ReNew 3915Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811099010586), received between Oct 9, 2019 and Oct 9, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2019Material Fragmentation; Material Fragmentation

  DISTAL PORTION OF BLACK INSULATION OF RENEW HANDPIECE CRACKED INTO MULTIPLE SEGMENTS AND FELL OFF AND INTO PATIENT ABDOMEN DURING PROCEDURE. SOME OF THE INSULATION WAS RETRIEVED, HOWEVER NOT ALL WAS ABLE TO BE FOUND OR RECOVERED FROM ABDOMEN AS STATED BY STAFF AT THE TIME OF INCIDENT. SURGEON ATTEMPTED TO RECOVER ALL PORTIONS OF INSULATION BUT WAS NOT ABLE TO.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9171872 ↗