InstaClear LCS1870BTSTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925040120), received between Jan 13, 2022 and Jan 13, 2022 — classified as 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K152531); 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.

Recalls naming this device

1. Apr 3, 2024Open, Classified

   Potential for distal end of the sheath to break off during a procedure.

   Z-1888-2024 · Root cause: Under Investigation by firm · FDA record ↗

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.

• MalfunctionJan 13, 2022Contamination; Contamination

  AS REPORTED, FOREIGN MATTER (LIKE A WOOD CHIPS) FOUND INSIDE THE STERILITY PACK . THE DEVICE WAS REPLACED USING THE SAME TYPE OF DEVICE. THE ISSUE WAS FOUND AT PREPARATION FOR USE. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13246908 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152531. One submission often covers many models, so check the product and lot details in each record.

• Z-1368-2024 · Jan 16, 2024 · Open, Classified
  InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1800UNST LCS4K00UNOL LCS1530BTOL LC