EnVisio System ENVISIO-SYSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851674008553), received between Apr 29, 2026 and Apr 29, 2026 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K183400); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  DURING A LUMPECTOMY PROCEDURE, THE PHYSICIAN REPORTED A DISCREPANCY BETWEEN THE EXPECTED CLIP LOCATION AND THE SYSTEM-INDICATED LOCATION. INITIAL SPECIMENS DID NOT INCLUDE THE CLIP; THE CLIP WAS RETRIEVED IN A SUBSEQUENT EXCISION. THE PHYSICIAN REPORTED THE FINAL SPECIMEN WAS LARGER THAN INITIALLY PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034309 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183400. One submission often covers many models, so check the product and lot details in each record.

• Z-0806-2025 · Nov 18, 2024 · Open, Classified
  EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation S