Stretta 8800Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00856219002294), received between Apr 4, 2017 and Jan 7, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Nonstandard Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryJan 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDERI RF WAS CONTACTED POST PROCEDURE FROM A PHYSICIAN REGARDING A PATIENT'S STRETTA PROCEDURE. THE PHYSICIAN PERFORMED THE PROCEDURE SUCCESSFULLY AND INDICATED THERE WERE NO COMPLICATIONS WITH PERFORMANCE OF THE PRODUCT DURING THE PROCEDURE. THE PATIENT CONTACTED THE PHYSICIAN REGARDING AN ADVERSE EVENT THE PATIENT BELIEVES MAY HAVE BEEN IN RELATION TO THE PROCEDURE.

  Patient problems: Pericarditis

  MAUDE report 13195495 ↗
• MalfunctionApr 4, 2017Nonstandard Device; Tear, Rip or Hole in Device Packaging; Nonstandard Device; Tear, Rip or Hole in Device Packaging

  A COMPANY FIELD REPRESENTATIVE NOTED A PRODUCT PROBLEM AND IT WAS CONFIRMED BY THE COMPANY THROUGH INSPECTION OF INTERNAL INVENTORY THAT THE PROBLEM COULD RESULT IN A BREACH IN THE PACKAGING.

  Patient problems: No Patient Involvement

  MAUDE report 6456594 ↗