Chait G11632Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002116320), received between Mar 10, 2017 and Feb 21, 2018 — classified as 5 injuries.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2018Device Slipped; Device Slipped

  THE INTERNATIONAL CUSTOMER REPORTED THE FIRST CHANGE OF THE CHAIT PERCUTANEOUS CECOSTOMY CATHETER WAS ON (B)(6) 2018. THE CHAIT CATHETER BUTTON KEPT COMING OUT. THE PRODUCT PROBLEM NECESSITATED THE EXCHANGE OF THE DEVICE ON (B)(6) 2018 IN THE THEATRE. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.

  Patient problems: No Code Available

  MAUDE report 7287881 ↗
• InjuryNov 10, 2017Difficult to Remove; Difficult to Remove

  THE INTERNATIONAL CUSTOMER REPORTED THAT THEY EXPERIENCED DIFFICULTY REMOVING THE CHAIT TUBE OFF OF THE STIFFENED CANNULA OF A CHAIT PERCUTANEOUS CECOSTOMY CATHETER. THE REMOVAL OF THE EXISTING CHAIT TUB WAS REPORTEDLY UNEVENTFUL, BUT WHEN THE FOLEY WAS REMOVED AND THE NEW CHAIT TUBE WAS PLACED OVER THE WIRE ON THE STIFFENED CANNULA, THE DIFFICULTIES WERE EXPERIENCED. EVENTUALLY IT COULD BE REMOVED; HOWEVER, THE 5 MINUTE PROCEDURE WAS EXTENDED TO 45 MINUTES, AND THE PATIENT REPORTED DISCOMFORT. THE DEVICE IS REPORTEDLY NOT AVAILABLE FOR RETURN.

  Patient problems: Discomfort; No Code Available

  MAUDE report 7022462 ↗
• InjuryMar 10, 2017Leak/Splash; Leak/Splash

  INTERNATIONAL CUSTOMER REPORTED THAT A CHAIT PERCUTANEOUS CECOSTOMY CATHETER WAS LEAKING. THE DATE OF THE EVENT WAS NOT PROVIDED. THE DATE OF INITIAL IMPLANT IS NOT KNOWN. ADDITIONAL EVENT AND PATIENT INFORMATION WAS REQUESTED. NO FURTHER INFORMATION WAS RECEIVED. IT IS OPINED THAT THE DEVICE REQUIRED REPLACEMENT. THE INSTRUCTIONS FOR USE THAT ACCOMPANY EACH DEVICE PROVIDES PRECAUTIONS THAT "THE CATHETER SHOULD BE CHANGED EVERY 6 MONTHS TO REDUCE THE RISK OF CATHETER FRACTURE IN THE PATIENT." INSTRUCTIONS FOR CATHETER EXCHANGE STATE "INTRODUCE AN APPROPRIATE WIRE GUIDE... THROUGH THE CHAIT TRAPDOOR CECOSTOMY CATHETER AND INTO THE CECUM. REMOVE CATHETER LEAVING WIRE GUIDE IN PLACE. INTRODUCE NEW CHAIT TRAPDOOR CECOSTOMY CATHETER OVER WIRE GUIDE AND ADVANCE INTO POSITION."

  Patient problems: No Code Available

  MAUDE report 6396513 ↗
• InjuryMar 10, 2017Leak/Splash; Leak/Splash

  INTERNATIONAL CUSTOMER REPORTED THAT A CHAIT PERCUTANEOUS CECOSTOMY CATHETER WAS LEAKING. THE DATE OF INITIAL IMPLANT IS NOT KNOWN. THE CUSTOMER REPORTS THIS EVENT OCCURRED IN (B)(6) 2016. ADDITIONAL EVENT AND PATIENT INFORMATION WAS REQUESTED. NO FURTHER INFORMATION WAS RECEIVED. IT IS OPINED THAT THE DEVICE REQUIRED REPLACEMENT. THE INSTRUCTIONS FOR USE THAT ACCOMPANY EACH DEVICE PROVIDES PRECAUTIONS THAT "THE CATHETER SHOULD BE CHANGED EVERY 6 MONTHS TO REDUCE THE RISK OF CATHETER FRACTURE IN THE PATIENT." INSTRUCTIONS FOR CATHETER EXCHANGE STATE "INTRODUCE AN APPROPRIATE WIRE GUIDE... THROUGH THE CHAIT TRAPDOOR CECOSTOMY CATHETER AND INTO THE CECUM. REMOVE CATHETER LEAVING WIRE GUIDE IN PLACE. INTRODUCE NEW CHAIT TRAPDOOR CECOSTOMY CATHETER OVER WIRE GUIDE AND ADVANCE INTO POSITION."

  Patient problems: No Code Available; No Information

  MAUDE report 6396214 ↗
• InjuryMar 10, 2017Leak/Splash; Leak/Splash

  INTERNATIONAL CUSTOMER REPORTED THAT A CHAIT PERCUTANEOUS CECOSTOMY CATHETER WAS LEAKING. THE DATE OF THE EVENT WAS NOT PROVIDED. THE DATE OF INITIAL IMPLANT IS NOT KNOWN. ADDITIONAL EVENT AND PATIENT INFORMATION WAS REQUESTED. NO FURTHER INFORMATION WAS RECEIVED. IT IS OPINED THAT THE DEVICE REQUIRED REPLACEMENT. THE INSTRUCTIONS FOR USE THAT ACCOMPANY EACH DEVICE PROVIDES PRECAUTIONS THAT "THE CATHETER SHOULD BE CHANGED EVERY 6 MONTHS TO REDUCE THE RISK OF CATHETER FRACTURE IN THE PATIENT." INSTRUCTIONS FOR CATHETER EXCHANGE STATE " INTRODUCE AN APPROPRIATE WIRE GUIDE... THROUGH THE CHAIT TRAPDOOR CECOSTOMY CATHETER AND INTO THE CECUM. REMOVE CATHETER LEAVING WIRE GUIDE IN PLACE. INTRODUCE NEW CHAIT TRAPDOOR CECOSTOMY CATHETER OVER WIRE GUIDE AND ADVANCE INTO POSITION."

  Patient problems: No Code Available

  MAUDE report 6395939 ↗