SENSATION PLUS 7.5Fr. 40cc IAB & Accessories 0684-00-0568-01Recalls & reported problems
Datascope Corp. · SENSATION PLUS 7.5Fr. 40cc IAB & Accessories · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Datascope Sensation Plus is an intra-aortic balloon system with a control unit. Its 407 adverse event reports often describe sensor problems, leaks, and pressure readings, and some describe the balloon not inflating. The reports include 10 deaths and 8 injuries. One of the 2 recalls is open, over a part that can break during insertion; the other is closed.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 407
- Deaths reported
- 10
- Injuries reported
- 7
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 407 adverse event reports that list this exact device (DI 10607567108063), received between Aug 26, 2020 and Sep 28, 2026 — classified as 10 deaths, 7 injuries, 390 malfunctions.
The most frequently reported specific device problem is “Optical Problem” (160 reports).
2 FDA recall records 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.
Reports received per month
Recalls naming this device
- 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 ↗
- May 28, 2019Class IITerminated
The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured.
Z-1966-2019 · Root cause: Employee error · Recall details · FDA record ↗
Most reported problems
Device problems
- Optical Problem160
- Leak/Splash62
- Inappropriate Waveform30
- Pressure Problem29
- Material Deformation22
- Inability to Auto-Fill19
- Gas/Air Leak17
- Restricted Flow rate17
Patient problems
- No Clinical Signs, Symptoms or Conditions363
- No Consequences Or Impact To Patient19
- No Patient Involvement11
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- Insufficient Information7
- Cardiac Arrest3
- Cardiogenic Shock2
- Death2
Recent adverse event reports
The 25 most recent of 407 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912419 ↗MalfunctionAug 28, 2026Inflation Problem; Failure to Calibrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50494938 ↗MalfunctionMay 7, 2026Pacing Problem; Device Sensing Problem
IT WAS REPORTED BY THE CUSTOMER VIA EMERGENCY SUPPORT PROGRAM LINE, THAT THE INTRA AORTIC BALLOON (IAB) SENSATION PLUS 40CC HAD FIBER OPTIC SENSOR FAILURE AND DIFFICULT OR UNABLE TO MONITOR ARTERIAL PRESSURE WAVEFORM. THERE WERE NO PATIENT HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25110516 ↗MalfunctionApr 21, 2026Pacing Problem; Pressure Problem; Migration
(B)(6) A CCU RN CALLED INTO THE EMERGENCY SUPPORT PROGRAM LINE FOR ASSISTANCE WITH AUGMENTATION ON A CARDIOSAVE DURING USE. (B)(6) STATED THAT THE AUGMENTATION WAS LOWER THAN THE UNASSISTED SYSTOLIC PRESSURES. ESP PERSONNEL EXPLAINED THAT RECOMMENDATIONS FOR AUGMENTATION ARE GREATER THAN ASSISTED SYSTOLIC PRESSURES. AT THAT TIME MATTHEW THE CARDIAC EDUCATOR FOR THE FACILITY ALSO JOINED THE CALL AND HAD QUESTIONS ABOUT POSSIBLE TIMING ERRORS. ESP PERSONNEL REVIEWED ALL THE SETTINGS THE PUMP WAS CURRENTLY IN AS WELL AS THE MOST RECENT CHEST X RAY FOR PLACEMENT VERIFICATION. THE ECG HAD ARTIFACT AND A HEART RATE OF 62. IN ONE TO TWO THE ARTERIAL WAVEFORM WAS VIA FIBER OPTIC AND SHOWED SOME WHIP PRESENT WITH ASSISTED PRESSURES OF 119 OVER 48 MEAN 89 UNASSISTED PRESSURES OF 140 OVER 56 MEAN 89 AND AN AUGMENTATION OF 129. INFLATION APPEARED TO BE EARLY. IN ONE TO ONE THE PRESSURES WERE 106 OVER 43 MEAN 82 AND THE AUGMENTATION WAS 111. THE CHEST X RAY IMPRESSION STATED THAT THE IABP APPEARED WELL POSITIONED. THE CHEST X RAY IMAGE SHOWED THE DISTAL RADIOPAQUE MARKER TO BE IN THE FOURTH INTERCOSTAL SPACE. TROUBLESHOOTING INCLUDED REPLACING THE ELECTRODES FOR OPTIMAL PLACEMENT FLUSHING THE I
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939352 ↗MalfunctionMar 30, 2026Difficult to Flush; Obstruction of Flow
MalfunctionMar 25, 2026Restricted Flow rate
MalfunctionMar 19, 2026Obstruction of Flow
THE COMPLAINT WAS RECEIVED THROUGH A DIRECT CALL FROM THE CUSTOMER (REGISTERED NURSE) TO THE EMERGENCY SUPPORT PROGRAM. IT WAS REPORTED THAT WHILE USING SENSATION PLUS 7.5FR 40CC INTRA-AORTIC BALLOON (IAB), THE PATIENT WITH AN AXILLARY BALLOON. THEY¿VE BEEN FOLLOWING THEIR FORWARD FLOW POLICY AND FLUSHING EVERY 4 HOURS, BUT THEY¿RE LOSING THE INNER LUMEN AGAIN ON A LINE ON THE BLOOD PRESSURE. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24637678 ↗MalfunctionFeb 27, 2026Inflation Problem
(B)(6), A CATH LAB RN, CALLED INTO EMERGENCY SUPPORT PROGRAM LINE TO REQUESTING ASSISTANCE FOR A RECENTLY INSERTED FO BALLOON CATHETER BY DR. (B)(6). HE PLACED ESP TEAM ON SPEAKERPHONE, AND ESP TEAM WAS ABLE TO SPEAK WITH DR. (B)(6) WHO WAS STILL SCRUBBED IN AT THE CATH LAB TABLE. DR. (B)(6) STATED THE RADIOPAQUE MARKERS WERE IN THE CORRECT LOCATION UNDER FLUORO. HE REPORTED THE DISTAL PORTION OF THE BALLOON CATHETER WAS NOT INFLATING. ESP TEAM VIDEOCHATTED AND WAS ABLE TO SEE THE DISTAL MARKER WAS IN THE 3RD INTERCOSTAL SPACE, AND THE REPORTED BALLOON CATHETER NOT INFLATING FULLY. ESP TEAM RECOMMENDED REMOVING THE HELIUM TUBING FROM THE EXTRACORPOREAL TUBING AND ASPIRATING TO ASSESS FOR BLOOD IN THE HELIUM TUBING. ESP TEAM ALSO RECOMMENDED MANUALLY INFLATING AND DEFLATING WITH 30CC OF AIR INTO THE MALE LEUR OF THE EXTRACORPOREAL TUBING. THE SCRUB TECH FOLLOWED THE INSTRUCTIONS. THE HELIUM TUBING WAS RECONNECTED, AND CHRIS BEGAN THERAPY. THIS RESOLVED THE ISSUE. ESP TEAM COULD SEE ON THE VIDEOCHAT THAT ALL WAVEFORMS AND BLOOD PRESSURE INDICES WERE APPROPRIATE. THERE WAS NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468482 ↗MalfunctionFeb 18, 2026Inflation Problem
MalfunctionFeb 12, 2026Pacing Problem; Inappropriate Waveform
MalfunctionFeb 6, 2026Leak/Splash
(B)(6) THE CLINICAL NURSE SPECIALIST, CALLED WITH BALLOON INFORMATION FOR A PERFORATION. SHE EXPLAINED THE PATIENT NOW HAS HER 5TH BALLOON IN PLACE. (B)(6) STATED ALL THE BALLOONS WERE PLACED AXILLARY WHILE THE PATIENT AWAITS A HEART TRANSPLANT. AXILLARY DISCLAIMER WAS PROVIDED. THIS COMPLAINT IS FOR THE BALLOON PLACED (B)(6) 2025. IT HAD A BALLOON PERFORATION. THE IAB WAS DISCARDED BY STAFF. THERE WAS NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24276486 ↗MalfunctionJan 30, 2026Inability to Auto-Fill; Restricted Flow rate; Leak/Splash
MalfunctionJan 29, 2026Appropriate Device Problem Term/Code Not Available; Migration
(B)(6), AN ICU RN, CALLED INTO EMERGENCY SUPPORT PROGRAM LINE REQUESTING ASSISTANCE FOR AN UNABLE TO UPDATE TIMING MESSAGE. SHE REPORTED SHE HAD TROUBLESHOT THE MESSAGE BY FLUSHING AND ASPIRATING THE INNER LUMEN AND CHANGING OUT THE ECG ELECTRODES, WHICH DID NOT RESOLVE THE MESSAGE. SHE REPORTED THE PATIENT WAS NOT ON ANY OTHER MEDICAL DEVICES. A SCREENSHOT OF THE IABP MONITOR REVEALED AN ARTERIAL LINE WITH MILD ARTIFACT, AND THE UNABLE TO UPDATE TIMING MESSAGE WAS NO LONGER PRESENT. IT ALSO REVEALED A SIGNIFICANT AMOUNT OF ECG ARTIFACT. ESP PERSONNEL REVIEWED THE NATURE OF THE MESSAGE WITH (B)(6). A SCREENSHOT OF THE MOST RECENT CHEST XRAY (OBTAINED AT 3:00AM ON (B)(6) 2025) REVEALED THE DISTAL MARKER WAS IN THE 5TH INTERCOSTAL SPACE. ESP PERSONNEL RECOMMENDED CONSULTING WITH THE PHYSICIAN TO DISCUSS THE PLACEMENT OF THE BALLOON CATHETER AND ALSO RECOMMENDED REPLACING THE ECG ELECTRODES, PLACING DOPPLER GEL ON THE BACK OF EACH ONE, AND PLACING THE ECG ELECTRODES AS IF THEY WERE ¿HUGGING THE HEART¿ TO INCREASE CONDUCTION. (B)(6) STATED SHE WOULD CONSIDER THE RECOMMENDATIONS, AND DID NOT NEED ANY ADDITIONAL TROUBLESHOOTING ASSISTANCE. NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24206891 ↗MalfunctionJan 23, 2026Component Missing
MalfunctionJan 22, 2026Restricted Flow rate
MalfunctionJan 22, 2026Inappropriate Waveform
MalfunctionJan 16, 2026Migration
MalfunctionJan 14, 2026Restricted Flow rate; Inappropriate Waveform
IT WAS REPORTED BY THE CUSTOMER VIA EMERGENCY SUPPORT PROGRAM LINE, THAT THE INTRA-AORTIC BALLOON (IAB) SENSATION PLUS 40CCH HAD A FIBER OPTIC WAVEFORM ACCURACY ISSUE. THERE WAS SOME INDICATION OF RESTRICTION ON THE BALLOON WAVEFORM. THERE WERE NO PATIENT HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24066330 ↗MalfunctionJan 3, 2026Pacing Problem; Migration
MalfunctionDec 28, 2025Pressure Problem; Migration; Pressure Problem; Migration
IT WAS REPORTED THROUGH A DIRECT CALL FROM THE CUSTOMER TO THE EMERGENCY SUPPORT PROGRAM THAT, INTRA-AORTIC BALLOON (IAB) HAD SUPRAOPTIMAL AUGMENTATION. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23903401 ↗MalfunctionDec 28, 2025Migration; Migration
IT WAS REPORTED THROUGH A DIRECT CALL FROM THE CUSTOMER TO THE EMERGENCY SUPPORT PROGRAM THAT, INTRA-AORTIC BALLOON (IAB) THAT THE POSITION OF THE BALLOON (RADIOPAQUE TIP WAS BELOW THE 5TH INTERCOASTAL SPACE. THE ALLEGED ISSUE WAS NOT RELATED TO A DEVICE MALFUNCTION, RATHER USER ERROR (MALPOSITION OF BALLOON).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23903389 ↗MalfunctionDec 28, 2025Leak/Splash; Increase in Pressure; Gas/Air Leak; Leak/Splash; Increase in Pressure; Gas/Air Leak
MalfunctionDec 24, 2025Pacing Problem; Inappropriate Waveform; Migration; Pacing Problem; Inappropriate Waveform; Migration
IT WAS REPORTED BY THE CUSTOMER (REGISTERED NURSE) THROUGH EMERGENCY SUPPORT PROGRAM THAT WHILE USING SENSATION PLUS 7.5FR. 40CC IAB & ACCESSORIES INTRA AORTIC BALLOON (IAB), THEY REQUIRED ASSISTANCE WITH THE ECG AND ARTERIAL WAVEFORMS. A SCREENSHOT OF THE IABP MONITOR REVEALED SIGNIFICANT ARTIFACT IN THE ECG AND ARTERIAL WAVEFORMS. SCREENSHOT ALSO REVEALED THE DISTAL MARKER LOOKED TO BE NEAR THE 5TH INTERCOSTAL SPACE. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23886868 ↗MalfunctionDec 16, 2025Difficult to Flush; Obstruction of Flow; Difficult to Flush; Obstruction of Flow
IT WAS REPORTED THROUGH A DIRECT CALL FROM THE CUSTOMER TO THE EMERGENCY SUPPORT PROGRAM THAT DURING USE, INTRA-AORTIC BALLOON (IAB) HAD CLOTTED INNER LUMEN. ALUK WAS UNABLE TO FLUSH OR ASPIRATE FROM THE INNER LUMEN OF THE CATHETER. THERE WAS NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23816186 ↗MalfunctionDec 9, 2025Leak/Splash; Material Rupture; Gas/Air Leak; Leak/Splash; Material Rupture; Gas/Air Leak
IT WAS REPORTED BY THE CUSTOMER THAT WHILE USING SENSATION PLUS 40 CC INTRA AORTIC BALLOON (IAB) CATHETER, RUPTURED INSIDE PATIENT. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23753541 ↗
Other System, Balloon, Intra-Aortic And Control devices
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- CS300 Intra-Aortic Balloon Pump, English, 110V 0998-00-3023-53Datascope Corp. · System, Balloon, Intra-Aortic And Control12 deaths3,164 reports
- CARDIOSAVE HYBRID W/ E/F PLUG 0998-00-0800-55Datascope Corp. · System, Balloon, Intra-Aortic And Control20 recalls8 deaths1,686 reports
- CARDIOSAVE HYBRID, TYPE I PLUG 0998-00-0800-45Datascope Corp. · System, Balloon, Intra-Aortic And Control20 recalls5 deaths1,181 reports
- CARDIOSAVE HYBRID, TYPE G PLUG 0998-00-0800-52Datascope Corp. · System, Balloon, Intra-Aortic And Control19 recalls2 deaths1,157 reports
- SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet) 0684-00-0576-01Datascope Corp. · System, Balloon, Intra-Aortic And Control2 recalls33 deaths1,541 reports
- CARDIOSAVE RESCUE 0998-00-0800-83Datascope Corp. · System, Balloon, Intra-Aortic And Control26 recalls167 reports
- CARDIOSAVE HYBRID, 3.1 EDITION 0998-00-0800-65Datascope Corp. · System, Balloon, Intra-Aortic And Control20 recalls3 deaths456 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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