Simpulse 0067621Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741010279), received between Apr 17, 2020 and Apr 17, 2020 — classified as 5 malfunctions.

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

• MalfunctionApr 17, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE OPENING THE STERILIZED PACKAGE, DUST WAS ALLEGEDLY FOUND IN THE STERILIZED PACKAGE. THE PRODUCT REFERENCE NUMBER IS SUPPLIED IN A CASE OF 10. AS REPORTED, 5 DEVICES OF THE CASE OF 10 WERE NOTED TO HAVE A "DUST" INSIDE THE PACKAGING. ALL OF THE PACKAGES WERE UNOPENED. THERE WAS NO DAMAGE NOTED TO THE PRODUCT OR SHIPPING PACKAGES. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9973087 ↗
• MalfunctionApr 17, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE OPENING THE STERILIZED PACKAGE, DUST WAS ALLEGEDLY FOUND IN THE STERILIZED PACKAGE. THE PRODUCT REFERENCE NUMBER IS SUPPLIED IN A CASE OF 10. AS REPORTED, 5 DEVICES OF THE CASE OF 10 WERE NOTED TO HAVE A "DUST" INSIDE THE PACKAGING. ALL OF THE PACKAGES WERE UNOPENED. THERE WAS NO DAMAGE NOTED TO THE PRODUCT OR SHIPPING PACKAGES. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9973086 ↗
• MalfunctionApr 17, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE OPENING THE STERILIZED PACKAGE, DUST WAS ALLEGEDLY FOUND IN THE STERILIZED PACKAGE. THE PRODUCT REFERENCE NUMBER IS SUPPLIED IN A CASE OF 10. AS REPORTED, 5 DEVICES OF THE CASE OF 10 WERE NOTED TO HAVE A "DUST" INSIDE THE PACKAGING. ALL OF THE PACKAGES WERE UNOPENED. THERE WAS NO DAMAGE NOTED TO THE PRODUCT OR SHIPPING PACKAGES. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9973084 ↗
• MalfunctionApr 17, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE OPENING THE STERILIZED PACKAGE, DUST WAS ALLEGEDLY FOUND IN THE STERILIZED PACKAGE. THE PRODUCT REFERENCE NUMBER IS SUPPLIED IN A CASE OF 10. AS REPORTED, 5 DEVICES OF THE CASE OF 10 WERE NOTED TO HAVE A "DUST" INSIDE THE PACKAGING. ALL OF THE PACKAGES WERE UNOPENED. THERE WAS NO DAMAGE NOTED TO THE PRODUCT OR SHIPPING PACKAGES. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9973082 ↗
• MalfunctionApr 17, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE OPENING THE STERILIZED PACKAGE, DUST WAS ALLEGEDLY FOUND IN THE STERILIZED PACKAGE. THE PRODUCT REFERENCE NUMBER IS SUPPLIED IN A CASE OF 10. AS REPORTED, 5 DEVICES OF THE CASE OF 10 WERE NOTED TO HAVE A "DUST" INSIDE THE PACKAGING. ALL OF THE PACKAGES WERE UNOPENED. THERE WAS NO DAMAGE NOTED TO THE PRODUCT OR SHIPPING PACKAGES. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9973081 ↗