VAPR COOLPULSERecalls & reported problems across all models
Medos International Sàrl · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 2 models of VAPR COOLPULSE by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 41 adverse event reports in the FDA's MAUDE database, received between Oct 17, 2019 and Aug 13, 2026 — classified as 1 injury, 40 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (18 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported VAPR COOLPULSE problems
Device problems
- Infusion or Flow Problem18
- Electrical /Electronic Property Problem8
- Output Problem8
- Blocked Connection5
- Device Remains Activated3
- Physical Resistance/Sticking2
- Power Problem2
- Circuit Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- No Consequences Or Impact To Patient2
- Foreign Body In Patient1
VAPR COOLPULSE models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VAPR COOLPULSE 225031Electrosurgical, cutting & coagulation & accessories27 reports
- VAPR COOLPULSE 225032Electrosurgical, cutting & coagulation & accessories14 reports
Recent VAPR COOLPULSE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Electrical /Electronic Property Problem; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50241132 ↗MalfunctionFeb 10, 2026Electrical /Electronic Property Problem
THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, TWO COOLPULSE CURVE DEVICES WERE NOT COAGULATING FAST ENOUGH WITH THE ELECTRODES FOR THE PAST MONTH. ACCORDING TO THE REPORTER, THE CONSOLE WAS EXCHANGED AND DIFFERENT BATCH NUMBERS WERE TRIED WITHOUT SUCCESS, AND THERE WERE NO ISSUES WITH THE CONSOLE'S SCREEN TRACKING. IT WAS REPORTED THAT FUNCTIONING WAS OKAY WITH THE HOOKS. THE PROCEDURE WAS DELAYED, THOUGH THE EXACT DURATION OF THE DELAY WAS NOT SPECIFIED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN JANUARY 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24307843 ↗MalfunctionFeb 10, 2026Electrical /Electronic Property Problem
THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, TWO COOLPULSE CURVE DEVICES WERE NOT COAGULATING FAST ENOUGH WITH THE ELECTRODES FOR THE PAST MONTH. ACCORDING TO THE REPORTER, THE CONSOLE WAS EXCHANGED AND DIFFERENT BATCH NUMBERS WERE TRIED WITHOUT SUCCESS, AND THERE WERE NO ISSUES WITH THE CONSOLE'S SCREEN TRACKING. IT WAS REPORTED THAT FUNCTIONING WAS OKAY WITH THE HOOKS. THE PROCEDURE WAS DELAYED, THOUGH THE EXACT DURATION OF THE DELAY WAS NOT SPECIFIED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN JANUARY 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24307835 ↗MalfunctionFeb 10, 2026Electrical /Electronic Property Problem; Power Problem
THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING 2X COOLPULSE CURVE DEVICES, COAGULATION WAS NOT FAST ENOUGH WITH ELECTRODES FOR ONE MONTH. THE OPERATION WAS OKAY WITH HOOKS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS AN UNSPECIFIED DELAY TO THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24307530 ↗MalfunctionFeb 10, 2026Electrical /Electronic Property Problem; Power Problem
THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING 2X COOLPULSE CURVE DEVICES, COAGULATION WAS NOT FAST ENOUGH WITH ELECTRODES FOR ONE MONTH. THE OPERATION WAS OKAY WITH HOOKS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS AN UNSPECIFIED DELAY TO THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24307360 ↗MalfunctionNov 18, 2025Blocked Connection; Blocked Connection
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE TWO (X2) COOLPULSE CURVE XL DEVICES WERE BEING USED WHEN IT DIDN'T GO AS PLANNED AND HAD TO OPEN MULTIPLE VAPER WANDS. THEY WERE OPENED TO USE AND THE GENERATOR WAS NOT READING THE WANDS. WE LATER FOUND OUT THAT IT DID NOT HAVE THE UPGRADED SOFTWARE NEEDED FOR THOSE WANDS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. THIS IS 2 OF 2 FOR THE SAME EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23585484 ↗MalfunctionNov 18, 2025Blocked Connection; Blocked Connection
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE TWO (X2) COOLPULSE CURVE XL DEVICES WERE BEING USED WHEN IT DIDN'T GO AS PLANNED AND HAD TO OPEN MULTIPLE VAPER WANDS. THEY WERE OPENED TO USE AND THE GENERATOR WAS NOT READING THE WANDS. WE LATER FOUND OUT THAT IT DID NOT HAVE THE UPGRADED SOFTWARE NEEDED FOR THOSE WANDS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. THIS IS 1 OF 2 FOR THE SAME EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23584646 ↗MalfunctionSep 11, 2025Misconnection; Blocked Connection; Output Problem; Misconnection; Blocked Connection; Output Problem
IT WAS REPORTED THAT DURING A HIP LABRUM REPAIR ON HIP JOINT PROCEDURE, AN ATTEMPT WAS MADE TO CONNECT A COOLPULSE CURVE DEVICE TO THE VAPR VUE GENERATOR DEVICE AND USE WAS ATTEMPTED, BUT THE MESSAGE "INVALID" WAS DISPLAYED AND THE COOLPULSE CURVE WAS NOT CONNECTED. IT WAS REPORTED THAT THE POWER WAS SWITCHED OFF AND ON, THE COOLPULSE CURVE WAS LOADED AND BECAME USABLE FOR AWHILE, BUT AFTER JUST A FEW SECONDS OF OPERATING THE FOOT SWITCH, THE DISPLAY IMMEDIATELY CHANGED TO "INVALID" AND THE CONNECTION BECAME IMPOSSIBLE. FURTHER ATTEMPTS WERE MADE TO POWER THE DEVICE OFF AND ON, BUT THE COOLPULSE CURVE STILL DID NOT CONNECT PROPERLY. AS THE SURGERY COULD NOT BE CONTINUED, A DIFFERENT TYPE OF HANDPIECE PROBE WAS TRIED AND WAS ABLE TO CONNECT WITHOUT ANY PROBLEMS. THE SURGERY CONTINUED USING THIS AND WAS COMPLETED WITHOUT FURTHER PROBLEMS. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23025392 ↗MalfunctionSep 9, 2025Device Remains Activated; Mechanical Jam; Device Remains Activated; Mechanical Jam
IT WAS REPORTED THAT DURING A HIGH TIBIAL OSTEOTOMY (HTO) AND MEDIAL MENISCUS POSTERIOR ROOT TEAR (MMPRT) ON KNEE FOR OSTEOARTHRITIS (OA) AND MENISCUS POSTERIOR ROOT TEAR, WHILE USING THE COOLPULSE CURVE DEVICE, THE HEMOSTATIC MODE SUDDENLY TURNED ON EVEN THOUGH THE FOOT SWITCH OR HAND CONTROL WAS NOT PRESSED. THE CORD WAS UNPLUGGED, THE UNIT WAS TURNED BACK ON, AND WHEN IT WAS PLUGGED BACK IN, THE DISPLAY SHOWED SOMETHING LIKE "¿ STUCK ." SEVERAL ATTEMPTS WERE MADE TO UNPLUG AND PLUG THE CORD BACK IN, HOWEVER THIS DID NOT IMPROVE THE SITUATION. A NEW DEVICE WAS OPENED AND TESTED, WHICH WORKED WITHOUT ANY PROBLEM. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23004973 ↗MalfunctionJul 25, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE COOLPULSE CURVE DEVICE SUCTION DID NOT WORK IMMEDIATELY AFTER THE USER STARTED TO USE THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22612390 ↗MalfunctionMay 29, 2025Infusion or Flow Problem; Output Problem; Infusion or Flow Problem; Output Problem
IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT FIVE MINUTES AFTER STARTING TO USE THE COOLPULSE CURVE DEVICE, THE SUCTION STOPPED WORKING AND IT COULD NOT BE USED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22104736 ↗MalfunctionMay 21, 2025Output Problem; Output Problem
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS FOUND THAT THE ALARM ON THE COOLPULSE CURVE DEVICE WAS FREQUENTLY SOUNDING AND THEN IT STOPPED OUTPUTTING ENTIRELY. AFTER SWITCHING TO A DIFFERENT PROBE, THE DEVICE OPERATED WITHOUT ANY ISSUES, SUGGESTING THAT THE PROBLEM LIES WITH THE ORIGINAL PROBE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061347 ↗MalfunctionSep 11, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED FROM JAPAN THAT PREOPERATIVELY TO AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TIP ON THE COOLPULSE CURVE DEVICE WAS WAS CLEARLY DIRTY UPON OPENING. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20191209 ↗MalfunctionJul 12, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED, BY THE SALES REP IN (B)(6). THAT DURING, A HIP SURGICAL PROCEDURE ON (B)(6) 2024. THE 2X COOLPULSE CURVE XL DEVICE FREQUENTLY BECOMES CLOGGED. THE VAPOR WAS CONNECTED TO THE NEPTUNE WITH SUCTION AND DIFFERENT SUCTION POWERS WERE TESTED. WE ALSO, TRY TO CONNECT IT WITH THE OUTFLOW PUMP CANNULA, BUT THE PROBLEM WAS STILL. ADDITIONALLY, AFTER THE CLOGGING, AN ATTEMPT WAS MADE TO ENLARGE THE CONNECTION AT THE WHITE END. THE DISTAL HOLES ARE NOT CLOGGED. THIS ISSUE OCCURS MAINLY IN THE AREA OF THE CAPSULE OPENING AND THE LABRUM. PREVENTING THE SURGEON FROM OPERATING PROPERLY AS THE WATER TURNS BROWN AND CAUSES AN EXTREME NUMBER OF AIR BUBBLES. IT WAS UNKNOWN, IF THERE WAS A DELAY IN THE PROCEDURE REPORTED OR IF THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 OF THE SAME EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19729532 ↗MalfunctionJul 12, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED, BY THE SALES REP IN SWITZERLAND. THAT DURING, A HIP SURGICAL PROCEDURE ON (B)(6) 2024. THE 2X COOLPULSE CURVE XL DEVICE FREQUENTLY BECOMES CLOGGED. THE VAPOR WAS CONNECTED TO THE NEPTUNE WITH SUCTION, AND DIFFERENT SUCTION POWERS WERE TESTED. WE ALSO, TRY TO CONNECT IT WITH THE OUTFLOW PUMP CANNULA, BUT THE PROBLEM WAS STILL. ADDITIONALLY, AFTER THE CLOGGING, AN ATTEMPT WAS MADE TO ENLARGE THE CONNECTION AT THE WHITE END. THE DISTAL HOLES ARE NOT CLOGGED. THIS ISSUE OCCURS MAINLY IN THE AREA OF THE CAPSULE OPENING AND THE LABRUM. PREVENTING THE SURGEON FROM OPERATING PROPERLY AS THE WATER TURNS BROWN AND CAUSES AN EXTREME NUMBER OF AIR BUBBLES. IT WAS UNKNOWN, IF THERE WAS A DELAY IN THE PROCEDURE REPORTED OR IF THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 OF THE SAME EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19729519 ↗
Other Medos International Sàrl products
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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