SIMPULSE 0067600Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741010149), received between Nov 14, 2018 and Nov 15, 2018 — classified as 2 malfunctions.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2018Unsealed Device Packaging; Device Damaged Prior to Receipt by User; Unsealed Device Packaging; Device Damaged Prior to Receipt by User

  A SIMPULSE SOLO IRRIGATOR REPORTED AS NOT PRIMING AND HAVING A SLOW/SLUGGISH STREAM WAS RETURNED TO DAVOL FOR EVALUATION. THE PRODUCT WAS RETURNED UNUSED. THE PACKAGE WAS FOUND WITH A BREACH IN THE STERILE BARRIER. ON THE LID WAS WRITTEN BY THE CUSTOMER, "FOUND LIKE THIS OUT OF PACK" 9/26/2018 JS". HOSPITAL WAS CONTACTED BUT THEY WERE NOT ABLE TO PROVIDE ANY ADDITIONAL EVENT DETAILS.

  Patient problems: No Patient Involvement

  MAUDE report 8075637 ↗
• MalfunctionNov 14, 2018Break; Break

  AS REPORTED BY THE USER FACILITY: DURING THE SAMPLE EVALUATION OF A RETURNED SIMPULSE SOLO IRRIGATOR REPORTED AS NOT PRIMING AND A SLOW/SLUGGISH STREAM, THE LATCH ON THE BATTERY CASE WAS FOUND BROKEN OFF. THE LATCH WAS RETURNED WITH THE SAMPLE. IT WAS NOTED BY THE CUSTOMER ON THE OUTER PACKING OF THE SAMPLE "CAME FROM PACKAGE BROKEN BATTERY PACK". THE BATTERIES HAD BEEN REMOVED FROM THE BATTERY PACK. THE DEVICE DOES NOT APPEAR TO HAVE BEEN USED. HOSPITAL CONTACT WAS NOT ABLE TO PROVIDE ANY DETAILS.

  Patient problems: No Patient Involvement

  MAUDE report 8069816 ↗