EnVisio ENVISIO-SYSRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00851674008034), received between Sep 21, 2023 and Feb 20, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Device Sensing Problem

  A LOCALIZATION CLIP WAS IMPLANTED TO MARK A TARGET LESION PRIOR TO SURGICAL EXCISION. DURING THE SUBSEQUENT PROCEDURE, THE SYSTEM BRIEFLY DETECTED THE CLIP BUT WAS UNABLE TO MAINTAIN LOCALIZATION, AND THE PROCEDURE COULD NOT BE COMPLETED AS INTENDED. THE PATIENT LATER UNDERWENT A SECOND PROCEDURE DURING WHICH AN ADDITIONAL CLIP WAS IMPLANTED TO FACILITATE LOCALIZATION AND EXCISION. THE LESION WAS SUCCESSFULLY REMOVED. PATHOLOGY CONFIRMED BOTH CLIPS WERE PRESENT IN THE EXCISED SPECIMEN. THE DEVICES WERE NOT RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24408347 ↗
• InjuryJun 10, 2025Use of Incorrect Control/Treatment Settings; Malposition of Device; Device Dislodged or Dislocated; Use of Incorrect Control/Treatment Settings; Malposition of Device; Device Dislodged or Dislocated

  THREE CLIPS WERE IMPLANTED TO LOCALIZE A TARGET. POST-IMPLANT IMAGING REVEALED ALL THREE CLIPS TO BE POSITIONED OUTSIDE OF THE LESION. DURING THE SUBSEQUENT SURGICAL PROCEDURE, TWO CLIPS WERE BRACKETED TO GUIDE TISSUE EXCISION. UPON REMOVAL OF THE LOCALIZED SPECIMEN, ONLY ONE CLIP WAS CONFIRMED WITHIN THE EXCISED TISSUE. THE REMAINING TWO CLIPS WERE NOT RETRIEVED, NECESSITATING A SECOND SURGICAL EXCISION TO LOCATE AND REMOVE THE RESIDUAL MARKERS AND THE TARGET LESION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22181430 ↗
• InjuryJun 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING NAVIGATION, THE SMARTCLIP WAS DISPLACED FROM THE TARGET LOCATION. THE DISPLACEMENT OF THE SMARTCLIP PREVENTED SURGICAL NAVIGATION RESULTING IN INCOMPLETE REMOVAL OF THE TARGET TISSUE. A SECOND SURGICAL PROCEDURE WAS REPORTED TO BE REQUIRED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22142107 ↗
• InjuryJan 29, 2025Device Sensing Problem; Device-Device Incompatibility; Device Sensing Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING NAVIGATION, THE ENVISIO SYSTEM WAS NOT CONSISTENTLY DISPLAYING NAVIGATION TO THE TARGETED CLIP. AFTER THE CASE WAS CONCLUDED, THE GROUNDING PAD WAS FOUND TO BE OVERLAPPING THE PATIENT PAD. WHEN THE GROUNDING PAD WAS REMOVED, A BLISTER WAS FOUND ON THE PATIENT BENEATH WHERE THE GROUNDING PAD WAS PLACED.

  Patient problems: Blister

  MAUDE report 21268651 ↗
• MalfunctionNov 15, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DURING A CASE WHICH WAS SETUP WITH THE ENVISIO NAVIGATION SYSTEM, IT WAS REPORTED THAT THE SKYTRON 6702 OR BED WAS INCLINED TO A NEAR VERTICAL POSITION. AS THE BACK SECTION OF THE OR BED INCLINED A COMPONENT OF THE ENVISIO NAVIGATION SYSTEM, THE ENVISIO PATIENT PAD TRANSITION PAD WAS COMPRESSED BETWEEN THE X-RAY RISERS ON THE BACK AND SEAT SECTIONS OF THE OR BED. THE COMPRESSION OF THE PATIENT PAD TRANSITION CUSHION CAUSED SUFFICIENT BACK PRESSURE TO CAUSE THE BACK PORTION OF THE SKYTRON OR BED BECAME DISASSOCIATED FROM THE BED FRAME. THERE WAS NO REPORTED PATIENT INJURY RESULTING FROM THIS EVENT. ELUCENT IS FILING THIS REPORT DUE TO THE POTENTIAL FOR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20697053 ↗
• InjuryApr 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DURING A CASE USING THE ENVISIO¿ NAVIGATION SYSTEM, IT WAS REPORTED THAT TWO 'PINK' SMARTCLIPS WERE IMPLANTED IN THE SAME PATIENT. THIS EVENT COINCIDED WITH EXCESS TISSUE REMOVAL FROM THE PATIENT. (SMARTCLIP SOFT TISSUE MARKERS ARE AVAILABLE IN THREE DIFFERENT VERSIONS, PINK, GREEN AND PURPLE. THE SMARTCLIP VERSIONS ARE IDENTICAL IN MATERIALS OF CONSTRUCTION, BUT ARE DIFFERENTIATED BY DIFFERENT FREQUENCIES THEY EMIT WHEN LOCALIZED BY THE ENVISIO NAVIGATION SYSTEM).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19197641 ↗
• InjurySep 21, 2023Erratic or Intermittent Display; Electrical /Electronic Property Problem; Erratic or Intermittent Display; Electrical /Electronic Property Problem

  DURING A CASE USING THE ENVISIO¿ NAVIGATION SYSTEM, IT WAS REPORTED THAT THE SYSTEM NAVIGATION WAS SLOW OR LAGGING. THIS EVENT COINCIDED WITH EXCESS TISSUE REMOVAL FROM THE PATIENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17789290 ↗

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