Endo SmartCap 100164CO2EXTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00677964111075), received between Dec 14, 2023 and Feb 20, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 reports).

7 other recalls cover devices cleared under the same FDA submission (K093665); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Leak/Splash

  THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THE SCOPE AIR/WATER VALVE DURING USE OF MULTIPLE OF THEIR ENDO SMARTCAP TUBING DEVICES. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401777 ↗
• MalfunctionJan 28, 2026Leak/Splash

  THE USER FACILITY REPORTED THAT WATER WAS SPRAYING FROM THE AIR/WATER VALVE DURING A PROCEDURE WHICH INCLUDED USE OF THE ENDO SMARTCAP TUBING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203869 ↗
• MalfunctionJan 21, 2026Leak/Splash

  THE USER FACILITY REPORTED THAT WATER WAS SPRAYING FROM THE AIR/WATER VALVE DURING A PROCEDURE WHICH INCLUDED USE OF THE ENDO SMARTCAP TUBING. USER FACILITY PERSONNEL REPLACED THE TUBING AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24135695 ↗
• MalfunctionDec 14, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE PINCH CLIP TO THEIR ENDO SMARTCAP TUBING WAS NOT OPERATING PROPERLY. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18332506 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093665. One submission often covers many models, so check the product and lot details in each record.

• Z-1772-2020 · Oct 9, 2019 · Terminated
  Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50, and found in BMP-C145. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endosco
• Z-1778-2020 · Oct 9, 2019 · Terminated
  Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to sup
• Z-1774-2020 · Oct 9, 2019 · Terminated
  Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10, 50. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes With Extend
• Z-1777-2020 · Oct 9, 2019 · Terminated
  Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigati
• Z-1776-2020 · Oct 9, 2019 · Terminated
  Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scientific Endostat II Irrigation Pump Units. C
• Z-1775-2020 · Oct 9, 2019 · Terminated
  Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10, 50, and found in BMP-C145CO2EXT. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 S
• Z-1773-2020 · Oct 9, 2019 · Terminated
  Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50 and found in BMP-C145CO2. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series E