MEGA 8Fr. 50cc IAB (with Statlock) 0684-00-0296-01Recalls & reported problems
Datascope Corp. · MEGA 8Fr. 50cc IAB (with Statlock) · 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 MEGA intra-aortic balloon is a catheter with a balloon that is pumped in the aorta to support the heart. Its 141 reports often describe leaks, difficult insertion, and clotted lines or gas-loss alarms. The reports include 5 deaths and 8 injuries. 1 recall, still open, began in June 2023 over a dilator that may break inside the sheath during insertion.
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
- 141
- Deaths reported
- 5
- Injuries reported
- 8
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 141 adverse event reports that list this exact device (DI 10607567108001), received between Aug 28, 2020 and May 4, 2026 — classified as 5 deaths, 8 injuries, 128 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (34 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-2220-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash34
- Difficult to Insert20
- Material Deformation14
- Pressure Problem11
- Difficult to Flush8
- Fluid/Blood Leak8
- Inflation Problem8
- Gas/Air Leak6
Patient problems
- No Clinical Signs, Symptoms or Conditions121
- No Consequences Or Impact To Patient8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Death3
- Insufficient Information3
- No Patient Involvement3
- Injury2
- Low Blood Pressure/ Hypotension2
Recent adverse event reports
The 25 most recent of 141 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2026Obstruction of Flow; Optical Obstruction
THE COMPLAINT WAS RECEIVED THROUGH A DIRECT CALL FROM THE CUSTOMER (REGISTERED NURSE) TO THE EMERGENCY SUPPORT PROGRAM. IT WAS REPORTED THAT WHILE USING MEGA 50CC INTRA AORTIC BALLOON (IAB), THE REPORTER CALLED FOR ASSISTANCE FOR A CLOTTED INNER LUMEN ON A NON FIBEROPTIC BALLOON CATHETER VIA AXILLARY INSERTION. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25066149 ↗MalfunctionApr 13, 2026Pacing Problem
THE COMPLAINT WAS RECEIVED THROUGH A DIRECT CALL FROM THE CUSTOMER TO THE EMERGENCY SUPPORT PROGRAM. NO HARM OR INJURY TO THE PATIENT WAS REPORTED. AN RN IN CVICU CALLS WITH TO ASK ABOUT HER PATIENT GOING IN AND OUT OF A-FIB AND SVT, NOTING THAT THE PUMP WOULD FLAT LINE INTERMITTENTLY FOR 3 TO 4 BEATS. SHE STATED THE PATIENT WAS IN SEMI AUTO MODE, AT A RATIO OF 1:2, ON A CARDIOSAVE CONSOLE. ESP TEAM MEMBER ALSO ASKED WHY THE PATIENT WAS IN SEMI AUTO MODE SHE REPORTED THAT THE PATIENT WAS RECEIVED IN THAT SETTING AND THAT SHE WOULD NEED TO MAKE A CALL TO CHANGE IT. UPON REVIEWING THE IMAGE, ESP TEAM MEMBER NOTED A POOR QUALITY ECG, AN ELEVATED HEART RATE, AND A DAMPED ARTERIAL WAVEFORM WITH ASSISTED PRESSURES GREATER THAN UNASSISTED PRESSURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24853840 ↗MalfunctionApr 4, 2026Restricted Flow rate; Leak/Splash
(B)(6) AN ICU RN, CALLED INTO THE EMERGENCY SUPPORT PROGRAM LINE REQUESTING INSTRUCTIONS TO PRINT AN ALARM AND TRIGGER LOG. ESP PERSONNEL PROVIDED THE STEPS AND SHE SUCCESSFULLY PRINTED THE REQUESTED LOG. SHE REVIEWED THE ALARM LOG AND STATED THE LAST TWO ALARMS WERE CATHETER RESTRICTION AND GAS LOSS. THERE WAS NO CURRENT ALARM AT THE TIME OF THE CALL. ESP PERSONNEL REVIEWED THE NATURE OF BOTH ALARMS AND THE PROPER TROUBLESHOOTING FOR EACH. (B)(6) VERIFIED THERE WAS NO BLOOD, DISCOLORATION, OR FLAKES IN THE HELIUM TUBING AND THAT ALL CONNECTIONS WERE SECURED. SHE REPORTED THE PATIENT HAD AN AXILLARY INSERTED BALLOON CATHETER. AN AXILLARY DISCLAIMER WAS PROVIDED. ESP PERSONNEL AND (B)(6) REVIEWED PROBABLE CAUSES THAT COULD TRIGGER BOTH OF THOSE ALARMS. NO PATIENT HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24785011 ↗MalfunctionMar 19, 2026Leak/Splash; Gas/Air Leak
MalfunctionMar 11, 2026Leak/Splash; Pacing Problem; Failure to Unfold or Unwrap; Material Twisted/Bent
IT WAS REPORTED BY THE CUSTOMER VIA EMERGENCY SUPPORT PROGRAM LINE, THAT THE MEGA 50 CC INTRA AORTIC BALLOON (IAB) HAD A GAS LOSS ALARM AND 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 24567297 ↗MalfunctionMar 6, 2026Difficult to Insert
MalfunctionFeb 17, 2026Difficult to Flush; Pacing Problem
IT WAS REPORTED BY HOSPITAL THAT MEGA 8FR 50CC IAB THAT A STRANGE WAVE FORM NOTED WHEN STARTED. UNABLE TO WITHDRAW BLOOD FROM LINE. NOT ABLE TO FLUSH. NO HARM AND INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24364544 ↗MalfunctionJan 30, 2026Restricted Flow rate; Obstruction of Flow
IT WAS REPORTED BY THE CUSTOMER VIA THE EMERGENCY SUPPORT PROGRAM LINE THAT THE MEGA 50 CC INTRA AORTIC BALLOON (IAB) HAD ITS INNER LUMEN OCCLUDED WITH CLOT WHILE IN USE. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24219694 ↗MalfunctionJan 29, 2026Positioning Problem
IT WAS REPORTED BY THE CUSTOMER THAT DURING USE THE MEGA 50CC INTRA AORTIC BALLOON (IAB) CATHETER COULD NOT ADVANCE THROUGH THE 50CC SUPPLIED INSERTION KIT. A SECOND MEGA 50CC CATHETER WAS OPENED AND WAS PLACED SUCCESSFULLY THROUGH A 9FR SHEATH WITHOUT INCIDENT. THERE WAS NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24207340 ↗MalfunctionJan 12, 2026Pacing Problem; Migration
THE COMPLAINT WAS RECEIVED THROUGH A DIRECT CALL FROM THE CUSTOMER (REGISTERED NURSE) TO THE EMERGENCY SUPPORT PROGRAM. IT WAS REPORTED THAT WHILE USING MEGA 8FR. 50CC IAB (WITH STATLOCK) INTRA AORTIC BALLOON (IAB) HAD A NOTCH ON THE ARTERIAL WAVEFORM. A SCREENSHOT OF THE IABP MONITOR REVEALED THE PUMP WAS IN 1:2 FREQUENCY AND IN AUTO-MODE, WITH A WHIPPED-LIKE ARTERIAL WAVEFORM USING THE TRANSDUCER AS THE AP SOURCE. NURSE STATED THE PRIMARY RN HAD FLUSHED THE LINE RECENTLY, BUT IT DID NOT HELP WITH THE ARTIFACT. (B)(6) STATED THE PLACEMENT WAS VERIFIED BY A CHEST XRAY THIS MORNING. NURSE DID NOT WANT TO ASPIRATE THE INNER LUMEN. ESP TEAM MEMBER REQUESTED A SCREENSHOT OF THE CHEST XRAY TO ENSURE THE DISTAL MARKER WAS LOCATED IN BETWEEN THE SECOND AND THIRD INTERCOSTAL SPACE. (B)(6) HAD TO QUICKLY GET OFF THE PHONE TO PRIORITIZE PATIENT CARE, BUT NURSE STATED SHE WOULD FOLLOW-UP WITH THE MOST RECENT CHEST XRAY SCREENSHOT WHICH REVEALED THE DISTAL MARKER WAS LOCATED BETWEEN THE 4TH AND 5TH INTERCOSTAL SPACE. ESP TEAM MEMBER EXPLAINED TO (B)(6) GETINGE¿S RECOMMENDATION OF THE DISTAL MARKER LOCATION. SHE STATED SHE WOULD FOLLOW-UP WITH THE PHYSICIAN. NO HARM OR INJURY TO THE PATIENT WAS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24032556 ↗MalfunctionDec 27, 2025Leak/Splash; Obstruction of Flow; Leak/Splash; Obstruction of Flow
MalfunctionDec 14, 2025Obstruction of Flow; Obstruction of Flow
MalfunctionNov 21, 2025Leak/Splash; Leak/Splash
MalfunctionNov 21, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING PLACEMENT OF A MEGA INTRA-AORTIC BALLOON (IAB) CATHETER VIA THE SUBCLAVIAN APPROACH, THE CATHETER BECAME KINKED. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23614460 ↗MalfunctionNov 17, 2025Leak/Splash; Air/Gas in Device; Leak/Splash; Air/Gas in Device
IT WAS REPORTED BY THE CUSTOMER TO THE EMERGENCY SUPPORT PROGRAM. NURSE CALLED TO REQUEST ASSISTANCE WITH A GAS LOSS ALARM. NURSE STATED THE PUMP HAD BEEN IN STANDBY FOR 10 MINUTES. (B)(6) 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. REVIEWED THE NATURE OF THIS ALARM AND DIFFERENT CLINICAL POSSIBILITIES. THE PATIENT WAS VENTILATED WITH A PEEP OF 5. DURING OUR DISCUSSION, THE PUMP ALARMED GAS GAIN. (B)(6) HAD PERFORMED PROPER TROUBLESHOOTING AGAIN. (B)(6) ALSO ENCOURAGED HER TO CHECK ALL THE CONNECTIONS ON THE HELIUM TUBING TO ENSURE THEY WERE CONNECTED. THE PUMP ALARMED GAS LOSS AGAIN, AND SHE RESOLVED THE ISSUE. (B)(6) HAD HER DECREASE THE AUGMENTATION LEVEL BY 2. (B)(6) EXPLAINED IF THE PUMP ALARMED GAS LOSS OR GAS GAIN AGAIN, THEN SHE WOULD NEED TO EXCHANGE THE PUMP. (B)(6) ENCOURAGED HER TO CALL ME DIRECTLY SHOULD IT OCCUR. (B)(6) COLLECTED PRODUCT SURVEILLANCE INFORMATION. (B)(6) DID NOT RECEIVE ANOTHER CALL BACK FROM (B)(6) ON MY SHIFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23566972 ↗MalfunctionNov 5, 2025Difficult to Insert; Difficult to Insert
MalfunctionNov 5, 2025Difficult to Insert; Difficult to Insert
MalfunctionNov 5, 2025Difficult to Insert; Difficult to Insert
MalfunctionNov 4, 2025Difficult to Insert; Difficult to Advance; Difficult to Insert; Difficult to Advance
IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON THERAPY, IAB HAD DIFFICULTY INSERTING THE BALLOON THRU THE 8 FRENCH SHEATH, BALLOON DIFFICULT TO ADVANCE THROUGH THE VALVE AND THE IABP CATHETER WILL START TO UNWRAP DURING THE PROCESS. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23464300 ↗MalfunctionOct 31, 2025Inappropriate Waveform; Inappropriate Waveform
IT WAS REPORTED THAT DURING USE OF BALLOON CATHETER INTRA-AORTIC BALLOON (IAB) THE INTRA-AORTIC BALLOON PUMP (IABP) DISPLAYED AN APPROPRIATE WAVEFORM, BUT THE PRESSURE READINGS WERE ABNORMALLY LOW AND INCONSISTENT WITH THE PATIENT¿S CLINICAL PRESENTATION AND NONINVASIVE BLOOD PRESSURE MEASUREMENTS. DESPITE NO SIGNS OF A DAMPED WAVEFORM, THE PRESSURES IMPROVED TEMPORARILY WITH SITE MANIPULATION, SUGGESTING POSSIBLE CATHETER POSITIONING ISSUES OR SIGNAL INTERFERENCE. AFTER TROUBLESHOOTING INCLUDING FLUSHING, ELECTRODE REPLACEMENT, AND RESTARTING THERAPY THE READINGS SLIGHTLY IMPROVED BUT REMAINED SIGNIFICANTLY LOWER THAN EXPECTED, PROMPTING PLANS FOR CATHETER REMOVAL. NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23434562 ↗MalfunctionOct 30, 2025Difficult to Advance; Difficult to Advance
InjuryOct 29, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING THE INTRA-AORTIC BALLOON THERAPY, THE MEGA 50CC BALLOON RUPTURED. THE REMOVAL OF THE R FEMORAL IABP REQUIRED A FEMORAL CUTDOWN BY VASCULAR SURGERY AND REPAIR OF ARTERIOTOMY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 23413963 ↗MalfunctionOct 28, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT DURING INTRA AORTIC BALLOON (IAB) THERAPY THE CUSTOMER HAD AN ISSUES WITH INSERTION OF THE BALLOON THRU THE SHEATH. THE CATHETER WAS DIFFICULT TO ADVANCE THROUGH THE VALVE AND THE IAB CATHETER WILL START TO UNWRAP DURING THE PROCESS. WENT TO AN 8.5 SHEATH TO INSERT A BALLOON.THERE WAS NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23400230 ↗MalfunctionOct 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
MalfunctionOct 17, 2025Component or Accessory Incompatibility; Activation, Positioning or Separation Problem; Component or Accessory Incompatibility; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT DURING USE, INTRA-AORTIC BALLOON (IAB) DILATOR DID NOT FIT TIGHTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23320954 ↗
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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