Simpulse 0057621Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741010415), received between Oct 17, 2019 and Mar 24, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY THE USER FACILITY CONTACT THAT FOREIGN MATERIAL WAS NOTED PRIOR TO OPENING THE PACKAGE OF THE BARD/DAVOL SIMPULSE PLUS IRRIGATOR ON (B)(6) 2021. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11564089 ↗
• MalfunctionAug 6, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING INSPECTION AT THE HOSPITAL WAREHOUSE, AN UNKNOWN PARTICULATE WAS OBSERVED INSIDE THE SIMPULSE PLUS SHOWERHEAD TIP SUCTION IRRIGATOR PACKAGE. THERE WAS NO PATIENT INVOLVEMENT AS THE REPORTED PRODUCT ISSUE WAS DISCOVERED DURING INSPECTION.

  Patient problems: No Patient Involvement

  MAUDE report 10372998 ↗
• MalfunctionAug 6, 2020Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING INSPECTION AT THE HOSPITAL WAREHOUSE, AN UNKNOWN PARTICULATE WAS OBSERVED INSIDE THE SIMPULSE PLUS SHOWERHEAD TIP SUCTION IRRIGATOR PACKAGE. THERE WAS NO PATIENT INVOLVEMENT AS THE REPORTED PRODUCT ISSUE WAS DISCOVERED DURING INSPECTION.

  Patient problems: No Patient Involvement

  MAUDE report 10372555 ↗
• MalfunctionAug 6, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING INSPECTION AT THE HOSPITAL WAREHOUSE, AN UNKNOWN PARTICULATE WAS OBSERVED INSIDE THE SIMPULSE PLUS SHOWERHEAD TIP SUCTION IRRIGATOR PACKAGE. THERE WAS NO PATIENT INVOLVEMENT AS THE REPORTED PRODUCT ISSUE WAS DISCOVERED DURING INSPECTION.

  Patient problems: No Patient Involvement

  MAUDE report 10372551 ↗
• MalfunctionOct 17, 2019Loss of or Failure to Bond; Detachment of Device or Device Component; Loss of or Failure to Bond; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL HIP PROCEDURE, THE TIP OF THE SIMPULSE PLUS SHOWERHEAD TIP FELL OFF DURING SURGERY. IT IS UNKNOWN IF EXCESSIVE PRESSURE WAS BEING APPLIED AT THE TIME OF THE REPORTED DETACHMENT. ALL DETACHED PIECES OF THE DEVICE WERE RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9204408 ↗