VAPR COOLPULSERecalls & reported problems across all models

We found 2 models of VAPR COOLPULSE by Depuy Mitek, LLC in the FDA's device registry (GUDID). Together they are named in 779 adverse event reports in the FDA's MAUDE database, received between Aug 28, 2014 and Sep 30, 2026 — classified as 25 injuries, 754 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (263 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

Most reported VAPR COOLPULSE problems

VAPR COOLPULSE models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VAPR COOLPULSE 228146

  ARTHROSCOPE
  474 reports
• VAPR COOLPULSE 228147

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  305 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.

• MalfunctionSep 30, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950035 ↗
• MalfunctionSep 28, 2026Electrical /Electronic Property Problem

  It was reported that during a meniscal repair surgical procedure it was observed that the VAPR CLPLSE90 ELECTRODE W HAND CNTRLS device was generating sparks from the blade tip. It is unknown if there any signs of overheating, burning, smoke, fire, unusual odor, or visible device damage. It was reported that the device was being used according to its intended use and current labeling at the time of the event. It was reported that another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information could be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912564 ↗
• MalfunctionSep 23, 2026Device Contaminated During Manufacture or Shipping

  It was reported that during an unspecified arthroscopic procedure the VAPR CLPLSE90 ELECTRODE W HAND CNTRLS device noted before surgery the device tip had rust and not use. Another device was used to complete the procedure. There was no delay in the procedure reported. There were no adverse patient consequences reported. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871837 ↗
• MalfunctionSep 14, 2026Detachment of Device or Device Component

  It was reported that during an unknown procedure, it was discovered that the metal piece on the VAPR COOLPULSE90 ELECTRODE device fell off. It was not reported if there were any delays to the surgical procedure. It was reported that a spare device was used to complete the surgery. 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 50757421 ↗
• MalfunctionSep 3, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50596141 ↗
• MalfunctionSep 2, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571440 ↗
• MalfunctionSep 1, 2026Display or Visual Feedback Problem; Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50548809 ↗
• MalfunctionAug 25, 2026Device Damaged Prior to Receipt by User

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50438725 ↗
• MalfunctionAug 25, 2026Device Damaged Prior to Receipt by User

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50438724 ↗
• MalfunctionAug 25, 2026Overheating of Device

  It was reported that during an unspecified surgery, it was noted that the tip of the VAPR COOLPULSE was charred. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50427187 ↗
• MalfunctionAug 20, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50351257 ↗
• MalfunctionAug 12, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50228691 ↗
• MalfunctionAug 11, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201856 ↗
• MalfunctionAug 5, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50139283 ↗
• MalfunctionAug 5, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50139281 ↗

Other Depuy Mitek, LLC products

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• QUICKANCHOR ETHIBOND TAPERCUT2 models · 104 reports
• INTRAFIX14 models · 91 reports
• MILAGRO10 models · 88 reports