InstaClear LCS4K30BTOLRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00821925041486), received between Nov 23, 2020 and Jan 13, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).

2 other recalls 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC SINUS SURGERY (ESS) PROCEDURE, THE STOPPER AT THE TIP OF THE INSTACLEAR SHEATH BROKE AND FELL INTO THE PATIENT'S NASAL CAVITY. THE BROKEN FRAGMENT WAS RETRIEVED USING FORCEPS. AFTER THE RETRIEVAL, A VISUAL CHECK CONFIRMED NO RESIDUAL FRAGMENTS REMAINED. THE PROCEDURE WAS THEN COMPLETED USING A REPLACEMENT OF THE SAME DEVICE. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053917 ↗
• MalfunctionFeb 5, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT WHEN INSTALLING THE DISPOSABLE SHEATH, THE SHEATH WAS OBSERVED TO HAVE JAGGED EDGES AND WAS NOT ABLE TO BE USED. THE CUSTOMER REPORTED THAT THE ISSUE WAS NOTICED OUT-OF-BOX. THERE WAS NO PATIENT OR USER HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315265 ↗
• MalfunctionAug 8, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE INSTACLEAR SHEATH TIP OF THE SAMPLE SHEATH WAS FUZZY. THE EVENT OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937515 ↗
• MalfunctionAug 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INSTACLEAR SHEATH TIP CAME OFF OUTSIDE OF THE PATIENT¿S BODY. THE EVENT OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937509 ↗
• MalfunctionAug 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LENS CLEANING SHEATH WAS DEFECTIVE. THE ISSUE WAS FOUND AT THE START OF A THERAPEUTIC FUNCTIONAL ENDOSCOPIC SINUS SURGERY, WHICH WAS COMPLETED WITH A REPLACEMENT DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934386 ↗
• MalfunctionAug 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LENS CLEANING SHEATH TIP WAS ABOUT TO COME OFF THE SHEATH. THE ISSUE WAS FOUND DURING A PROCEDURE, WHICH WAS COMPLETED WITH A REPLACEMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934211 ↗
• MalfunctionJul 11, 2023Contamination; Contamination

  IT WAS REPORTED TWO BLACK STAINS OF ABOUT 0.5 MM WERE FOUND ON THE INNER PAPER. THE ISSUE WAS FOUND BEFORE OPENING THE STERILIZED PACK. THE DEVICE WAS REPLACED AND THE PROCEDURE (AN UNSPECIFIED PROCEDURE) WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT HARM, NO INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17296072 ↗
• MalfunctionNov 23, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PREPARATION FOR USE FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THE USER OPENED THE LCS4K30BTO DEVICE AND FOUND THAT THE STOPPER AT THE TIP OF THE SHAFT WAS FOUND ROLLED UP,DEFORMED. THE DEVICE WAS REPLACED WITH SIMILAR DEVICE AND THE INTENDED PROCEDURE WAS COMPLETED. NO PATIENT HARM OR IMPACT WAS REPORTED. NO USER INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10887033 ↗

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-1888-2024 · Apr 3, 2024 · Open, Classified
  InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remo
• 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