Simpulse 0067730Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741010323), received between Feb 28, 2019 and Feb 15, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A LEFT KNEE STAGE REVISION JOINT REPLACEMENT PROCEDURE, THE SIMPULSE SOLO IRRIGATOR WAS USED AND THE SURGEON NOTICED THAT THE PURPLE SMALL TIP (SHOWERHEAD FACEPLATE) WAS NO LONGER ATTACHED PRIOR TO CLOSURE. THE MISSING PIECE WAS ATTEMPTED TO BE LOCATED IN THE SURGICAL SITE; HOWEVER, WAS UNABLE TO BE FOUND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16380399 ↗
• MalfunctionMay 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE ON (B)(6) 2021, THE PURPLE PART TIP OF THE BARD/DAVOL SIMPULSE SOLO BECAME DETACHED AND FELL INTO THE PATIENT¿S BODY; ALL PIECES WERE REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821261 ↗
• MalfunctionFeb 28, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED BY THE USER FACILITY THAT THE INNER PURPLE TIP ON THE SIMPULSE SOLO SPLASHSHIELD TIP ALLEGEDLY DETACHED INTRA-OPERATIVELY. ADDITIONAL INFORMATION WAS REQUESTED. THERE WAS NO PATIENT INJURY OR COMPLICATION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8380138 ↗