE AFTER INSERTING THE SENSATION PLUS INTRA AORTIC BALLOON(IAB) CATHETER HAVE A BALLOON PUMP IN AND THE FIBER-OPTIC TIP FOR THE SENSATION IS NOT WORKING, THE PRESSURE IS NOT SHOWING UP ON THE BALLOON PUMP CONSOLE. SO, AN EXTERNAL OLD STYLE PRESSURE CABLE WAS ATTACHED AND IT IS ALSO NOT SHOWING UP UNLESS THE FO CABLE FROM THE BALLOON WAS UNPLUG AND IT USED TO SHOW BOTH LIKE BEFORE. TROUBLESHOOTING DETERMINED CUSTOMER WAS NOT ABLE TO GET TO THE BALLOON SITE OR CLEARLY VISUALIZE THE FIBER-OPTIC CABLE. SHE REPORTED RECEIVING A FIBER-OPTIC SENSOR FAILURE ALARM, BUT SHE WAS UNABLE TO CHANGE THE INTERFACING SETUP FOR EASY-TO-FOLLOW INTERVENTION TO RESOLVE THE ALARM. THERE WAS NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931858 ↗
• MalfunctionAug 3, 2025Infusion or Flow Problem; Positioning Problem; Misassembly by Users; Infusion or Flow Problem; Positioning Problem; Misassembly by Users

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22696338 ↗
• MalfunctionJul 28, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED BY NURSE THAT DURING IAB (INTRA AORTIC BALLOON) THERAPY, CONCERNS REGARDING POOR ARTERIAL WAVEFORM QUALITY. SHE DESCRIBED THE WAVEFORM AS ABNORMAL AND INCONSISTENT, EVEN WHEN THE PATIENT WAS NOT EXPERIENCING ECTOPY. THE CONSOLE SCREEN IMAGE SHOWED LOW PRESSURES (62/50), A POOR ARTERIAL WAVEFORM WITH WHIP, AND AN AUGMENTATION OF 75 MMHG. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22638453 ↗
• MalfunctionJul 21, 2025Restricted Flow rate; Material Deformation; Restricted Flow rate; Material Deformation

  IT WAS REPORTED DURING AN INTRA-AORTIC BALLOON THERAPY A CATHETER RESTRICTION ALARM WAS REPORTED DURING USE OF THE IAB CATHETER. UPON ASSESSMENT, A NOTICEABLE KINK WAS OBSERVED AT THE INSERTION SITE, LIKELY DUE TO A HIGH SHEATH PLACEMENT AND TIGHT DRESSING. THE CATHETER WAS REPOSITIONED BY THE PHYSICIAN; HOWEVER, THE RESTRICTION ALARM CONTINUED TO OCCUR APPROXIMATELY EVERY 10 MINUTES. NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553014 ↗
• MalfunctionJul 15, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY TRANS-RAY 40CC TRIGGERED AN "OPTICAL SENSOR FAILURE" ALARM. A NEW PRODUCT WAS ISSUED AND USED WITHOUT ISSUE. THERE WAS NO DAMAGE TO THE PATIENT'S HEALTH, NO DELAY IN THE PROCEDURE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22504718 ↗
• MalfunctionJul 14, 2025Gas/Air Leak; Gas/Air Leak

  N.A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22492072 ↗
• MalfunctionJul 14, 2025Moisture or Humidity Problem; Moisture or Humidity Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22491718 ↗
• MalfunctionJul 7, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING INTRA AORTIC BALLOON (IAB) THERAPY THEY WERE UNABLE TO INSERT THE BALLOON AFTER 4 ATTEMPTS. PROPER NEGATIVE PRESSURE WAS APPLIED AND A NEW CATHETER WAS INSERTED. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412673 ↗
• MalfunctionJun 23, 2025Break; Pacing Problem; Failure to Sense; Obstruction of Flow; Break; Pacing Problem; Failure to Sense; Obstruction of Flow

  IT WAS REPORTED THAT DURING INTRA AORTIC BALLOON (IAB) THERAPY, THE BALLOON DEVICE COULD NOT BE OPERATED VIA THE ARTERY SINCE THE PRESSURE SENSOR WAS NOT DETECTED. IT WAS REPORTED THAT THEY DID NOT SEE ANY HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22305668 ↗
• MalfunctionJun 10, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A LINEAR 34 CC INTAR-AORTIC BALLOON DID NOT OPEN. PRESSED IAB FILL BUTTON AND BALLOON STILL DID NOT INFLATE. PATIENT WAS INVOLVED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174976 ↗
• MalfunctionMay 21, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE ON PATIENT, TRANSRAY 40CC INTRA-AORTIC BALLOON (IAB) WAS INSERTED IN PATIENT AND AN ALARM OF "IAB CIRCUIT LEAK (GAS LOSS)" OCCURRED ON CS300 IABP. SIMILAR ALARMS OCCURRED FREQUENTLY HENCE THE CATHETER WAS REPLACED WITH ANOTHER TR4055. NO BLOOD WAS FOUND IN THE EXTENSION TUBE. THERE WAS NO HARM REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062134 ↗