PEG 24 G22636Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00827002226364), received between Nov 11, 2016 and Mar 21, 2025 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K920703); they may or may not involve this specific model.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A FEEDING TUBE PLACEMENT, THE PHYSICIAN USED A COOK PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL. IT WAS REPORTED [THAT] THE GASTROSTOMY TUBE RUPTURED, AND A BALLOON-TYPE G-TUBE WAS TEMPORARILY PLACED. CUSTOMER PROVIDED PICTURE THAT SHOWS THE TUBE OUT OF THE PATIENT, AND THE INTERNAL BOLSTER IS DETACHED/TORN OFF. THE INTERNA BOLSTER IS MISSING AND THE LOCATION IS UNKNOWN. IT IS UNKNOWN IF THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE (FURTHER THAN A REPLACEMENT TUBE) DUE TO THIS DETACHED/TORN OFF BOLSTER. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21665412 ↗
• MalfunctionSep 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A FEEDING TUBE PLACEMENT, THE PHYSICIAN USED A COOK PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL. IT WAS REPORTED [THAT] THE DEVICE PLACEMENT WAS COMPLETED IN (B)(6) 2022. THE PATIENT RETURNED TO HOSPITAL IN (B)(6) AND THE DOCTOR FOUND THE DEVICE [INTERNAL DOME TIP] WAS BROKEN IN PATIENT BODY. THE INTERNAL DOME TIP 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

  MAUDE report 15414213 ↗
• MalfunctionMar 30, 2022Material Separation; Material Separation

  DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG), THE PHYSICIAN USED A COOK PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL. IT WAS REPORTED THAT AN ENDOSCOPY WAS DONE UNDER GENERAL ANESTHESIA. THE PEG SITE WAS IDENTIFIED AND DURING THE PROCEDURE, THE WIRE ATTACHED WITH THE PEG TUBE DETACHED FROM THE ORIGINAL TUBE (BROKEN) -[SUBJECT OF REPORT]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. A LAPAROSCOPY WAS PERFORMED TO PLACE A NEW PEG. 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 13951275 ↗
• MalfunctionApr 21, 2021Material Separation; Material Separation

  DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE, THE PHYSICIAN USED A PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET ¿ PULL. THE PHYSICIAN NOTICED THAT THE DILATOR TIP HAD SEPARATED FROM THE FEEDING TUBE. THE DEVICE WAS BROKEN WHEN THE PHYSICIAN DRAGGED IT OUT OF THE PATIENT¿S BODY. THIS OCCURRED WHEN THE PHYSICIAN WAS DRAGGING THE DEVICE OUT OF THE PATIENT'S ABDOMINAL WALL. THE USER CHANGED TO A NEW REPLACEMENT DEVICE TO COMPLETE THE PLACEMENT. IT WAS REPORTED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY AND THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES. HOWEVER, IT IS ASSUMED THAT THE SECTION OF THE DEVICE THAT BROKE WAS REMOVED. 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 11704488 ↗
• MalfunctionDec 10, 2020Break; Break

  DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG), THE PHYSICIAN USED A PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET ¿ PULL. THE WIRE GUIDE WAS INTRODUCED WITH OUT COMPLICATION. THE WIRE GUIDE WAS EXTRACTED THROUGH THE ORAL CAVITY USING THE POLYPECTOMY HANDLE PROVIDED. THE PHYSICIAN PROCEEDED TO REMOVE THE GASTROSTOMY TUBE FROM THE PLASTIC CONTAINER AND CRIMP IT WITH THE GUIDE, HOWEVER, AT THE INITIAL INTRODUCTION, THE BUTTON [BOLSTER] DETACHED. THE PROCEDURE IS SUSPENDED AND A NEW PROBE IS PLACED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE INITIAL REPORTED INDICATED THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. HOWEVER, IT IS UNCLEAR BASED ON INFORMATION PROVIDED IF THE SECTION OF THE DEVICE DETACHED PRIOR TO BEING INTRODUCED IN THE PATENT OR AFTER IT HAD BEEN INSERTED AND HAD TO BE REMOVED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10985325 ↗
• InjuryDec 2, 2020Break; Break

  DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG), THE PHYSICIAN USED A COOK PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL AND STATED THAT 3 DAYS AFTER PLACEMENT, PATIENT HAD SOME DIFFICULTIES INCLUDING FOOD LEAKAGE TO THE EXTERIOR AND HE FOUND PEG TUBE BROKEN. AFTER THAT, HE RETIRED [RETRIEVED] THE BROKEN PARTS AND REPLACED THE TUBE FOR A NEW ONE USING THE SAME OSTOMY THAT WAS USED ORIGINALLY. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED FROM A LETTER FROM THE PHYSICIAN. I HAVE BEEN TREATING PATIENT, (B)(6) YEARS OLD, FOR A CARCINOMA IN HER LARYNX. SHE IS RADIOTHERAPY RECURRENT. ON (B)(6) 2020 SHE WAS SUBJECTED TO SURGERY IN (B)(6) HOSPITAL (B)(6). THE PROCEDURE STARTED WITH AN ENDOSCOPIC GASTROSTOMY WHICH CONCLUDED WITHOUT INCIDENTS. THEN WE PROCEEDED WITH TOTAL LARYNGECTOMY WITH SELECTIVE BILATERAL DISSECTION OF THE NECK WITHOUT COMPLICATIONS. SHE STARTED HER DIET THROUGH THE CATHETER ON (B)(6) 2020, WITHOUT ANY PROBLEMS. AT 06:00 HRS. OF (B)(6) WE STARTED HAVING DIFFICULTIES FEEDING HER THROUGH THE PROBE, WITH LEAKING TO THE EXTERIOR AND PAIN, AFTER THAT THE CATHETER WAS SPONTANEOUSLY SELF-EJECTED. THE CT SHOWED THAT THE INTERNAL DOME WAS IN THE GASTRIC WALL. THAT

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 10936411 ↗
• InjuryNov 13, 2020Break; Break

  AFTER A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) ,WHERE THE PHYSICIAN USED A PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET ¿ PULL, THERE WAS DISLODGEMENT OF THE TULIP TIP [BOLSTER]. PER ADDITIONAL INFORMATION RECEIVED ON 26 OCT 2020: PEG-24-PULL PLACED ON (B)(6) 2020. ON (B)(6) 2020, PATIENT CAME TO THE HOSPITAL COMPLAINING OF DISLODGEMENT OF TUBE; THEN THE DOCTOR SAW THE MISSING TULIP TIP (BUMPERS) ON THE TUBE. THEN IMMEDIATELY TOOK X-RAY AND FOUND THE TUBE IN INTESTINES AND TOOK NEEDED STEPS TO REMOVE THE TUBE (BUMPER). THE BOLSTER OF THE DEVICE DETACHED INSIDE THE PATIENT¿S BODY. THE PATIENT UNDERWENT COLONOSCOPY TO REMOVE THE BOLSTER. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10836613 ↗
• MalfunctionFeb 1, 2019Device Contamination with Chemical or Other Material

  STERILITY ISSUE - STAFF NOTED A HAIR IN THE 'STERILE' SEALED PEG KIT. REMOVED FROM INVENTORY & RETAINED. NOT USED ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8296480 ↗
• MalfunctionMay 4, 2018Break; Use of Device Problem; Break; Use of Device Problem

  THE FOLLOWING INFORMATION WAS PROVIDED TO COOK BY THE USER REGARDING A COOK PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL: THE PHYSICIAN WAS LOOKING AFTER ANOTHER PHYSICIAN'S PATIENT. UPON THE THIRD DAY OF HANDLING THE PATIENT, DURING ROUNDS, SHE CHECKED THE STOMA SITE OF THE PEG AND NOTICED THAT THE PEG TUBE [APPEARED] "CUT" WHILE PALPATING THE SITE. SHE DECIDED TO INSERT A NEW PEG-24-PULL-S AND THE PATIENT HAD AN X-RAY AND SAW THAT THE INNER BOLSTER WAS LEFT INSIDE THE PATIENT'S BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 7488615 ↗
• MalfunctionJun 8, 2017Material Separation; Material Separation

  THE FOLLOWING WAS INITIALLY PROVIDED ON 6/8/2017: "DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET (PULL). DURING THE PROCESS OF PULLING THE FEEDING TUBE OUTSIDE THE STOMA, THE FEEDING TUBE'S LOOP KNOTTED TO THE LOOP INSERTION WIRE WAS DETACHED FROM THE FEEDING TUBE. OBSERVING THE LOOP THAT WAS DETACHED FROM THE TUBE, IT WAS CLEANING [CLEANLY] DETACHED FROM THE TUBE WITHOUT EXERTING A LOT OF EFFORT DURING THE PULLING TECHNIQUE. THE PEG WAS INSERTED BUT THE METALLIC LOOP CONNECTED TO GUIDE WIRE (BLUE) WAS DETACHED DURING A PULL THROUGH PROCESS. IT STATES THAT A SECTION DID REMAIN IN THE PATIENT'S BODY AND THAT IT WAS RETRIEVED WITH THE ENDOSCOPE AND SNARE. THE COMMUNICATION RECEIVED ON 5/16/2017 STATES: WE INITIALLY COMMITTED TO REPLACE TWO (2) UNITS. ONE THAT GOT DETACHED AND ONE THAT WAS OPENED, BUT THE PATIENT'S RELATIVE DECIDED TO TRANSFER TO A DIFFERENT HOSPITAL AND USE A DIFFERENT BRAND THUS IT WAS NOT USED." THE FOLLOWING CLARIFICATION WAS RECEIVED ON 7/4/2017: THERE WERE NO SECTIONS OF THE DEVICE THAT DETACHED OR BECAME FREE INSIDE OF THE PATIENT, THERE WAS NO NEED TO USE A SNARE TO RETRIEVE THE DEVICE. THE

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

  MAUDE report 6621970 ↗
• InjuryNov 11, 2016Device Reprocessing Problem; Contamination; Improper or Incorrect Procedure or Method; Device Reprocessing Problem; Contamination; Improper or Incorrect Procedure or Method

  AFTER THE PLACEMENT OF A COOK PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL THE FOLLOWING WAS PROVIDED TO COOK FROM THE PATIENT'S SPOUSE ON 10/03/2016: "OUR PATIENT [PATIENT'S WIFE] HAD BEEN OPERATED FOR PEG IN THE MONTH OF (B)(6) 2016 [THE TUBE WAS IMPLANTED IN (B)(6) 2016] AND THE TUBE IS OF COOK MEDICAL I.E. PEG 24. EVEN THOUGH WE ARE CLEANING THE TUBE ON REGULAR BASIS STILL IT IS NOT GETTING 100% CLEAN AND GETTING CONTAMINATED. DUE TO WHICH THE HEALTH OF THE PATIENT IS GETTING AFFECTED. ACCORDING TO THE DOCTORS THERE IS A PROBLEM IN THE TUBE DUE TO WHICH THIS IS HAPPENING AGAIN AND AGAIN. WE HENCE REQUEST YOU TO HELP US WITH THE REPLACEMENT OF THE TUBE ALONG WITH THE APPROPRIATE CLEANING INSTRUMENT WITHOUT ANY CHARGES AS THIS THE TUBE IS A DEFECTIVE WHICH WAS GIVEN TO US AND DUE TO WHICH WE ARE FACING SO MANY PROBLEM AND THE BIGGEST RISK IS THAT OF PATIENT'S HEALTH [THERE IS NOT A SPECIAL CLEANING INSTRUMENT FOR THIS DEVICE; DEVICE IS CLEANED BY FLUSHING WITH 30-50 CC OF WATER]." THIS COMPLAINT DID NOT INCLUDE REPORTABLE INFORMATION AT THAT TIME. THE FOLLOWING WAS PROVIDED FROM THE PATIENT'S SPOUSE PER A COOK COMPLAINT COMMUNICATION FORM RECEIVED ON 10/17/2016: "THE PAT

  Patient problems: Aspiration/Inhalation; No Consequences Or Impact To Patient; Unspecified Infection

  MAUDE report 6097106 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K920703. One submission often covers many models, so check the product and lot details in each record.

• Z-1910-2009 · Jul 24, 2009 · Terminated
  Jejunal Feeding Set, Product Order number FLOWJ-9-20. This device is used for percutaneous endoscopic placement to provide enteral nutrition to patients requiring nutritional supp