PEG 24 G22757Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002227576), received between Jun 23, 2017 and Nov 11, 2025 — classified as 1 injury, 5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Collapse; Collapse

  IN PREPARATION FOR A PEG PLACEMENT, THE PHYSICIAN CHOSE A PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET: PULL. WHILE OPENING THE KIT, THE TROCAR CANNULA WAS FOUND FAULTY AND THE TROCAR NEEDLE PLASTIC SHEATH WAS TORN. THIS OCCURRED PRIOR TO USE; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23527292 ↗
• MalfunctionMay 23, 2025Collapse; Collapse

  DURING A FEEDING TUBE PLACEMENT, THE PHYSICIAN USED A COOK PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL. IT WAS REPORTED THAT USING THE KNIFE INCLUDED IN THE KIT, A SMALL INCISION WAS MADE, AND THEN THE ABDOMEN WAS PUNCTURED WITH THE ENCLOSED NEEDLE. HOWEVER, THE NEEDLE DID NOT PENETRATE WELL, AND THE SHEATH ON THE NEEDLE SURFACE WAS PUSHED BACK. PER THE PHOTO PROVIDED THE WHITE SHEATH ON THE TROCAR NEEDLE IS KINKED/ACCORDIONED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080480 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PERCUTANEOUS GASTROSTOMY TUBE PLACEMENT, THE PHYSICIAN USED A COOK PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL. THE FOLLOWING WAS REPORTED: THE DEVICE WAS INSERTED ON (B)(6) 2019 AND DISLODGED ON (B)(6) 2019. THE CAREGIVER FOUND THAT PUS WAS EXCRETING FROM THE STOMA AND THE SKIN NEAR THE TUBE ON THE STOMACH OF THE PATIENT WAS REDDISH IN APPEARANCE. THE PATIENT WAS NOT IN THE HOSPITAL, THE PATIENT WAS RUSHED TO THE HOSPITAL WHEN THE CAREGIVER NOTICED THE PUS EXCRETION AND THE REDDISH APPEARANCE ON THE STOMACH. THEN ONLY THE MO [HEALTHCARE PROFESSIONAL IN HOSPITAL] EXPLANTED THE DEVICE PRIOR BEING CONSULTED BY THE PHYSICIAN. THE DEVICE WAS INITIALLY PLACED THROUGH A NEW ABDOMINAL INCISION WHICH WAS APPROXIMATELY 1 CM. THE FOLLOWING WAS RECEIVED ON 01-OCT-2019: THE DEVICE DISLODGED AND WAS PUT BACK IN. THE DEVICE WAS THEN EXPLANTED IN THE HOSPITAL AFTER SEEING PUS AND REDNESS ON SKIN. UNKNOWN TREATMENT WAS PERFORMED FOR THE PUS AND REDNESS. THE FOLLOWING WAS RECEIVED 03-OCT-2019: [THE PHYSICIAN] CLAIMS THAT A DEBRIDEMENT WAS DONE ON THE PATIENT; AND ANTIBIOTICS AS TREATING LIKE NECROTIZING. [THE PHYSICIAN] SUSPECTS THAT MAYBE THE PATIENT YANKED THE PEG TUBE. THUS, I

  Patient problems: Unspecified Infection

  MAUDE report 9194601 ↗
• MalfunctionJul 16, 2019Break; Break

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL. THE DEVICE WAS PLACED IN THE PATIENT ACCORDING TO THE INSTRUCTIONS. THE CAP [BOLSTER] DETACHED ONE (1) WEEK AFTER PLACEMENT OF THE DEVICE. THE DEVICE WITH THE CAP DETACHED WAS REPLACED BY ANOTHER OF THE SAME PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 04-JUL-2019 INDICATING THAT THE DETACHED PORTION WAS THE BOLSTER OF THE DEVICE. ADDITIONAL INFORMATION WAS RECEIVED ON 15-JUL-2019: THE DETACHED PORTION WAS ALLOWED TO PASS NATURALLY. THE BOLSTER REMAINED INSIDE THE PATIENT¿S BODY TO PASS NATURALLY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

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

  MAUDE report 8795218 ↗
• MalfunctionJan 3, 2019Break; Break

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL. THE DISTRIBUTION REPRESENTATIVE SAID THE LOOP OF THE PEG TUBE WAS BROKEN [WHEN THEY] OPENED THE BOX. THE IMAGE PROVIDED BY THE DISTRIBUTOR ON 07-NOV-2018 SHOWS THAT THERE IS NOT A SNARE LOOP ON THE DEVICE. THE DEVICE WAS EVALUATED ON 18-DEC-2018: PER VISUAL EXAMINATION, A PORTION OF LOOP WIRE APPEARS TO REMAIN INSIDE THE CANNULA. A SMALL WIRE CAN BE PASSED PARTIALLY THROUGH THE CANNULA, BUT NOT COMPLETELY THROUGH. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8215047 ↗
• MalfunctionJun 23, 2017Material Separation; Material Separation

  THE FOLLOWING INFORMATION WAS PROVIDED TO COOK BY THE USER: AFTER A PEG CASE, THE FEEDING TUBE MIGRATED [DETERMINED ON (B)(6) 2017 TO MEAN "PULLED OUT"]. THE USER HAD SELECTED A COOK PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL. DURING INSPECTION OF THE DEVICE ON (B)(6) 2017, THE LOOPED WIRE APPEARS TO HAVE SEPARATED FROM THE FEEDING TUBE AND WAS NOT PROVIDED WITH THE RETURN. THE PULL WIRE, TWIST LOCKS AND EXTERNAL BOLSTER APPEARS TO BE UNUSED. THE COMMUNICATION RECEIVED ON 6/1/2017 STATES: THE PHYSICIAN FINISHED THE PEG CASE AND THE PHYSICIAN MADE SURE THAT IT WAS FIXED. THEN THE PATIENT WENT TO THE WARD. THAT NIGHT, THE PEG WAS PULLED OUT. CLARIFICATION RECEIVED ON 6/7/2017 STATES: THIS COMPLAINT OCCURRED DURING THE PROCEDURE. WHEN PULLING THROUGH THE TUBING TO ENSURE THAT IT WAS FIXED, THE TUBE WAS PULLED OUT. THEN THEY FINISHED THE PROCEDURE USING ANOTHER PEG SET. CLARIFICATION RECEIVED ON 6/15/2017 STATES: THE INCISION AREA IS APPROXIMATELY 7 TO 8 MM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6665324 ↗