InnoWave ProRecalls & reported problems
Medisafe Uk Limited · The InnoWave Pro 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00724995152741), received between Sep 19, 2022 and Oct 21, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Fell” (1 report).
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
Device problems
- Device Fell1
- No Apparent Adverse Event1
Patient problems
- Laceration(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2022Device Fell; Device Fell
THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A CUT ON THEIR HAND WHEN ATTEMPTING TO CATCH A FALLING BASKET AS IT WAS BEING REMOVED FROM THEIR INNOWAVE PRO SONIC IRRIGATOR. THE EMPLOYEE RECEIVED STITCHES DUE TO THE REPORTED EVENT.
Patient problems: Laceration(s)
MAUDE report 15651389 ↗MalfunctionSep 19, 2022No Apparent Adverse Event; No Apparent Adverse Event
THE USER FACILITY REPORTED VIA MEDWATCH (B)(4) 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 15446925 ↗
Other Disinfector, medical devices devices
- GETINGE 88-SERIES 88-5Getinge Disinfection AB · Disinfector, Medical Devices3 recalls6 reports
- GETINGE 88-SERIES 88-5Getinge Disinfection AB · Disinfector, Medical Devices3 recalls0 reports
- GETINGE CM320-SERIESGetinge Disinfection AB · Disinfector, Medical Devices2 recalls3 reports
- GETINGE CM320-SERIESGetinge Disinfection AB · Disinfector, Medical Devices2 recalls1 report
- GETINGE 86-SERIES S-8668Getinge Disinfection AB · Disinfector, Medical Devices1 recall37 reports
- Getinge Aquadis 56 56MGetinge Disinfection AB · Disinfector, Medical Devices1 recall11 reports
- AMSCO 7052HPCorporation Steris Canada · Disinfector, medical devices1 recall10 reports
- GETINGE 9100-SERIES 9128EGetinge Disinfection AB · Disinfector, Medical Devices1 recall10 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.