SIMPULSE 0067010Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741065293), received between Oct 15, 2019 and May 6, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2020Corroded; Corroded

  IT WAS REPORTED THAT THERE WAS CORROSION NOTED ON THE BATTERY COMPARTMENT OF THE SIMPULSE VARICARE DEVICE. THE CORROSION WAS OBSERVED WHEN THEY WENT TO USE THE IRRIGATOR AND IT WOULD NOT WORK PROPERLY. THERE WAS NO CONTACT OF THE DEVICE WITH THE PATIENT OR THE STERILE FIELD. THE DEVICE WAS BEING USED FOR CLOSED PULSE IRRIGATION, AND IT WAS UNABLE TO COMPLETE ANY PROCEDURES BECAUSE IT DID NOT WORK ON INITIAL ATTEMPT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10029906 ↗
• MalfunctionMay 5, 2020Corroded; Corroded

  IT WAS REPORTED THAT THERE WAS CORROSION NOTED ON THE BATTERY COMPARTMENT OF THE SIMPULSE VARICARE DEVICE. THE CORROSION WAS OBSERVED WHEN THEY WENT TO USE THE IRRIGATOR AND IT WOULD NOT WORK PROPERLY. THERE WAS NO CONTACT OF THE DEVICE WITH THE PATIENT OR THE STERILE FIELD. THE DEVICE WAS BEING USED FOR CLOSED PULSE IRRIGATION, AND IT WAS UNABLE TO COMPLETE ANY PROCEDURES BECAUSE IT DID NOT WORK ON INITIAL ATTEMPT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10026030 ↗
• MalfunctionNov 22, 2019Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED PER THE USER FACILITY THAT DURING USE OF THE SIMPULSE VARICARE, THE DEVICE WAS LEAKING FLUID AT THE CONNECTION POINT OF WHERE THE TIP ATTACHES TO THE HANDLE. IT WAS REPORTED THAT THERE WAS NO DAMAGE TO THE DEVICE. IT WAS REPORTED THAT THE DEVICE WAS ONLY USED WITH ONE PATIENT AND THE BATTERIES WERE CHANGED DURING THE TIME OF USE, TOWARDS THE END OF TREATMENT. THERE WAS NO PATIENT INJURY REPORTED. THE SUBJECT PRODUCT WAS RETURNED AND DURING VISUAL INSPECTION IT WAS NOTED THE BATTERY CASE LATCH TAB WAS BROKEN AND NOT RETURNED WITH THE PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9363952 ↗
• MalfunctionOct 15, 2019Break; Break

  IT WAS REPORTED PER THE USER FACILITY THAT DURING USE OF THE SIMPULSE VARICARE IRRIGATOR, THE DEVICE WOULD NOT IRRIGATE. THERE WAS NO PATIENT INJURY REPORTED. THE SUBJECT PRODUCT WAS RETURNED AND DURING VISUAL INSPECTION IT WAS NOTED THAT THE BATTERY CASE LATCH TAB WAS BROKEN AND NOT RETURNED WITH THE PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9194259 ↗
• MalfunctionOct 15, 2019Break; Crack; Break; Crack

  IT WAS REPORTED PER THE USER FACILITY THAT DURING USE OF THE SIMPULSE VARICARE IRRIGATOR, THE DEVICE WOULD NOT IRRIGATE. THERE WAS NO PATIENT INJURY REPORTED. THE SUBJECT PRODUCT WAS RETURNED AND DURING VISUAL INSPECTION IT WAS NOTED THAT THE BATTERY CASE LATCH TAB WAS BROKEN AND NOT RETURNED WITH THE PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9194253 ↗
• MalfunctionOct 15, 2019Break; Break

  IT WAS REPORTED PER THE USER FACILITY THAT DURING USE OF THE SIMPULSE VARICARE IRRIGATOR, THE DEVICE WOULD NOT IRRIGATE. THERE WAS NO PATIENT INJURY REPORTED. THE SUBJECT PRODUCT WAS RETURNED AND DURING VISUAL INSPECTION IT WAS NOTED THAT THE BATTERY CASE LATCH TAB WAS BROKEN AND NOT RETURNED WITH THE PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9194246 ↗
• MalfunctionOct 15, 2019Break; Break

  IT WAS REPORTED PER THE USER FACILITY THAT DURING USE OF THE SIMPULSE VARICARE IRRIGATOR, THE DEVICE WOULD NOT IRRIGATE. THERE WAS NO PATIENT INJURY REPORTED. THE SUBJECT PRODUCT WAS RETURNED AND DURING VISUAL INSPECTION IT WAS NOTED THAT THE BATTERY CASE LATCH TAB WAS BROKEN AND NOT RETURNED WITH THE PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9194245 ↗