ILLUMISITE ILS-1000-CS (UDI 10884521842915)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521842915), received between Jun 19, 2025 and Jul 25, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K191394); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2025Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, AT THE BEGINNING OF THE PROCEDURE, THE NAVIGATION CATHETER WAS NOT DETECTED. THE CONTINUOUS GUIDANCE MODULE WAS NOT WORKING AS THERE WAS AN ERROR MESSAGE INDICATED (OUT OF THE SENSING VOLUME). TO RESOLVE THE ISSUE, THE CONTINUOUS GUIDANCE MODULE WAS REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 22613830 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE PROCEDURE, A PNEUMOTHORAX WAS IDENTIFIED POST-OPERATIVELY, WHICH WAS NOT APPARENT DURING THE CASE. A FEW HOURS AFTER THE PROCEDURE, A POST-OPERATIVE NURSE NOTED THAT THE PATIENT HAD A SMALL PNEUMOTHORAX. ADDITIONAL IMAGING WAS CONDUCTED TO ASSESS THE PROGRESSION OF THE PNEUMOTHORAX. THE ATTENDING PHYSICIAN DETERMINED THAT THE PNEUMOTHORAX HAD PROGRESSED. A CHEST TUBE WAS SUBSEQUENTLY PLACED DUE TO THE PNEUMOTHORAX. THE PATIENT WAS IN THE HOSPITAL FOR 4 EXTRA DAYS.

  Patient problems: Pneumothorax

  MAUDE report 22290458 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191394. One submission often covers many models, so check the product and lot details in each record.

• Z-2008-2023 · May 22, 2023 · Open, Classified
  Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS