Chait G12685Recalls & reported problems
Cook Incorporated · Chait Trapdoor Cecostomy Catheter Set · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002126855), received between Mar 24, 2017 and Mar 21, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- Insufficient Information1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 21, 2024Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 18950353 ↗MalfunctionJun 23, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT RECEIVED A CHAIT PERCUTANEOUS CECOSTOMY CATHETER ON AN UNSPECIFIED DATE. THE PATIENT REPORTED TO THE CLINICAL STAFF THAT THE CAP OF THE DEVICE CAME OFF FOUR WEEKS AFTER INSERTION. THE CLINICAL STAFF REPORTS THAT IT IS BELIEVED THAT THE PATIENT HAD PULLED THE CAP OFF OR CUT THE TUBE OFF HERSELF ON OR ABOUT (B)(6) 2017. THE CHAIT WAS PREVIOUSLY FLUSHED IN THE HOSPITAL OPERATING ROOM AND POST OP WITHOUT ANY COMPLICATIONS. THE PATIENT REPORTEDLY COULD NOT ACCESS THE DEVICE AND THEREFORE COULD NOT EMPTY HER BOWEL. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6662623 ↗InjuryMar 24, 2017Break; Break
THE CUSTOMER REPORTED THAT THE CHAIT PERCUTANEOUS CECOSTOMY CATHETER IS BREAKING AT AN UNSPECIFIED TIME FOLLOWING IMPLANTATION. THE DEVICE REPORTEDLY BROKE AT THE JUNCTION OF THE CATHETER AND THE PATIENT EXTERNALIZED PORTION OF THE HUB. THE BROKEN CATHETER WAS EXPLANTED AND REPLACED WITH A NEW DEVICE. THE HANDLING CONDITIONS AND CIRCUMSTANCES SURROUNDING THE EVENT ARE NOT KNOWN. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED. THE DEVICE WAS RETURNED FOR EVALUATION.
Patient problems: No Code Available
MAUDE report 6430957 ↗
Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices
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- Bard Tri-Funnel Replacement Gastrostomy Tube 000720Bard Access Systems, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death170 reports
- EndoVive Safety PEG Kit M00566470Boston Scientific Corporation · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 reports
- NutraGlide Nasal Feeding Tube ENFT-05055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.