Linear 7.5Fr. 40cc IAB 0684-00-0480-01Recalls & reported problems
Datascope Corp. · Linear 7.5Fr. 40cc IAB · 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 Linear intra-aortic balloon has 167 reports, including 4 deaths and 4 injuries. Many reports describe leaks, gas loss alarms, and balloons that were hard to insert or inflate, along with some balloon perforations and mismatched tubing. The device has 1 open recall, from June 2023, over a part that can break inside the sheath during insertion, which may damage blood vessels and delay treatment. Reports fell from 32 in the prior 12 months to 9 in the latest 12 months.
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
- 168
- Deaths reported
- 4
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 168 adverse event reports that list this exact device (DI 10607567106564), received between Sep 23, 2020 and Sep 22, 2026 — classified as 4 deaths, 5 injuries, 159 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (50 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-2223-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash50
- Inflation Problem19
- Difficult to Insert17
- Material Deformation16
- Inappropriate Waveform11
- Gas/Air Leak10
- Inability to Auto-Fill10
- Off-Label Use9
Patient problems
- No Clinical Signs, Symptoms or Conditions144
- No Consequences Or Impact To Patient18
- Insufficient Information6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Cardiac Arrest1
- Death1
- Fever1
- Hemodynamic instability1
Recent adverse event reports
The 25 most recent of 168 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Fluid/Blood Leak; Difficult to Remove; Material Rupture
It was reported that brownish fluid was observed in the helium tubing following insertion of the Linear 7.5Fr. 40cc Intra-Aortic Balloon (IAB) catheter in the intensive care unit (ICU). The fluid became blood-stained over a period of approximately two hours, and the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) was stopped. The user suspected rupture of the balloon, and the IAB catheter was surgically removed in the operating room (OR) after the patient was transitioned to extracorporeal membrane oxygenation (ECMO) support.
Patient problems: Insufficient Information
MAUDE report 50851394 ↗MalfunctionAug 28, 2026Inflation Problem; Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50496371 ↗MalfunctionApr 7, 2026Gas/Air Leak
MalfunctionMar 9, 2026Leak/Splash; Material Rupture
IT WAS REPORTED BY THE CUSTOMER THROUGH EMERGENCY SUPPORT PROGRAM THAT THE LINEAR 40CC HAD BALLOON PERFORATION DURING USE. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24544207 ↗DeathFeb 24, 2026Inability to Auto-Fill; Material Rupture
MalfunctionJan 9, 2026Pacing Problem; Obstruction of Flow
IT WAS REPORTED BY THE CUSTOMER (REGISTERED NURSE) THROUGH EMERGENCY SUPPORT PROGRAM THAT WHILE USING LINEAR 7.5FR. 40CC IAB INTRA AORTIC BALLOON (IAB), DOES NOT HAVE AN AP ON THE SCREEN. ATTEMPTS AT ASPIRATION AND FLUSH IN STANDBY REVEALS THAT THE INNER LUMEN IS CLOTTED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24017700 ↗MalfunctionJan 8, 2026Leak/Splash; Gas/Air Leak
USER CALLED INTO EMERGENCY SUPPORT PROGRAM LINE TO REQUEST SUPPORT WITH AN INTRA-AORTIC BALLOON(IAB) GAS LOSS ALARM. (B)(6), A CARDIO FELLOW, STATED THE NURSES HAD CHANGE OUT THE PUMP; HOWEVER, THE 2ND PUMP CONTINUED TO ALARM GAS LOSS ALSO. WHEN ASKED, (B)(6) STATED THEY WERE DISCONNECTING THE HELIUM TUBING TO RESOLVE THE GAS LOSS ALARM. SHE AND ESP PERSONNEL PERFORMED PROPER TROUBLESHOOTING: VERIFY THE HELIUM TUBING HAD NO BLOOD OR DISCOLORATION. PRESS THE IAB FILL KEY FOR 2-3 SECONDS, PRESS START AND CHECK THE HELIUM TUBING AGAIN. THE PUMP RESUMED WITHOUT ISSUE. WHILE ESP PERSONNEL AND (B)(6) WERE DISCUSSING THE NATURE OF THIS ALARM AND DIFFERENT CLINICAL POSSIBILITIES, THE PUMP ALARMED GAS LOSS AGAIN. ESP PERSONNEL AND (B)(6) CHECK FOR BLOOD OR DISCOLORATION IN THE HELIUM TUBING, TURN DOWN THE AUGMENTATION BY 2 LEVELS TO 8 OUT OF 10 BARS, PRESS THE IAB FILL KEY FOR 2-3 SECONDS, PRESS START, AND CHECK THE HELIUM TUBING AGAIN. THE PUMP AGAIN STARTED WITHOUT ISSUE. THERE WAS NO OBVIOUS CLINICAL EXPLANATION FOR THE ALARM AT THAT TIME. ESP PERSONNEL EXPLAINED IF THE PUMP CONTINUED TO ALARM GAS LOSS, THEN THERE WAS MOST LIKELY AN ISSUE WITH THE BALLOON. ESP PERSONNEL ADVISED TO GO AHE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24001692 ↗MalfunctionDec 29, 2025Difficult to Flush; Difficult to Insert; Obstruction of Flow; Difficult to Flush; Difficult to Insert; Obstruction of Flow
IT WAS REPORTED BY THE CUSTOMER THAT THE INTRA-AORTIC BALLOON (IAB) PRESSURE TUBING INCLUDED IN THE INSERTION KIT WAS OBSTRUCTED, RESULTING IN THE INABILITY TO FLUSH THE LINE. THE ISSUE WAS RELATED TO A BLOCKAGE IN THE PRESSURE TUBING WITHIN THE INSERTION KIT, NOT THE IAB CATHETER ITSELF. THE PROBLEM WAS IDENTIFIED AT THE TIME OF INSERTION, AND THE AFFECTED TUBING WAS REPLACED PRIOR TO THE INITIATION OF THERAPY. FOLLOWING THE REPLACEMENT, THERAPY PROCEEDED NORMALLY, AND THE SAME IAB CATHETER REMAINED IN USE FOR APPROXIMATELY FOUR DAYS BEFORE REMOVAL. IT WAS MENTIONED NO NEW IAB INSERTED TO CONTINUE THERAPY, ONLY THE BLOCKED PRESSURE TUBING WAS REPLACED. THE IAB CATHETER WAS NOT EXCHANGED, AND THERAPY WAS CONTINUED USING THE SAME CATHETERTHERE WAS NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23904527 ↗MalfunctionDec 8, 2025Component Misassembled; Component Misassembled
IT WAS REPORTED BY CUSTOMER THAT DURING USE OF INTRA AORTIC BALLOON, IT WAS FOUND THAT THE INTERFACE OF THE BALLOON EXTENSION TUBE DID NOT MATCH. CHANGED ANOTHER AND FOUND SAME PROBLEM. THEN THE CUSTOMER CHECKED INVENTORY AND FOUND ANOTHER ONE. THESE THREE IAB ARE FROM THE SAME LOT. NO HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23738589 ↗MalfunctionNov 20, 2025Restricted Flow rate; Leak/Splash; Difficult to Advance; Restricted Flow rate; Leak/Splash; Difficult to Advance
IT WAS REPORTED THAT BALLOON CATHETER INTRA-AORTIC BALLOON (IAB) WAS INSERTED SUCCESSFULLY. LATER THAT EVENING, NURSING STAFF OBSERVED BLOOD REFLUX IN THE CATHETER, RAISING SUSPICION OF A POSSIBLE IAB RUPTURE. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602818 ↗MalfunctionOct 23, 2025Obstruction of Flow; Obstruction of Flow
MalfunctionOct 20, 2025Material Deformation; Material Deformation
MalfunctionOct 15, 2025Break; Break
IT WAS REPORTED BY CUSTOMER THAT, THE DILATOR TIP OF LINEAR 40 CC INTRA-AORTIC BALLOON (IAB) DILATOR TIP GOT DESTROYED OVER WIRE WHILE PUSHING INTO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23297324 ↗MalfunctionOct 15, 2025Inability to Auto-Fill; Leak/Splash; Gas/Air Leak; Inability to Auto-Fill; Leak/Splash; Gas/Air Leak
IT WAS REPORTED THAT PATIENT WITH AXILLARY IAB ALARMING MULTIPLE LEAK IN IAB CIRCUIT AND AUTOFILL FAILURES. NO BLOOD IN TUBING WAS REPORTED AND CATHETER WAS REPOSITIONED DUE TO RETRACTIONS SOMETIMES 1-2 TIMES PER DAY. NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23288155 ↗MalfunctionOct 15, 2025Leak/Splash; Leak/Splash
MalfunctionOct 15, 2025Restricted Flow rate; Fluid/Blood Leak; Restricted Flow rate; Fluid/Blood Leak
IT WAS REPORTED THAT BALLOON CATHETER INTRA-AORTIC BALLOON (IAB) HAD ALARM OF AB CATHETER RESTRICTION. THE RN OBSERVED BLOOD IN THE TUBING AND IMMEDIATELY PLACED THE PUMP IN STANDBY MODE AND CLAMPED THE TUBING. NO BLOOD ENTERED THE PUMP. THE CATHETER WAS SUBSEQUENTLY REMOVED AND REPLACED WITH A NEW ONE. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23277312 ↗MalfunctionAug 26, 2025Leak/Splash; Leak/Splash
MalfunctionAug 5, 2025Inappropriate Waveform; Inappropriate Waveform
IT WAS REPORTED BY CUSTOMER THAT DURING IAB (INTRA AORTIC BALLOON) THERAPY, AN AUGMENTATION ALARM OCCURED, UNABLE TO UPDATE TIMING ALARM, AND ARTERIAL LINE ACQUISITION ON A CS300. NO PATIENT HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22710987 ↗MalfunctionJul 31, 2025Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT DURING THE INSERTION OF LINEAR 40 CC CATHETER EXCESSIVE RESISTANCE WAS ENCOUNTERED, PREVENTING ADVANCEMENT TO THE INTENDED POSITION. NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22679395 ↗MalfunctionJul 23, 2025Pacing Problem; Appropriate Device Problem Term/Code Not Available; Pacing Problem; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING INTRA AORTIC BALLOON (IAB) THERAPY THERE WAS AN ISSUE OF UNABLE TO UPDATE TIMING AND ARTERIAL WAVEFORM QUALITY. THERE WAS PATIENT INVOLVEMENT BUT NO HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22574017 ↗MalfunctionJul 15, 2025Fluid/Blood Leak; Leak/Splash; Off-Label Use; Fluid/Blood Leak; Leak/Splash; Off-Label Use
IT WAS REPORTED THAT DURING INTRA AORTIC BALLOON (IAB) THERAPY THERE WAS BLOOD SEEN IN THE HELIUM TUBING. THE IAB HAD BEEN INDWELLING FOR 35 DAYS. THE IAB WAS REPLACED WITH ANOTHER IAB. THERE WAS NO HARM OR CHANGE IN PATIENT STATUS DUE TO THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22507958 ↗MalfunctionJul 3, 2025Device Sensing Problem; Device Sensing Problem
MalfunctionJun 30, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE NURSE CALLED TO INFORM THAT A 40 CC LINEAR INTRA-AORTIC BALLOON HAD BEEN USED ON THE PATIENT. WHILE THE DOCTOR HAD INSERTED THE BALLOON AND WAS TRYING TO DRAW BLOOD FROM, THEY POSITION, THE BALLOON COULD NOT DRAW BLOOD. THE DOCTOR MOVED THE POSITION OF THE BALLOON AND TRIED TO DRAW BLOOD AGAIN BUT FOUND THAT BLOOD COULD NOT BE DRAWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22356002 ↗MalfunctionJun 20, 2025Break; Break
IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE GUIDEWIRE OF 40CC LINEAR CATHETER WAS FOUND DAMAGED AND ANOTHER PRODUCT HAD TO BE OPENED. THE SECOND WAS PLACED WITHOUT ISSUE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22294772 ↗MalfunctionJun 10, 2025Inability to Auto-Fill; Leak/Splash; Off-Label Use; Inability to Auto-Fill; Leak/Splash; Off-Label Use
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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