Passport G24612Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002246126), received between Dec 4, 2017 and Aug 23, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2019Break; Break

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK PASSPORT LOW PROFILE GASTROSTOMY DEVICE. THE PATIENT UNDERWENT AN ATTEMPT TO CHANGE A GASTROSTOMY DEVICE, HOWEVER, IT WAS NOT POSSIBLE BECAUSE DURING THE TRACTION OF THE BUTTON TIP FOR INTRODUCTION INTO THE STOMACH, IT [THE BUTTON] WAS INJURED [TORN] EVEN WITH MINIMAL TRACTION. THE PROCEDURE WAS COMPLETED USING ANOTHER MATERIAL." THE PHOTO PROVIDED DEPICTS A HOLE IN THE BOTTOM OF THE BUTTON. THE PHOTO RECEIVED INDICATES THAT THE TIP OF THE PASSPORT IS MISSING. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8926215 ↗
• MalfunctionJun 26, 2018Break; Break

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK PASSPORT LOW PROFILE GASTROSTOMY DEVICE. DURING AN ATTEMPT TO PLACE THE GASTROSTOMY BUTTON, THE END OF THE DEVICE RUPTURED, MAKING IT IMPOSSIBLE TO PLACE. THE DEVICE PHOTO WAS RE-EVALUATED ON 25-JUNE-2018: A SMALL PORTION OF THE DISTAL TIP APPEARS TO BE MISSING. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7639763 ↗
• InjuryDec 4, 2017Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  THE FOLLOWING WAS INITIALLY PROVIDED ON 12/04/2017: "THE FOLLOWING INFORMATION WAS PROVIDED TO COOK BY THE USER REGARDING A COOK PASSPORT LOW PROFILE GASTROSTOMY DEVICE: THE DOCTOR REPORTED THE SIGNIFICANT INCREASE IN THE INCIDENCE OF BURIED BUMPER CASES OCCURRING WITH THESE BUTTONS. A BURIED BUMPER IS A MAJOR COMPLICATION IN PATIENTS USING GASTROSTOMY, WHICH OCCURS DUE TO MIGRATION OF THE BUTTON FROM THE GASTRIC CHAMBER TOWARDS THE SKIN, WITH A RISK OF FISTULOUS PATH, PERITONITIS, WALL NECROSIS, SEPSIS AND EVEN DEATH. ANOTHER PROCEDURE WAS REQUIRED TO PLACE A NEW GASTROSTOMY. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. INFORMATION RECEIVED DURING A TELECONFERENCE WITH THE DISTRIBUTOR ON 11/08/2017: THE DEVICES WERE USED ON PEDIATRIC PATIENTS (THIS DEVICE IS NOT INTENDED FOR PEDIATRIC POPULATION). THE PATIENT ONLY REQUIRED A NEW PASSPORT DEVICE IN THE OLD STOMA (SUBJECT OF THIS REPORT). THERE ARE PICTURES OF TWO PATIENTS. A TRANSLATION OF THE PHYSICIAN'S ORIGINAL EMAIL WAS RECEIVED ON 11/09/2017: THERE ARE MAJOR AND MINOR COMPLICATIONS. IN MINOR, THERE IS LEAKAGE IN THE UNIDIRECTIONAL VALVE, JUST AFTER THE INSERTION OF THE PROBE, WITH NEW PROCEDURES NEEDED. HOWEVER, OUR MAJOR

  Patient problems: Hyperemia; No Consequences Or Impact To Patient; Unspecified Infection

  MAUDE report 7080845 ↗