Cook G22689Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002226890), received between Mar 18, 2016 and Nov 8, 2016 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2016Difficult to Remove; Naturally Worn; Difficult to Remove; Naturally Worn

  THE FOLLOWING WAS INITIALLY REPORTED TO THE FDA ON (B)(6) 2016: "AFTER THE PLACEMENT OF A COOK BALLOON REPLACEMENT TUBE (PEG-24-BRT-S), AS REPORTED TO CUSTOMER RELATIONS: "GASTROSTOMY TUBE IS IMPLANTED ON (B)(6) 2016 WITH THE LOT W3648518. THE USER IS REFERRED FOR GASTROSTOMY TUBE CHANGE BECAUSE THE CURRENT IS DETERIORATED. THE PHYSICIAN ATTEMPTS TO REMOVE PERCUTANEOUSLY [EXTERNALLY], BUT NOT CAN'T BECAUSE THE FISTULOUS TRACT IS VERY TIGHT. THE PHYSICIAN USES AN ENDOSCOPE AND THE DISTAL PORTION [OF THE DEVICE] IS EXTRACTED USING A POLYPECTOMY SNARE. THE PHYSICIAN REVIEWED DIGESTIVE TRACT WITHOUT FINDING SECONDARY LESIONS, TOLERANCE WAS GOOD, AND THE PATIENT DID NOT POSSESS COMPLICATIONS. A REPLACEMENT PROBE [TUBE] IS USED AND THE BUTTON [TUBE] STAYED IN GOOD POSITION." THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED ON 11/04/2016 FROM THE DISTRIBUTOR: "THE INSTITUTION THAT REPORTED THE INCONVENIENCE RELATED TO MEDICAL DEVICE PEG-24-BRT-S, LOT W3648518, HAS CONFIRMED THAT ALL THE DOCUMENTATION SENT CORRESPONDS TO THE SAME COMPLAINT. ON (B)(6) 2016, DR. (B)(6) IMPLANTED A GASTRONOMY TUBE SET FROM LOT W3648518, TODAY [(B)(6) 2016] THE PATIENT CAME AGAIN TO RE-IMPLANT SINCE THE PRIOR

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6087841 ↗
• MalfunctionMar 18, 2016Material Separation; Material Separation

  DURING AN ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK BALLOON REPLACEMENT TUBE. AS REPORTED TO CUSTOMER RELATIONS: THE PATIENT REALIZED [UNDERWENT] A PROBE EXCHANGE AND WHEN THE DOCTOR INFLATED THE BALLOON, IT HAD BURST. THE DOCTOR REMOVED THE PROBE, OPENED A NEW PROBE AND RESTARTED THE PROCEDURE. THE PROBLEM DOES NOT [DID NOT] OCCUR AGAIN. FROM THE PICTURE RECEIVED WITH THE COMPLAINT, BALLOON MATERIAL LOOKS TO BE MISSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5511243 ↗