Axius Blower/Mister CB-1000Recalls & reported problems
Maquet Cardiovascular LLC · Axius Blower/Mister · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
The Axius Blower/Mister CB-1000 sends carbon dioxide to keep the heart clear of blood during coronary bypass surgery. Most of the 43 reports describe gas flow problems — too much or too little flow, backflow, containers bursting, and parts breaking — with some hospitals saying saline bags "explode" when gas is directed into them and rollers that fail to close off tubing. One injury and no deaths are reported. There was 1 recall, closed, started January 2019, over possible loss of carbon dioxide flow that could delay the procedure.
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
- 43
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00607567700741), received between Nov 20, 2020 and Aug 24, 2026 — classified as 1 injury, 42 malfunctions.
The most frequently reported specific device problem is “Improper Flow or Infusion” (16 reports).
1 FDA recall record name this device's identifier.
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
- Jan 24, 2019Class IITerminated
Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).
Z-0983-2019 · Root cause: Employee error · Recall details · FDA record ↗
Most reported problems
Device problems
- Improper Flow or Infusion16
- Manufacturing, Packaging or Shipping Problem8
- Backflow6
- Burst Container or Vessel6
- Break3
- No Flow3
- Infusion or Flow Problem2
- Insufficient Device Problem Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- Insufficient Information9
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2026Backflow; Burst Container or Vessel; Insufficient Device Problem Information
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 50403869 ↗MalfunctionApr 22, 2026Backflow; Burst Container or Vessel
THE HOSPITAL REPORTED THAT THEY HAVE BEEN EXPERIENCING REGULAR PROBLEMS WITH THE BLOWER MISTER: THE BLOWER MISTER DIRECTS PART OF THE CO2 INTO THE BAG OF PHYSIOLOGICAL SALINE SOLUTION, SUCH THAT THE BAG ¿EXPLODES¿ AFTER SOME TIME.
Patient problems: Insufficient Information
MAUDE report 24950667 ↗MalfunctionApr 22, 2026Backflow; Burst Container or Vessel
THE HOSPITAL REPORTED THAT THEY HAVE BEEN EXPERIENCING REGULAR PROBLEMS WITH THE BLOWER MISTER: THE BLOWER MISTER DIRECTS PART OF THE CO2 INTO THE BAG OF PHYSIOLOGICAL SALINE SOLUTION, SUCH THAT THE BAG ¿EXPLODES¿ AFTER SOME TIME.
Patient problems: Insufficient Information
MAUDE report 24950666 ↗MalfunctionApr 22, 2026Backflow; Burst Container or Vessel
THE HOSPITAL REPORTED THAT THEY HAVE BEEN EXPERIENCING REGULAR PROBLEMS WITH THE BLOWER MISTER: THE BLOWER MISTER DIRECTS PART OF THE CO2 INTO THE BAG OF PHYSIOLOGICAL SALINE SOLUTION, SUCH THAT THE BAG ¿EXPLODES¿ AFTER SOME TIME.
Patient problems: Insufficient Information
MAUDE report 24950665 ↗MalfunctionApr 22, 2026Backflow; Burst Container or Vessel
THE HOSPITAL REPORTED THAT THEY HAVE BEEN EXPERIENCING REGULAR PROBLEMS WITH THE BLOWER MISTER: THE BLOWER MISTER DIRECTS PART OF THE CO2 INTO THE BAG OF PHYSIOLOGICAL SALINE SOLUTION, SUCH THAT THE BAG ¿EXPLODES¿ AFTER SOME TIME.
Patient problems: Insufficient Information
MAUDE report 24950664 ↗MalfunctionApr 7, 2026Backflow; Burst Container or Vessel; Insufficient Device Problem Information
THE HOSPITAL REPORTED THAT , THEY HAVE BEEN EXPERIENCING REGULAR PROBLEMS WITH BLOWER MISTER, 5-PACK: THE BLOWER MISTER DIRECTS PART OF THE CO2 INTO THE BAG OF PHYSIOLOGICAL SALINE SOLUTION, SUCH THAT THE BAG ¿EXPLODES¿ AFTER SOME TIME. THE SURGEON WAS FORCED TO INSTALL A NEW ONE DURING THE SAME OPERATION. THERE WAS NO DELAY. THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24796855 ↗MalfunctionMar 3, 2026Mechanical Problem
THE HOSPITAL REPORTED THAT THE ROLLER ON THE BLOWER MISTER DEVICE WAS NOT FUNCTIONING PROPERLY WHEN IT WAS ROLLED DOWN TO CLOSE OFF THE TUBING AND CONTROL THE FLOW. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED. NO DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24492980 ↗MalfunctionFeb 20, 2026No Flow
MalfunctionDec 1, 2025No Flow; No Flow
MalfunctionMar 3, 2025Improper Flow or Infusion; Improper Flow or Infusion
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING BLOWER MISTER (CB-1000), WHEN THE CO2 BLOWER WAS USED TO PERFORM VASCULAR ANASTOMOSIS, THE BLOOD SHOULD HAVE BEEN REMOVED TO SECURE A FIELD OF VISION, BUT THE BLOOD WAS NOT REMOVED AND THE CO2 WAS NOT DISCHARGED. IT WAS DETERMINED THAT THIS PRODUCT WAS DEFECTIVE AND A NEW PRODUCT WAS USED TO PERFORM THE SURGERY. THE NEWLY USED CO2 BLOWER PRODUCT HAD NO PROBLEMS WITH REMOVING BLOOD OR SECURING A FIELD OF VISION DURING VASCULAR ANASTOMOSIS, SO THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS A SLIGHT DELAY IN THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21510869 ↗MalfunctionFeb 10, 2025Improper Flow or Infusion; Improper Flow or Infusion
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING BLOWER MISTER, WHEN THE CO2 BLOWER WAS USED ON THE ANASTOMOSIS SITE TO REMOVE BLOOD AND SECURE A FIELD OF VISION, THE BLOOD WAS NOT REMOVED AND THE CO2 WAS NOT DISCHARGED. IT WAS DETERMINED THAT THIS PRODUCT WAS DEFECTIVE AND A NEW PRODUCT WAS USED TO PERFORM THE SURGERY. THE NEWLY USED CO2 BLOWER PRODUCT HAD NO PROBLEMS WITH REMOVING BLOOD OR SECURING A FIELD OF VISION DURING THE ANASTOMOSIS, SO THE SURGERY WAS COMPLETED SUCCESSFULLY. AFTER CONFIRMING THE DEFECT IN THE PRODUCT, A NEW PRODUCT WAS USED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PROCEDURE DELAYED BY ABOUT 20-30 MINUTES
Patient problems: Insufficient Information
MAUDE report 21351446 ↗MalfunctionNov 12, 2024Material Twisted/Bent; Material Twisted/Bent
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, BLOWER MISTER, 5-PACK ARE COMING BENT OUT OF THE SLEEVE. NEW DEVICE USED TO COMPLETE THE PROCEDURE. NO DELAY. NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20662613 ↗MalfunctionNov 11, 2024Material Twisted/Bent; Material Twisted/Bent
N/A.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20658211 ↗InjuryOct 4, 2024Improper Flow or Infusion; Improper Flow or Infusion
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, BLOWER MISTER, 5-PACK (CO2 + FLUSHING SYSTEM) DURING BYPASS SURGERY, THE INFUSION BAG IN THE PRESSURE BAG "EXPLODED". WATER SPREAD THROUGHOUT THE OPERATING ROOM, OVER THE SURGICAL AREA AND PRESUMABLY ALSO INTO THE OPEN THORAX. IT IS NOT CLEAR WHETHER TOO MUCH PRESSURE ON THE PRESSURE BAG AND/OR A DEFECT IN THE INFUSION BAG WERE THE CAUSE. NO SERIOUS CONSEQUENCES. ALL NECESSARY AND POSSIBLE ANTISEPSIS MEASURES WERE TAKEN INTRAOPERATIVELY (ADMINISTRATION OF ANTIBIOTICS THROUGH ANESTHESIA, REPLACEMENT OF MATERIALS, SURGICAL GOWNS AND GLOVES). CLEANING OF WET SURFACES. THERE WAS A DELAY.
Patient problems: Insufficient Information
MAUDE report 20374193 ↗MalfunctionOct 3, 2024Break; Break
THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, BLOWER MISTER SPIKE BROKE OFF WHEN HARVESTER WENT TO SPIKE THE IV BAG. A NEW DEVICE WAS USED TO PERFORM THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO DELAY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20358813 ↗MalfunctionSep 11, 2024Improper Flow or Infusion; Improper Flow or Infusion
MalfunctionSep 26, 2023Improper Flow or Infusion; Improper Flow or Infusion
MalfunctionAug 11, 2023Improper Flow or Infusion; Improper Flow or Infusion
MalfunctionAug 11, 2023Improper Flow or Infusion; Improper Flow or Infusion
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, BLOWER MISTER WORKED FINE WHILE WORKING ON THE FIRST GRAFT. THEY USED TO ROLLER BALL TO CLAMP OFF CO2 AND SET THE DEVICE DOWN WHILE PREPARING THE SECOND GRAFT. WHEN THEY PICKED UP THE BLOWER MISTER TO USE ON THE SECOND GRAFT, THEY LOOSENED THE ROLLER BALL BUT THE CO2 DIDN'T COME OUT AS IT SHOULD. THE FLOW OF CO2 SEEMED RESTRICTED. THEY TRIED SEVERAL TROUBLE SHOOTING IDEAS TO ADDRESS ISSUE BY ADJUSTING BAG PRESSURE AND CO2 WALL PRESSURE BUT NOTHING WORKED. THE CASES WAS RESUMED AND FINISH BY OPENING A NEW BLOWER MISTER AND USED WITHOUT ISSUE. NO PROCEDURAL DELAY BEYOND OPENING A NEW DEVICE IN EACH CASE. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17510065 ↗MalfunctionJul 31, 2023Improper Flow or Infusion; Improper Flow or Infusion
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THEY SET UP AXIUS BLOWER MISTER C-CB-1000 AND COULDN'T REGULATE THE FLOW WITH THE THUMB WHEEL. IT ALWAYS STAYED AT FULL FLOW. THEY REPLACED THE FULL SYSTEM WITH A NEW ONE. IT WASN'T USED ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17431146 ↗MalfunctionJul 14, 2023Moisture Damage; Moisture Damage
THE HOSPITAL REPORTED THAT WHEN THEY WERE GATHERING THE BLOWER MISTER, 5-PACK FOR A CORONARY ARTERY BYPASS CASE, IT WAS DISCOVERED THAT IT HAD LIQUID WATER INSIDE STERILE PACKAGING. THE BLOW MISTER WAS STORED ON THE SHELF IN THE CLEAN CORE OF THE OR. THE PACKAGING WAS NOT VISIBLY DAMAGED OR COMPROMISED. ANOTHER PACK WAS USED, NO CONDENSATION ON THE OTHER ITEM. THE PRODUCT WAS NOT USED ON THE PATIENT/ NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17325185 ↗MalfunctionFeb 20, 2023Improper Flow or Infusion; Improper Flow or Infusion
MalfunctionNov 30, 2022Break; Break
MalfunctionNov 30, 2022Break; Break
THE HOSPITAL REPORTED THAT BEFORE THE PROCEDURE, A BLOWER MISTER USED FOR A CORONARY ARTERY BYPASS CONNECTOR FALLS OFF. REPLACEMENT WITH A NEW DEVICE WAS USED TO COMPLETE SURGERY. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15887593 ↗MalfunctionSep 30, 2022Infusion or Flow Problem; Infusion or Flow Problem
RELATED TO TW 685695. THE HOSPITAL REPORTED THAT THE BLOWER MISTER USED FOR THE CORONARY ARTERY BYPASS PROCEDURE HAD CREASES IN THE FLOW OF THE CATHETER, AND THE LIQUID CANNOT PASS SMOOTHLY. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15509750 ↗
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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 · 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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