VAPR COOLPULSE 228147Recalls & reported problems

Summary

The FDA's MAUDE database contains 305 adverse event reports that list this exact device (DI 10886705010097), received between Aug 28, 2014 and Sep 28, 2026 — classified as 13 injuries, 292 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (79 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 305 reports, in the reporter's own words as published by the FDA.

• 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 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 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 ↗
• MalfunctionJun 9, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE VAPR CLPLSE90 ELECTRODE W HAND CNTRLS DEVICE JAMMED AND COULD NOT SUCTION. 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 25447506 ↗
• MalfunctionJun 5, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE APR CLPLSE90 ELECTRODE W HAND CNTRLS DEVICE BECAME JAMMED. 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 25414582 ↗
• MalfunctionJun 4, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING SHOULDER SLEEVE REPAIR, THE VAPR COOLPULSE HAD SPARKS AND DID NOT RESPOND. 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 25390074 ↗
• MalfunctionJun 4, 2026Use of Device Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING SHOULDER CUFF REPAIR BLADE BLOCKAGE, THE VAPR COOLPULSE GOT JAMMED AND DID NOT WORK. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25390002 ↗
• MalfunctionJun 4, 2026Infusion or Flow Problem

  IT WAS REPORTED AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, IT WAS FOUND THAT THE VAPR COOLPULSE DID NOT SUCTION. 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 25389784 ↗
• MalfunctionJun 1, 2026Electrical /Electronic Property Problem; Material Fragmentation; Use of Device Problem

  IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE VAPR CLPLSE90 ELECTRODE W HAND CNTRLS DEVICE HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION AND WOULD NOT COAGULATE. IT WAS INITIALLY REPORTED THAT DURING AN ARTHROSCOPIC LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT THE DEVICE DID NOT WORK. THERE WERE NO DELAYS IN 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 25348136 ↗
• MalfunctionMay 28, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, WHEN USING THE VAPR CLPLSE90 ELECTRODE W HAND CNTRLS DEVICE, IT WAS OBSERVED THAT THE DEVICE BECAME JAMMED AND COULD NOT SUCTION. 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 25322979 ↗
• MalfunctionMay 27, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, THE VAPR COOLPULSE DEVICE COULD NOT SUCTION. THE ELECTRODE CONNECTED TO THE ASPIRATOR AND PUT IT INTO THE ARTICULAR CAVITY. IT WAS FOUND THAT THERE WAS NO SUCTION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF A 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 25305998 ↗
• MalfunctionMay 27, 2026Electrical /Electronic Property Problem; Output Problem

  IT WAS REPORTED THAT DURING A GLUTEAL MUSCLE CONTRACTURE SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VAPR CLPLSE90 ELECTRODE W HAND CNTRLS DEVICE SUDDENLY HAD NO ABILITY TO PERFORM ABLATION DURING SURGERY. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25305774 ↗
• MalfunctionMay 27, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, WHILE USING A 4.5 HEALIX ADVANCE BR W/OCORD ANCHOR DEVICE IT WAS OBSERVED THAT THE ANCHOR WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. IT WAS REPORTED THAT IN THE SAME PROCEDURE, WHILE USING A VAPR CLPLSE90 ELECTRODE W HAND CNTRLS DEVICE IT WAS OBSERVED THAT WHEN THE ELECTRODE WAS CONNECTED TO THE ASPIRATOR, AND PUT IT INTO THE ARTICULAR CAVITY, IT IS FOUND THAT THERE WAS NO SUCTION. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25304392 ↗
• MalfunctionMay 11, 2026Degraded; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT BEFORE THE MENISCAL REPAIR SURGERY WITH A VAPR CLPLSE90 ELECTRODE W HAND CNTRLS DEVICE, UPON OPENING THE DEVICE PACKAGE, IT WAS OBSERVED THAT THE DEVICE TIP HAD RUST. ADDITIONALLY, IT WAS REPORTED THAT "EMBROIDERY ECCHYMOSIS" AT THE TIP OF THE DEVICE. 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 25142754 ↗
• MalfunctionMay 11, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT DURING MENISCAL REPAIR SURGERY, THE VAPR COOLPULSE GOT JAMMED AND DID NOT WORK. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137732 ↗
• MalfunctionMay 4, 2026Device Remains Activated; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE THE VAPR CLPLSE90 ELECTRODE W HAND CNTRLS DEVICE BUTTON STUCK REMAINING IN ABLATION MODE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 5 MINUTE 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 25072418 ↗
• MalfunctionMay 4, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE VAPR CLPLSE90 ELECTRODE W HAND CNTRLS DEVICE WAS CLOGGED CAUSING SUCTION FAILURE. 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 25071925 ↗
• MalfunctionMar 31, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT A METAL COMPONENT OF THE VAPR CLPLSE90 ELECTRODE W HAND CNTRLS ELECTRODE DEVICE DETACHED AND FELL INTO THE PATIENT¿S KNEE. IT WAS NOT REPORTED IF THERE WERE ANY ADVERSE CONSEQUENCES TO THE PATIENT, OR IF THERE WAS A SURGICAL DELAY. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN MARCH OF 2026. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24742284 ↗
• MalfunctionMar 26, 2026Product Quality Problem; Detachment of Device or Device Component; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE VAPR CLPLSE90 ELECTRODE W HAND CNTRLS DEVICE FELL APART AND HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. IT WAS INITIALLY REPORTED THAT THE COOL PULSE 90 VAPR WAND WAS OPENED AND THE FACEPLATE WAS MISSING. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 24699156 ↗