Linear 7.5Fr. 34cc IAB 0684-00-0479-01Recalls & reported problems
Datascope Corp. · Linear 7.5Fr. 34cc IAB · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Datascope Linear 7.5Fr 34cc intra-aortic balloon pump catheter, used to support the heart during critical care. The 56 reports mostly describe leaks or splashes, contamination of the device, and difficulty inflating or inserting it, along with pressure and flow alarms on the pump console. Two reports mention a death; no injuries were reported. No recalls name this device.
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
- 58
- Deaths reported
- 2
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10607567106557), received between Oct 2, 2020 and Sep 29, 2026 — classified as 2 deaths, 56 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (20 reports).
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
Most reported problems
Device problems
- Leak/Splash20
- Device Contamination with Chemical or Other Material6
- Difficult to Insert5
- Inflation Problem5
- Pressure Problem4
- Inability to Auto-Fill3
- Inappropriate Waveform3
- Restricted Flow rate3
Patient problems
- No Clinical Signs, Symptoms or Conditions52
- No Consequences Or Impact To Patient5
- Insufficient Information4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Leak/Splash
It was reported by the customer that during use of Linear 34cc balloon catheter they had a leak and blood entered the catheter. Another ballon catheter was inserted to resume therapy. No harm to the patient reported. There was no difficulty experienced inserting the Intra-Aortic Balloon (IAB) catheter. Sheath was used during insertion. Blood was first observed within the IAB catheter 5 mins after insertion.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928296 ↗MalfunctionSep 22, 2026Leak/Splash
It was reported that the physician inserted a Linear 34cc balloon catheter. Approximately five minutes after insertion, during a routine check of the machine and catheter function, blood return was observed in the tubing. The catheter was immediately removed and replaced with a new catheter. No harm to the patient reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852280 ↗MalfunctionMar 30, 2026Pacing Problem
MalfunctionFeb 15, 2026Inappropriate Waveform; Migration
IT WAS REPORTED BY THE CUSTOMER THROUGH EMERGENCY SUPPORT PROGRAM THAT THE LINEAR 34CC HAD AN AUTO R WAVE DEFLATE MESSAGE RELATED ISSUE. NURSE CALLED REQUESTING INFORMATION FOR AN AUTO R WAVE DEFLATE MESSAGE THAT APPEARED AFTER THE PATIENT¿S HEART RATE WENT FROM SINUS RHYTHM TO ATRIAL FIBRILLATION. ESP PERSONAL REVIEWED THE NATURE OF THE MESSAGE WITH NURSE. ESP PERSONAL ALSO REVIEWED A SCREENSHOT OF THE IABP MONITOR WHICH REVEALED AN ECG WITH ARTIFACT AND PACER SPIKES, AN ARTERIAL WAVEFORM USING TRANSDUCER AS WELL AS AN UNABLE TO UPDATE TIMING INFORMATIONAL MESSAGE. NURSE ASPIRATED SUCCESSFULLY AND FLUSHED IN STANDBY FOR 20 SECONDS. THIS RESOLVED THE UNABLE TO UPDATE TIMING ALARM. ESP PERSONAL 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. ESP PERSONAL REVIEWED A SCREENSHOT OF THE PREVIOUS CHEST XRAY TAKEN AND THE DISTAL MARKER APPEARED TO BE IN BETWEEN THE 4TH AND 5TH INTERCOSTAL SPACE. ESP PERSONAL RECOMMENDED OBTAINING A NEW CHEST XRAY AND CONSULTING THE PHYSICIAN TO DISCUSS PLACEMENT. NURSE SENT A SCREENSHOT OF THE NEW CHEST XRAY WHICH REVEALED TH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24341421 ↗DeathNov 28, 2025Inability to Auto-Fill; Inability to Auto-Fill
IT WAS REPORTED DURING INTRA-AORTIC BALLOON THERAPY THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAS ERROR MESSAGE: AUTOLOAD FAILED. THE PATIENT HAS DIED.
Patient problems: Insufficient Information
MAUDE report 23670141 ↗MalfunctionNov 21, 2025Increase in Pressure; Increase in Pressure
MalfunctionNov 6, 2025Signal Artifact/Noise; Difficult to Flush; Migration or Expulsion of Device; Pacing Problem; Infusion or Flow Problem; Appropriate Device Problem Term/Code Not Available; Migration; Signal Artifact/Noise; Difficult to Flush; Migration or Expulsion of Device; Pacing Problem; Infusion or Flow Problem; Appropriate Device Problem Term/Code Not Available; Migration
THE COMPLAINT WAS RECEIVED THROUGH A DIRECT CALL FROM THE CUSTOMER TO THE EMERGENCY SUPPORT PROGRAM. IT WAS REPORTED THAT DURING USE CUSTOMER CALLED FOR SUPPORT WITH AN UNABLE TO UPDATE TIMING ALARM ON A CARDIOSAVE, TROUBLESHOOTING REVEALED A CONSOLE SCREEN OF THE INTRA-AORTIC BALLOON (IAB) REVEALED ARTIFACT PRESENT IN THE ECG, WHIP PRESENT IN THE ARTERIAL WAVEFORM AND IT WAS ALSO REPORTED THAT IAB CATHETER WAS UNABLE TO ASPIRATE THE INNER LUMEN. NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23490501 ↗MalfunctionNov 4, 2025Restricted Flow rate; Restricted Flow rate
MalfunctionJul 21, 2025Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED RESTRICTION ALARM ON AN INTRA-AORTIC BALLOON (IAB) CATHETER. ALTHOUGH THE ALARM WAS NOT ACTIVE AT THE TIME OF THE CALL, CUSTOMER MENTIONED THAT IT HAD OCCURRED WITHIN THE PAST FEW HOURS. CUSTOMER SUSPECTED THE PATIENT¿S LARGE PANNUS MIGHT BE CONTRIBUTING TO THE RESTRICTION. CUSTOMER CALLED TO SEEK GUIDANCE ON HOW TO MANAGE THE ALARM AND PREVENT FUTURE OCCURRENCES. NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22554068 ↗MalfunctionApr 22, 2025Inflation Problem; Inflation Problem
IT WAS REPORTED THAT INTRA AORTIC BALLOON DID NOT INFLATE AFTER INSERTION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21882495 ↗MalfunctionMar 28, 2025Fluid/Blood Leak; Leak/Splash; Device Contamination with Body Fluid; Fluid/Blood Leak; Leak/Splash; Device Contamination with Body Fluid
IT WAS REPORTED THAT INTRA AORTIC BALLOON (IAB) HAD A RUPTURE. THERE WAS NO HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21716178 ↗MalfunctionFeb 14, 2025Inflation Problem; Pressure Problem; Inflation Problem; Pressure Problem
IT WAS REPORTED THAT INITIALLY THE LABELS INSIDE AND OUTSIDE THE BOX OF THE BALLOON CATHETER INTRA-AORTIC BALLOON (IAB) DID NOT MATCH. HOWEVER, IT WAS LATER CLARIFIED THAT THERE WAS NO LABELLING ISSUE; INSTEAD, THE PROBLEM WAS WITH THE CATHETER ITSELF. NO HARM TO THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21383435 ↗MalfunctionJan 28, 2025Material Rupture; Material Rupture
MalfunctionDec 5, 2024Leak/Splash; Difficult to Remove; Gas/Air Leak; Leak/Splash; Difficult to Remove; Gas/Air Leak
IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON WAS INSERTED ON (B)(6) 2024 AT 1910. THE FOLLOWING MORNING AT 0615 ((B)(6) 2024), THERE WAS A GAS LEAK ALARM AND BLOOD WAS OBSERVED INSIDE THE HELIUM TUBING. THE DOCTOR WAS INFORMED AND THE PUMP WAS SWITCHED OFF AT 0630. DUE TO THE RESISTANCE, THE IAB COULD NOT BE REMOVED. WITHIN 20 MINUTES, THE PATIENT WAS SENT FOR SURGERY TO REMOVE THE IAB. IT WAS AT THIS POINT IAB RUPTURE WAS OBSERVED. THERE IS NO NEW IAB INSERTED AS THE PATIENT WAS FINE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20854126 ↗MalfunctionDec 3, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AFTER APPROXIMATELY SIX DAYS OF INTRA-AORTIC BALLOON (IAB) THERAPY, A "GAS GAIN IN IAB CIRCUIT" ALARM OCCURRED. VERIFIED FROM THE LOGS THAT INDEED ON 12NOV2024, 4:33 AM, THE MACHINE DID PROMPT IT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20836142 ↗MalfunctionNov 27, 2024Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT DURING INSERTION, THE GUIDEWIRE COULD NOT BE INSERTED THROUGH THE INTRA-AORTIC BALLOON (IAB). UPON CLOSE INSPECTION, A KINK IN THE BALLOON IS OBSERVED. A NEW IAB WAS INSERTED TO CONTINUE THERAPY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20795431 ↗MalfunctionNov 13, 2024Leak/Splash; Leak/Splash
MalfunctionAug 13, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AFTER APPROXIMATELY 2.5 DAYS OF INTRA-AORTIC BALLOON (IAB) THERAPY, BLOOD WAS SEEN IN THE EXTRACORPOREAL TUBING AND THE CONSOLE GENERATED AN IAB CATHETER RESTRICTION ALARM. PATIENT WAS MANAGED WITH INOTROPES. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19973400 ↗MalfunctionJul 17, 2024Restricted Flow rate; Pressure Problem; Restricted Flow rate; Pressure Problem
IT WAS REPORTED THAT UPON INSERTION OF THE INTRA-AORTIC BALLOON (IAB), IT WAS UNABLE TO AUGMENT AND A CATHETER RESTRICTION ALARM WAS GENERATED. THERE WERE NO KINKS FOUND ALONG THE IAB CATHETER OR EXTRACORPOREAL HELIUM TUBING. A NEW IAB WAS THEN INSERTED TO PROVIDE THERAPY WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19760993 ↗MalfunctionJul 11, 2024Break; Break
MalfunctionFeb 6, 2024Leak/Splash; Leak/Splash
MalfunctionJan 11, 2024Leak/Splash; Leak/Splash
MalfunctionNov 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING THERAPY, THE INTRA-AORTIC BALLOON (IAB) DID NOT FUNCTION PROPERLY. IT IS UNCLEAR WHAT MALFUNCTION OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. A NEW 40CC IAB WAS THEN INSERTED TO CONTINUE THERAPY WITHOUT FURTHER ISSUE. IT WAS NOTED THAT THIS PROLONGED SURGICAL TIME. HOWEVER, THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18092445 ↗DeathSep 6, 2023Inability to Auto-Fill; Inflation Problem; Inability to Auto-Fill; Inflation Problem
IT WAS REPORTED THAT AN INTRA-AORTIC BALLOON (IAB) WAS BEING INSERTED TO ASSIST WITH WEANING THE PATIENT FROM BYPASS FOLLOWING A VALVE PROCEDURE. DURING THERAPY, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) GENERATED AN AUTOFILL FAILURE ALARM AND THE IAB WOULD NOT INFLATE. A NEW IAB WAS INSERTED BUT THE SAME ISSUE OCCURRED. AT THE TIME OF ATTEMPTING TO INITIATE THERAPY, IT WAS NOTED THAT THE PATIENT HAD ADEQUATE ELECTROCARDIOGRAM (EKG) SIGNAL TO THE IABP AND FLUID-FILLED TRANSDUCER WAS SET UP. THERE WERE NOT ANY SIGNIFICANT ISSUES WITH INSERTION. THEY DID NOT PERFORM A MANUAL FILL AT THE TIME OF INITIATION FOR EITHER IAB AND THEY DID NOT ATTEMPT TO USE ANOTHER IABP. HOWEVER, THE TECHNICIAN DID SEPARATE THE SECOND CATHETER FROM THE HELIUM TUBING AND FELT HELIUM FLOWING OUT OF THE HELIUM EXTENDER TUBING. IT WAS ALSO NOTED THAT WHEN THE SECOND IAB WAS REMOVED, THERE WAS DRIED BLOOD OBSERVED ON THE CATHETER AND WHEN INFLATION WAS ATTEMPTED IT WAS SOMEWHAT STUCK TOGETHER. FOLLOWING THE FAILURE TO INITIATE IAB SUPPORT, THE PATIENT WAS THEN PLACED ON EXTRACORPOREAL LIFE SUPPORT (ECLS) AND TAKEN FROM THE OPERATING ROOM (OR) FOR A SHORT PERIOD OF TIME. BLEEDING WAS SUSPECTED AS THE PATIE
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17693442 ↗MalfunctionAug 1, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, A LEAK OCCURRED AND BLOOD BACKED INTO THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP). IT WAS ALSO NOTED THAT THE IABP HAD GENERATED A LOW AUGMENTATION ALARM. A NEW IAB WAS INSERTED TO CONTINUE THERAPY FOR THREE DAYS. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED. THIS REPORT IS FOR THE IAB USED IN THIS EVENT. A SEPARATE REPORT HAS BEEN SUBMITTED FOR THE CARDIOSAVE IABP UNDER MFG REPORT NUMBER: 2249723-2023-03275.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17435342 ↗
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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
- 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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