VAPR COOLPULSE 225032Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886705027965), received between Sep 27, 2022 and Aug 13, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (11 reports).

1 other recall cover devices cleared under the same FDA submission (K143475); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 7, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING A HIP SCOPE PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE VAPR COOLPULSE CURVE SUCTION ELECTRODE DEVICE CLOGGED-UP, AND THUS BLOCKING THE SUCTION AFTER AROUND 15 MINUTES OF USE. CHANGED TO ANOTHER ONE TO CONTINUE THE PROCEDURE BUT CLOGGED-UP THE FIRST TIME AFTER 10 MINUTES OF USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17472465 ↗
• MalfunctionAug 7, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING A HIP SCOPE PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE VAPR COOLPULSE CURVE SUCTION ELECTRODE DEVICE CLOGGED-UP, AND THUS BLOCKING THE SUCTION AFTER AROUND 15 MINUTES OF USE. CHANGED TO ANOTHER ONE TO CONTINUE THE PROCEDURE BUT CLOGGED-UP THE FIRST TIME AFTER 10 MINUTES OF USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17472460 ↗
• MalfunctionAug 7, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING A HIP SCOPE PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE VAPR COOLPULSE CURVE SUCTION ELECTRODE DEVICE CLOGGED-UP, AND THUS BLOCKING THE SUCTION AFTER AROUND 10 MINUTES OF USE. CHANGED TO ANOTHER ONE TO CONTINUE THE PROCEDURE BUT CLOGGED-UP THE FIRST TIME AFTER 5 TO 10 MINUTES OF USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17472452 ↗
• MalfunctionMay 31, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING A HIP ARTHROSCOPY PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT TWO VAPR COOLPULSE CURVE SUCTION ELECTRODE XL DEVICES MALFUNCTIONED. ACCORDING TO THE REPORT, THE FIRST ELECTRODE DEVICE CLOGGED AND THUS BLOCKED THE SUCTION AFTER AROUND 20 MINUTES WHILE THE SECOND ELECTRODE DEVICE CLOGGED THE FIRST TIME AFTER ONLY ONE MINUTE. IT WAS REPORTED THAT WITH REPEATED CLEANING, THE SECOND DEVICE WORKED UNTIL THE END OF THE OPERATION EVEN WITH THE SUCTION WAS NOT AS USUAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032554 ↗
• MalfunctionMay 31, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING A HIP ARTHROSCOPY PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT TWO VAPR COOLPULSE CURVE SUCTION ELECTRODE XL DEVICES MALFUNCTIONED. ACCORDING TO THE REPORT, THE FIRST ELECTRODE DEVICE CLOGGED AND THUS BLOCKED THE SUCTION AFTER AROUND 20 MINUTES WHILE THE SECOND ELECTRODE DEVICE CLOGGED THE FIRST TIME AFTER ONLY ONE MINUTE. IT WAS REPORTED THAT WITH REPEATED CLEANING, THE SECOND DEVICE WORKED UNTIL THE END OF THE OPERATION EVEN WITH THE SUCTION WAS NOT AS USUAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032550 ↗
• MalfunctionMay 9, 2023Infusion or Flow Problem; Output Problem; Infusion or Flow Problem; Output Problem

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE OF THE HIP ON (B)(6) 2023, TWO VAPR COOLPULSE CURVE SUCTION ELECTRODE XL DEVICES WERE USED. ACCORDING TO THE REPORT, THE FIRST ELECTRODE CLOGGED AND THUS BLOCKED THE SUCTION. IT WAS REPORTED THAT THEY WERE ABLE TO STILL CLEAN THE ELECTRODE A FEW TIMES SO THAT THE SUCTION WORKED AGAIN, BUT AT SOME POINT THIS DEVICE WAS NO LONGER OF ANY USE. IT WAS REPORTED THAT THE SECOND ELECTRODE CLOGGED THE FIRST TIME AFTER ONLY FIVE MINUTES OF USE. IT WAS REPORTED THAT WITH REPEATED CLEANING, THIS ONE WORKED UNTIL THE END OF THE OPERATION DESPITE THE SUCTION WAS NOT AS USUAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16897167 ↗
• MalfunctionMay 9, 2023Infusion or Flow Problem; Output Problem; Infusion or Flow Problem; Output Problem

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE OF THE HIP ON (B)(6) 2023, TWO VAPR COOLPULSE CURVE SUCTION ELECTRODE XL DEVICES WERE USED. ACCORDING TO THE REPORT, THE FIRST ELECTRODE CLOGGED AND THUS BLOCKED THE SUCTION. IT WAS REPORTED THAT THEY WERE ABLE TO STILL CLEAN THE ELECTRODE A FEW TIMES SO THAT THE SUCTION WORKED AGAIN, BUT AT SOME POINT THIS DEVICE WAS NO LONGER OF ANY USE. IT WAS REPORTED THAT THE SECOND ELECTRODE CLOGGED THE FIRST TIME AFTER ONLY FIVE MINUTES OF USE. IT WAS REPORTED THAT WITH REPEATED CLEANING, THIS ONE WORKED UNTIL THE END OF THE OPERATION DESPITE THE SUCTION WAS NOT AS USUAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16897166 ↗
• MalfunctionSep 27, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING A HIP ARTHROSCOPIC PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE VAPR COOLPULSE CURVE SUCTION ELECTRODE XL DEVICE WAS CLOGGED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15495330 ↗
• MalfunctionSep 27, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING A HIP ARTHROSCOPIC PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE VAPR COOLPULSE CURVE SUCTION ELECTRODE XL DEVICE WAS CLOGGED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15495254 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143475. One submission often covers many models, so check the product and lot details in each record.

• Z-0479-2016 · Nov 23, 2015 · Terminated
  VAPR TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)