TRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIES 0684-00-0607Recalls & reported problems
Datascope Corp. · TRANS-RAY PLUS 7.5Fr 35cc IAB WITH 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 Trans-Ray Plus intra-aortic balloon is a balloon catheter that helps the heart pump blood. Its 149 reports describe sensor problems, difficult insertion, and fluid leaks, and some mention alarms during use. The reports include 1 death and 1 injury. One recall names this device and is open, started in June 2023, over a part that may break off during insertion and damage arteries.
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
- 157
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 157 adverse event reports that list this exact device (DI 10607567111711), received between Aug 11, 2022 and Sep 18, 2026 — classified as 1 death, 1 injury, 155 malfunctions.
The most frequently reported specific device problem is “Device Sensing Problem” (29 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.
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-2218-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Sensing Problem29
- Optical Problem25
- Difficult to Insert21
- Leak/Splash21
- Fluid/Blood Leak14
- Material Deformation13
- Material Rupture11
- Migration8
Patient problems
- No Clinical Signs, Symptoms or Conditions151
- Insufficient Information14
- Myocardial Infarction1
Recent adverse event reports
The 25 most recent of 157 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Leak/Splash
It was reported that blood was observed within the extender tubing during clinical use of a TransRay Plus 35cc balloon catheter. No blood was entering the concomitant IABP unit. As the patient remained in stable condition, IABP therapy was completed without further issues. No harm to the patient was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50815794 ↗MalfunctionSep 16, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791685 ↗MalfunctionSep 14, 2026Leak/Splash
It was reported that during use of TransRay Plus 35cc balloon catheter a blood clot was observed inside the gas tubing; therefore, the balloon was removed. As the patient's condition had improved, therapy was discontinued without replacing the balloon catheter with a new one. No adverse effect on the patient was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50751086 ↗MalfunctionSep 8, 2026Inflation Problem; Obstruction of Flow
It was reported by the customer that after the TransRay Plus 35cc Intra-Aortic Balloon (IAB) catheter insertion, pumping was initiated; however, an "IAB Check Required" alarm occurred. Angiography confirmed that the distal side of the balloon was not inflating. Subsequently, a syringe was used to manually unwrap the balloon, and the catheter was reconnected to the device and pumping was restarted. However, it was again confirmed that the distal side of the balloon was not inflating. At this time, the balloon internal pressure waveform displayed on the device was rectangular. As the patient's condition remained stable, the procedure was concluded without replacing the IAB. No harm to the patient was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50661844 ↗MalfunctionSep 1, 2026Signal Artifact/Noise; Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50539970 ↗MalfunctionAug 18, 2026Inappropriate Waveform; Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50300420 ↗MalfunctionAug 3, 2026Break; Failure to Calibrate; Deformation Due to Compressive Stress; Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50113545 ↗MalfunctionJul 15, 2026Pacing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE TRANSRAY PLUS 35CC WAS USED. AFTER THE CATHETER WAS INSERTED, THE OPTICAL SENSOR PRESSURE WAS NOT OUTPUT AND AN "IAB OPTICAL SENSOR MALFUNCTION" ALARM SOUNDED. THE DEVICE MODULE WAS CHECKED BUT NO PROBLEMS WERE FOUND. A BROKEN OPTICAL SENSOR ON THE CATHETER SIDE WAS SUSPECTED, SO IT WAS REPLACED WITH A 35CC ONE OF THE SAME SIZE. NO HARM TO THE PATIENT WAS REPORTED. INFECTIOUS DISEASE WAS REPORTED TO THE PATIENT, INFECTION NOT RELATED TO OUR DEVICE. THERE WERE NO DIFFICULTIES DURING INSERTION. THERE WERE NO NOTICEABLE DEFECTS IN THE BALLOON FIBER OPTICS. CONDITION OF AORTA WAS NORMAL. BALLOON WAS INSERTED ON FEMORAL ARTERY USING TERUMO INSERTION KIT. PUMP WAS WORKING CORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25822204 ↗MalfunctionJun 2, 2026Material Deformation; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED BY THE CUSTOMER THAT DURING USE THE TRANSRAY PLUS 35CC INTRA-AORTIC BALLOON (IAB) FREQUENTLY TRIGGERED ¿CHECK IAB CATHETER¿. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25357840 ↗MalfunctionApr 20, 2026Leak/Splash; Material Rupture
MalfunctionApr 20, 2026Difficult to Flush; Obstruction of Flow
MalfunctionApr 15, 2026Restricted Flow rate; Material Deformation
IT WAS REPORTED THAT THE TRANSRAY PLUS 35CC INTRA AORTIC BALLOON (IAB) HAD A CHECK IAB CATHETER (FLOW RESTRICTION) ALARM. THERE WERE NO PATIENT HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24882756 ↗MalfunctionApr 14, 2026Device Sensing Problem
IT WAS REPORTED THAT, WHILE USING THE TRANS-RAY PLUS 7.5FR 35CC INTRA-AORTIC BALLOON PUMP (IABP), A SENSOR MALFUNCTION PREVENTED ITS USE, AND THE CATHETER HAD TO BE REPLACED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24869525 ↗MalfunctionApr 14, 2026Difficult to Insert; Device Sensing Problem; Material Deformation; Positioning Problem
IT WAS REPORTED THAT DURING USE, THE TRANSRAY PLUS 35CC INTRA AORTIC BALLOON (IAB) HAD FIBER OPTIC SENSOR FAILURE AND DIFFICULT OR UNABLE TO INSERT IAB KINK.THERE WERE NO PATIENT HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24868346 ↗MalfunctionMar 20, 2026Device Sensing Problem
MalfunctionMar 18, 2026Difficult to Insert; Material Deformation
MalfunctionMar 16, 2026Difficult to Insert
MalfunctionMar 10, 2026Device Sensing Problem
IT WAS REPORTED DURING USE, THE TRANSRAY PLUS 35CC INTRA AORTIC BALLOON (IAB) MALFUNCTIONED. "IAB OPTICAL SENSOR MALFUNCTION" ALARM DISPLAYED. THERE WERE NO PATIENT HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24555357 ↗MalfunctionMar 2, 2026Device Sensing Problem
IT WAS REPORTED THAT THE TRANSRAY PLUS35CC HAD OPTICAL SENSOR MALFUNCTION DURING USE. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24488788 ↗MalfunctionFeb 25, 2026Difficult to Insert
IT WAS REPORTED THAT DURING USE, THE TRANSRAY PLUS 35CC INTRA-AORTIC BALLOON (IAB) MALFUNCTIONED. IT WAS REPORTED THE PROBLEM WITH ADVANCING CATHETER THROUGH THE ORIGINAL GUIDEWIRE. THERE WAS NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24441683 ↗MalfunctionFeb 24, 2026Pacing Problem; Device Sensing Problem
MalfunctionFeb 12, 2026Material Deformation
IT WAS REPORTED THAT DURING INSERTION OF THE TRANSRAY PLUS 35CC CATHETER SHAFT KINKED AND BECAME UNUSABLE. THERE IS NO HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320849 ↗MalfunctionFeb 9, 2026Pacing Problem; Device Sensing Problem
MalfunctionFeb 9, 2026Difficult to Insert
IT WAS REPORTED BY THE CUSTOMER THAT AFTER INSERTING THE SHEATH, THE CATHETER WAS INSERTED, BUT DUE TO SOME TORTUOSITY OF THE BLOOD VESSEL, IT WAS NOT POSSIBLE TO INSERT IT AROUND THE AORTIC BIFURCATION. WHEN A NEW TRP3546 WAS INSERTED, IT WAS POSSIBLE TO INSERT IT WITHOUT RESISTANCE. IT IS THOUGHT THAT THERE WAS SOME PROBLEM WITH THE CATHETER. THERE WAS NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24290082 ↗MalfunctionFeb 9, 2026Inability to Auto-Fill; Failure to Calibrate
IT WAS REPORTED DURING USE THAT THE INTRA AORTIC BALLOON (IAB) DISPLAYED AUTO FILL ERROR AND CALIBRATION NOT POSSIBLE ALARM MESSAGES. THERE WAS NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24288775 ↗
Other System, Balloon, Intra-Aortic And Control devices
- CARDIOSAVE HYBRID, TYPE B PLUG 0998-00-0800-53Datascope Corp. · System, Balloon, Intra-Aortic And Control21 recalls39 deaths10,316 reports
- 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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