InnoWave PCFRecalls & reported problems
Medisafe Uk Limited · The InnoWave PCF Sonic Irrigator is a High-Pressure, Ultrasonic, Flushing Washer Disinfector for the medical market. It is intended to provide ultrasonic cleaning and low-level thermal disinfection of surgical instruments, including complex lumen-cannulated devices, such as robotic surgical instruments. · Class 2
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00724995152710), received between Apr 1, 2022 and Mar 12, 2026 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Smoking” (5 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.
Reports received per month
Most reported problems
Device problems
- Smoking5
- Mechanical Problem4
- Device Fell3
- Leak/Splash3
- Fire2
- No Apparent Adverse Event2
- Detachment of Device or Device Component1
- Melted1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Pain5
- Bruise/Contusion1
- Insufficient Information1
- Swelling/ Edema1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2026Smoking
THE USER FACILITY REPORTED THAT SMOKE WAS EMITTING FROM THEIR INNOWAVE PCF SONIC IRRIGATOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578534 ↗MalfunctionDec 5, 2025Mechanical Problem; Mechanical Problem
THE USER FACILITY REPORTED THAT THE GAS STRUT SUPPORTING THE LID TO THEIR INNOWAVE PCF SONIC IRRIGATOR DETACHED RESULTING IN AN ARM INJURY TO AN EMPLOYEE. THE EMPLOYEE SOUGHT AND RECEIVED MEDICAL TREATMENT.
Patient problems: Pain
MAUDE report 23728320 ↗MalfunctionNov 21, 2025Device Fell; Device Fell
THE USER FACILITY REPORTED THE LID TO THEIR INNOWAVE PCF SONIC IRRIGATOR FELL ON AN EMPLOYEE'S HAND WHILE LOADING A TRAY INTO THE UNIT. MEDICAL TREATMENT WAS SOUGHT, HOWEVER IT IS UNKNOWN IF ANY MEDICAL TREATMENT WAS ADMINISTERED.
Patient problems: Swelling/ Edema
MAUDE report 23617404 ↗MalfunctionNov 19, 2025Mechanical Problem; Mechanical Problem
THE USER FACILITY REPORTED THAT THE GAS STRUT SUPPORTING THE LID TO THEIR INNOWAVE PCF SONIC IRRIGATOR DETACHED RESULTING IN A SHOULDER INJURY TO AN EMPLOYEE. THE EMPLOYEE SOUGHT MEDICAL TREATMENT HOWEVER, IT WAS NOT DISCLOSED THE TYPE OF TREATMENT RECEIVED.
Patient problems: Pain
MAUDE report 23595885 ↗MalfunctionNov 7, 2025Smoking; Smoking
THE USER FACILITY REPORTED THAT THEIR INNOWAVE PCF SONIC IRRIGATOR WAS EMITTING SMOKE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23498870 ↗MalfunctionOct 27, 2025Fire; Fire
THE USER FACILITY REPORTED THAT WIRING WITHIN THEIR INNOWAVE PCF SONIC IRRIGATOR CAUGHT FIRE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23392803 ↗MalfunctionOct 24, 2025Melted; Melted
THE USER FACILITY REPORTED THAT A CONNECTOR IN THEIR INNOWAVE PCF SONIC IRRIGATOR WAS "PARTIALLY" MELTED. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23381390 ↗MalfunctionOct 24, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBSERVED WATER TO BE LEAKING FROM THE LID OF THEIR INNOWAVE ULTRASONIC PCF IRRIGATOR. THE EMPLOYEE APPROACHED THE UNIT, PROCEEDED TO OPEN THE LID, SUBSEQUENTLY CAUSING HOT WATER TO CONTACT HER. IT IS UNKNOWN AT THIS TIME WHETHER MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23381389 ↗MalfunctionSep 5, 2025Mechanical Problem; Smoking; Mechanical Problem; Smoking
THE USER FACILITY REPORTED THAT SMOKE EMITTED FROM THEIR INNOWAVE ULTRASONIC PCF IRRIGATOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22976809 ↗MalfunctionSep 5, 2025Fire; Fire
THE USER FACILITY REPORTED THAT THE SK5 PLUG TO THEIR INNOWAVE ULTRASONIC PCF IRRIGATOR CAUGHT FIRE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22976300 ↗MalfunctionJun 27, 2025Leak/Splash; Leak/Splash
A STERIS SERVICE TECHNICIAN WAS PERFORMING SERVICE ACTIVITY ON EQUIPMENT IN THE ROOM IN WHICH THE USER FACILITY'S INNOWAVE PCF SONIC IRRIGATOR IS LOCATED. THE TECHNICIAN OBSERVED THAT THE UNIT'S LID WAS OPEN, AND THE UNIT WAS SPRAYING WATER ONTO THE FLOOR. THE TECHNICIAN IMMEDIATELY CLOSED THE LID AND SHUT DOWN THE UNIT. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22344958 ↗MalfunctionMar 26, 2025Smoking; Smoking
THE USER FACILITY REPORTED THAT SMOKE WAS EMITTING FROM THEIR INNOWAVE PCF SONIC IRRIGATOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21697670 ↗MalfunctionDec 13, 2024Smoking; Smoking
THE USER FACILITY REPORTED THAT THEIR INNOWAVE PCF SONIC IRRIGATOR UNIT WAS SMOKING DURING OPERATION. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20925062 ↗MalfunctionOct 23, 2024Mechanical Problem; Mechanical Problem
THE USER FACILITY REPORTED THAT THE LID OF THEIR INNOWAVE PCF SONIC IRRIGATOR CLOSED ON AN EMPLOYEE'S ARM RESULTING IN SORENESS.
Patient problems: Pain
MAUDE report 20515864 ↗MalfunctionSep 27, 2024Unintended Movement; Unintended Movement
THE USER FACILITY REPORTED THAT THE LID OF THEIR INNOWAVE PCF SONIC IRRIGATOR CLOSED ON AN EMPLOYEE'S HAND RESULTING IN AN INJURY. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Pain
MAUDE report 20321334 ↗MalfunctionNov 8, 2023Device Fell; Device Fell
THE USER FACILITY REPORTED THAT THE LID OF THEIR INNOWAVE PCF SONIC IRRIGATOR CLOSED ON AN EMPLOYEE'S ARM RESULTING IN AN INJURY. MEDICAL TREATMENT WAS SOUGHT AND ADMINISTERED.
Patient problems: Pain
MAUDE report 18093149 ↗MalfunctionApr 12, 2023No Apparent Adverse Event; No Apparent Adverse Event
THE USER FACILITY REPORTED VIA MEDWATCH REPORT (MW5115425) THAT PREVENTIVE MAINTENANCE (PM) ON THEIR INNOWAVE PCF SONIC IRRIGATOR WAS UNABLE TO BE COMPLETED DUE TO PM PARTS BEING ON BACKORDER. THE USER FACILITY EXPRESSED SAFETY AND REGULATORY CONCERN DUE TO MISSED MAINTENANCE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16725206 ↗MalfunctionNov 10, 2022Device Fell; Device Fell
THE USER FACILITY REPORTED THAT THE LID OF THEIR INNOWAVE PCF SONIC IRRIGATOR CLOSED ON AN EMPLOYEE'S HAND RESULTING IN AN INJURY TO THEIR FINGER; THE EMPLOYEE RETURNED TO WORK. NO REPORT OF MEDICAL TREATMENT SOUGHT OR ADMINISTERED.
Patient problems: Insufficient Information
MAUDE report 15775188 ↗MalfunctionAug 11, 2022Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR INNOWAVE PCF SONIC IRRIGATOR ONTO THE FLOOR. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15212002 ↗MalfunctionAug 10, 2022No Apparent Adverse Event; No Apparent Adverse Event
THE USER FACILITY REPORTED VIA MEDWATCH (MW5110691) THAT PREVENTIVE MAINTENANCE (PM) WAS UNABLE TO BE COMPLETED ON THEIR ULTRASONIC CLEANER DUE TO BACK ORDERED PM PARTS. THE USER FACILITY EXPRESSED SAFETY AND REGULATORY CONCERN DUE TO MISSED MAINTENANCE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15204052 ↗MalfunctionApr 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT AN EMPLOYEE WAS OPERATING THEIR INNOWAVE PCF SONIC IRRIGATOR WHEN THE LID FELL AND CONTACTED THE EMPLOYEE'S FOREARM. MEDICAL TREATMENT WAS ADMINISTERED (ICE).
Patient problems: Bruise/Contusion
MAUDE report 13979721 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.