ERBEFLO CleverCap® 20325-239Recalls & reported problems
Erbe Medical, LLC · Hybrid CO2 Tubing/Cap Set for Olympus® Scopes & CO2 Sources · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Erbe CleverCap tubing and cap set supplies CO2, air and sterile water to Olympus endoscopes. The 23 adverse event reports mostly describe water leaking or spraying from the scope's tip during procedures; they mention no deaths and 1 injury. One recall, still open and begun in March 2026, involves a connector that may allow unintended water flow with certain third-party connectors. Reports rose from 2 to 17 in the last 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04065655000375), received between Sep 26, 2024 and Sep 9, 2026 — classified as 1 injury, 23 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (18 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Mar 31, 2026Open, Classified
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
Z-2062-2026 · Root cause: Component change control · FDA record ↗
Most reported problems
Device problems
- Leak/Splash18
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
- Low Oxygen Saturation1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Leak/Splash
It was reported that Hybrid CO2 Tubing/Cap Sets for Olympus® Scopes & CO2 leaked at the distal end prior to endoscopic procedures. No other information was provided regarding any other accessory used in the procedure. Specifically, it was reported that there was an unintended flow at the distal end of scopes prior to inserting a scope into a patient. There was no report of any patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50688526 ↗MalfunctionJun 1, 2026Leak/Splash
IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & CO2 LEAKED FROM THE DISTAL END OF THE SCOPE. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350528 ↗MalfunctionMay 27, 2026Leak/Splash
IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SET FOR OLYMPUS® SCOPES & CO2 LEAKED FROM THE DISTAL END OF THE SCOPE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD). THE SET WAS USED WITH A BOSTON SCIENTIFIC PORT CONNECTOR. DURING THE PROCEDURE, THE PATIENTS O2 LEVEL DROPPED; THEREFORE, THEY WERE INTUBATED. NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE O2 LEVEL TO DROP. NEVERTHELESS, AT SOME POINT, THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL.
Patient problems: Low Oxygen Saturation
MAUDE report 25303575 ↗MalfunctionMay 18, 2026Leak/Splash
IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & CO2 INTERMITTENTLY OVER THE PAST 4 WEEKS, THERE IS A CONTINUOUS IRRIGATION STREAM. PHYSICIANS HAVE COMPLAINED ABOUT IT DURING PROCEDURES THAT IT DISTORTS THEIR VISUALIZATION. THE STAFF HAVE COMPLAINED THAT IT WILL LEAK FROM DISTAL END OF SCOPE WHILE WAITING FOR PROCEDURE TO START. OTHER LOT NUMBERS OF THE SAME PART NUMBER [LOT NUMBER (L/N) W4468274, DATE OF MANUFACTURING (DOM) 09/11/25, AND EXPIRATION DATE (EXP. DATE) 09/10/28; L/N W4468275, DOM 09/11/25, AND EXP. DATE 09/10/28; L/N WO469444, DOM 09/25/25, AND EXP. DATE 09/24/28; AND L/N WO469448, DOM 09/25/25, AND EXP. DATE 09/24/28] WERE ALSO A PART OF THE COMPLAINT. THERE WERE NO REPORTS OF ANY PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25199384 ↗MalfunctionMay 4, 2026Leak/Splash
IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SET FOR OLYMPUS® SCOPES & CO2 WAS INVOLVED IN AN INCIDENT DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD). THE SET WAS USED WITH A CO2 INSUFFLATOR [MODEL ECO 2 PLUS, PART NUMBER (P/N) 2N100-068, SERIAL NUMBER (S/N) (B)(6)], IRRIGATION PUMP (MODEL EIP 2, P/N 103250-000, S/N (B)(6), AND A PORT CONNECTOR (P/N 20325-211). SPECIFICALLY, WHEN INSUFFLATING THE STOMACH WITH CO2, WATER SPRAYED FROM THE DISTAL END OF THE SCOPE AS IF THE PEDAL OF THE IRRIGATION PUMP WAS ACTIVATED. UPON TROUBLESHOOTING THE ISSUE DURING THE CASE, THE CO2 FLOW FROM THE INSUFFLATOR WAS REDUCED FROM HIGH TO MEDIUM WHICH RESOLVED THE SPRAYING/LEAKING PROBLEM. THERE WAS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25071343 ↗MalfunctionMay 4, 2026Leak/Splash
IT WAS REPORTED THAT HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & CO2 LEAKED AT THE DISTAL END OF SCOPES DURING ENDOSCOPY. ANOTHER LOT OF THE SAME PART NUMBER (LOT NUMBER WO470913, DATE OF MANUFACTURING 10/13/2025, AND EXPIRATION DATE 10/12/2028) WAS ALSO REPORTED TO HAVE LEAKED DURING PROCEDURES. THE SETS WERE USED WITH A CO2 INSUFFLATOR [MODEL ECO 2 PLUS, PART NUMBER 2N100-068) SET ON HIGH CO2 FLOWRATE AS WELL AS AN IRRIGATION PUMP (MODEL EIP 2, PART NUMBER 10325-000). IN ADDITION, THE SETS WERE USED WITH A PORT CONNECTOR (PART NUMBER 20325-211). NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25071321 ↗MalfunctionApr 29, 2026Leak/Splash
IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & CO2 ARE LEAKING FROM THE DISTAL END OF SCOPES IN NEARLY EVERY UPPER AND LOWER ENDOSCOPY PROCEDURE. THE SETS WERE USED WITH AN ERBE IRRIGATION PUMP, MODEL EIP 2 (PART NUMBER 10325-000) AT 100% FLOWRATE. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25026986 ↗MalfunctionApr 28, 2026Leak/Splash
IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & CO2 ARE LEAKING AT DISTAL END OF THE SCOPES WHEN CO2 INSUFFLATOR IS ACTIVATED. THE SETS ARE BEING USED WITH AN ERBE IRRIGATION PUMP, MODEL EIP 2 (PART NUMBER 10325-000) AT 100% FLOWRATE. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25014216 ↗MalfunctionApr 21, 2026Leak/Splash
IT WAS REPORTED THAT MULTIPLE LOTS OF HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & CO2 ARE LEAKING FROM THE IRRIGATION TUBING IN UPPER AND LOWER ENDOSCOPY (NOTE: THE OTHER SPECIFIC INVOLVED LOTS WERE NOT KNOWN.). NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24941746 ↗MalfunctionApr 20, 2026Leak/Splash
IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & CO2 ARE LEAKING AND THE WATER IS EXITING THE DISTAL END OF THE SCOPES. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927034 ↗MalfunctionApr 20, 2026Leak/Splash
IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & CO2 LEAKED WATER OUT THROUGH THE TIP OF SCOPES. THERE WERE NO REPORTS OF ANY PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24924130 ↗MalfunctionApr 17, 2026Leak/Splash
IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & CO2 INTERMITTENTLY OVER THE PAST 4 WEEKS, THERE IS A CONTINUOUS IRRIGATION STREAM. PHYSICIANS HAVE COMPLAINED ABOUT IT DURING PROCEDURES THAT IT DISTORTS THEIR VISUALIZATION. THE STAFF HAVE COMPLAINED THAT IT WILL LEAK FROM DISTAL END OF SCOPE WHILE WAITING FOR PROCEDURE TO START. OTHER LOT NUMBERS OF THE SAME PART NUMBER [LOT NUMBER (L/N) W4466273, DATE OF MANUFACTURING (DOM) 08/18/25, AND EXPIRATION DATE (EXP. DATE) 08/17/28; L/N W4466275, DOM 08/18/25, AND EXP. DATE 08/17/28; L/N W4466814, DOM 08/26/25, AND EXP. DATE 08/25/28; L/N W4467680, DOM 09/05/25, AND EXP. DATE 09/04/28; L/N WO463714, DOM 07/17/25, AND EXP. DATE 07/16/28; AS WELL AS L/N WO468776, DOM 09/17/25, AND EXP. DATE 09/16/28] WERE ALSO A PART OF THE COMPLAINT. THERE WERE NO REPORTS OF ANY PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24911797 ↗MalfunctionApr 15, 2026Leak/Splash
IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & CO2 CONSTANTLY LEAKED AT THE WHITE CONNECTOR TO THE SCOPE AND INTERMITTENTLY LEAKED AT THE END OF THE SCOPE LINE. ANOTHER LOT NUMBER OF THE SAME PART NUMBER (LOT NUMBER W4466271, DATE OF MANUFACTURING 08/18/25, AND EXPIRATION DATE 08/17/28) WAS ALSO A PART OF THE COMPLAINT. THERE WERE NO REPORTS OF ANY PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24888957 ↗MalfunctionApr 8, 2026Leak/Splash
IT WAS REPORTED THAT FOR APPROXIMATELY TWO (2) WEEKS THE HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & CO2 CONSTANTLY LEAKED FROM THE IRRIGATION LINE. ANOTHER SIMILAR SET (HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & UCR, PART NUMBER 20325-240, LOT NUMBER WO471244, UDI (B)(4), DATE OF MANUFACTURING 10/15/25, AND EXPIRATION DATE 10/14/28) WAS ALSO A PART OF THE COMPLAINT. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24820918 ↗MalfunctionApr 3, 2026Leak/Splash
IT WAS REPORTED THAT HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & CO2 HAVE LEAKED WATER FROM THE DISTAL END OF THE SCOPE DURING PROCEDURES. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24782075 ↗MalfunctionApr 3, 2026Leak/Splash
IT WAS REPORTED THAT HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & CO2 HAVE LEAKED WATER FROM THE DISTAL END OF THE SCOPE DURING PROCEDURES. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24782072 ↗InjuryApr 2, 2026Leak/Splash
IT WAS REPORTED THAT AN INCIDENT OCCURRED WITH A HYBRID CO2 TUBING/CAP SET FOR OLYMPUS® SCOPES & CO2 IN AN ESOPHAGOGASTRODUODENOSCOPY (EDG). PER THE COMPLAINANT, WATER SHOT DOWN THE AIRWAY OF A PATIENT DURING SCOPE INTUBATION INTO THE ORAL PHARYNX. THE PATIENT ASPIRATED WATER BUT WAS DISCHARGED. HOWEVER, THE PATIENT LATER WENT TO THE EMERGENCY ROOM (ER), WAS HOSPITALIZED, AND RECEIVED ANTIBIOTICS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24769489 ↗MalfunctionApr 2, 2026Leak/Splash
IT WAS REPORTED THAT HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & CO2 HAVE LEAKED WATER FROM THE DISTAL END OF THE SCOPE DURING PROCEDURES. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24769458 ↗MalfunctionNov 8, 2024
ERBEFLO TUBING: CO2 DID NOT FLOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20639463 ↗MalfunctionNov 8, 2024
DEFECTIVE: CO2 NOT GOING THROUGH THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20639450 ↗MalfunctionOct 2, 2024
MalfunctionOct 2, 2024
CARBON DIOXIDE (CO2) WAS NOT WORKING ¿ TEAM TROUBLESHOT AND CHECKED CONNECTIONS. CHANGED TO AIR AND STILL WOULD NOT WORK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20350661 ↗MalfunctionSep 26, 2024
DEVICE BROKE, ENTIRE PIECE BROKE OFF THE END DURING SET UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20309079 ↗MalfunctionSep 26, 2024
THERE WAS CRACKED AT THE SCREW CAP THAT INSERTS INTO THE SCOPE AND WATER WOULD SHOOT OUT DURING USE OF THE WATER PEDAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20309056 ↗
Other Pump, Air, Non-Manual, For Endoscope devices
- OLYMPUS OFP-2 (ROW)Keymed (Medical & Industrial Equipment) Limited · Pump, Air, Non-Manual, For Endoscope296 reports
- Olympus MAJ-1651Keymed (Medical & Industrial Equipment) Limited · Pump, Air, Non-Manual, For Endoscope125 reports
- Olympus WB991046OLYMPUS Winter & Ibe GmbH · Pump, Air, Non-Manual, For Endoscope81 reports
- OLYMPUS OFP-2 (US)Keymed (Medical & Industrial Equipment) Limited · Pump, Air, Non-Manual, For Endoscope1 recall22 reports
- ERBEFLO CleverCap® 20325-206Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall5 reports
- ERBEFLO CleverCap® 20325-248Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall3 reports
- ERBEFLO CleverCap® 20325-240Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall3 reports
- ERBEFLO CleverCap® 20325-208Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.