Cook G22301Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002223018), received between Jun 17, 2016 and Sep 6, 2023 — classified as 2 deaths, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 15, 2025Open, Classified

   Nasal feeding tube packaged without the nasal transfer tube component.

   Z-1298-2026 · Root cause: Employee error · FDA record ↗

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.

• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN NASAL JEJUNAL PLACEMENT PROCEDURE FOR DUODOPA USE, THE PHYSICIAN USED A COOK NASAL JEJUNAL FEEDING TUBE. IT WAS REPORTED [THAT THE] PATIENT WAS SHORT OF BREATH ON RETURN TO WARD POST NJ TUBE INSERTION. CLINICAL REVIEW ATTENDED WITH HOSPITAL MEDICAL OFFICER. CHEST/ABDOMEN X RAY ATTENDED FOR CONFIRMATION OF TUBE PLACEMENT WITH NJ TUBE CONFIRMED IN DUODENUM/JEJUNUM. FURTHER INVESTIGATIONS CONTINUED. PATIENT REMAINED RESTING IN BED WITH SUPPLEMENTAL OXYGEN SUPPLY VIA NASAL PRONGS AND IMPROVED SHORTNESS OF BREATH. DUODOPA CONTINUED UNINTERRUPTED AND WITHOUT CONCERN. NJ TUBE REMAINS INSIDE WITH PATIENT CONTINUING TO BE LESS BREATHLESS AFTER MEDICAL INTERVENTION. NO FURTHER INFORMATION GIVEN. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED OXYGEN SUPPLY VIA NASAL PRONGS. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED SHORTNESS OF BREATH.

  Patient problems: Dyspnea

  MAUDE report 17690062 ↗
• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST PROCEDURE OF A COOK NASAL JEJUNAL FEEDING TUBE PLACEMENT, INFORMATION WAS PROVIDED REGARDING THE PATIENT'S CONDITION. THE PATIENT DEVELOPED PNEUMONIA ON DAY EIGHT (8) OF NJ (NASAL JEJUNAL) TITRATION. THE CAUSE IS UNKNOWN, [WITH] QUESTIONABLE ASPIRATION PNEUMONIA. INTRAVENOUS ANTIBIOTICS, CHEST X-RAY AND FULL BLOOD WORK UP [WERE PERFORMED]. NO MALFUNCTION OF THE DEVICE WAS REPORTED. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. INTRAVENOUS ANTIBIOTICS, CHEST X-RAY AND FULL BLOOD WORK UP WAS PERFORMED. IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Pneumonia

  MAUDE report 8429441 ↗
• MalfunctionSep 29, 2017Break; Break

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK NASAL JEJUNAL FEEDING TUBE (NJFT). A FIVE (5) CM TIP FRACTURE [OCCURRED] ON EXCHANGE OVER A 260 CM STRAIGHT AMPLATZ [COOK WIRE GUIDE]. [IT WAS] DIFFICULT TO THE PASS WIRE. THE WIRE [WENT] THROUGH THE TIP, BUT DUE TO FRICTION, THE TIP FRACTURED. ADDITIONAL INFORMATION WAS RECEIVED ON 09/18/2017: THE TIP OF THE NJFT DETACHED. THE WIRE GUIDE WAS ONLY USED DURING EXCHANGE FOR THE NJFT PLACEMENT.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 6904123 ↗
• DeathSep 13, 2016Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED TO COOK ENDOSCOPY FROM (B)(6). THE PATIENT WAS HOSPITALIZED TO START DUODOPA TREATMENT. ON (B)(6) 2016, THE PATIENT EXPERIENCED RESPIRATORY DISTRESS AND A LUNG GRAPHY WAS PERFORMED AND THE CONSULTATION FROM INFECTION DISEASE DEPARTMENT WAS REQUESTED. AFTER THAT, ASPIRATION PNEUMONIA WAS DIAGNOSED. THE PATIENT WAS INTUBATED DUE TO INCREASING RESPIRATORY DISTRESS AND WAS THEN TRANSFERRED TO ANOTHER HOSPITAL. THE TUBE WAS IN USE WHILE THE PATIENT WAS BEING TRANSFERRED TO ANOTHER HOSPITAL AND THE TUBE WAS THROWN AWAY AT THIS HOSPITAL. THEREFORE, SAMPLE IS NOT AVAILABLE. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED FROM THE COOK DISTRIBUTOR ON 09/09/2016: "IT [COOK NASAL JEJUNAL FEEDING TUBE] WAS PLACED WITHOUT COMPLICATION AND PATIENT WAS TRANSFERRED TO THE NEUROLOGY DEPARTMENT. AFTER ENDOSCOPY UNIT THE DOCTOR ORDERED LUNG X-RAY FOR THE PATIENT. THE PATIENT HAD EMERGENCY BOWEL OPERATION ONE DAY AFTER THIS PROCEDURE THEN RECEIVED TREATMENT IN THE INTENSIVE CARE UNIT (ICU). THE PATIENT PASSED AWAY ONE DAY LATER. THE COMPLICATION WAS NOT RELATED TO THE TUBE."

  Patient problems: Death; Pneumonia; Respiratory Distress

  MAUDE report 5947792 ↗
• InjuryJul 22, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO (B)(4) AFTER AN ENDOSCOPY PROCEDURE, WHERE A COOK NASAL JEJUNAL FEEDING TUBE WAS USED: "THE PATIENT WAS HOSPITALISED FOR TITRATION OF DUODOPA. THE PATIENT EXPERIENCED RESPIRATORY DISTRESS AND DECREASED IN OXYGEN SATURATION LEVEL WHILE INSERTION OF PEG-J [COOK NJFT] TUBE. THEREFORE, THE PROCESS WAS STOPPED AND THE GASTROENTEROLOGIST STATED THAT THERE WAS NO PERFORATION. OXYGEN THERAPY WAS STARTED FOR RESPIRATORY DISTRESS AND ANTIBIOTIC TREATMENT WAS STARTED FOR LUNG INFECTION. ON 7/15/16, COOK RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: ¿ACCORDING TO THE DOCTOR, THE PATIENT WAS TRANSFERRED FROM NEUROLOGY DEPARTMENT FOR THE PLACEMENT OF THE NASAL JEJUNAL FEEDING TUBE. ON ADMISSION TO THE GASTROLOGY DEPARTMENT, THE PATIENT HAD LUNG INFECTION, JUST AS THEY WERE ABOUT TO INTRODUCE THE FEEDING TUBE, THE PATIENT HAD RESPIRATORY DISTRESS AND THE PROCEDURE WAS CANCELLED. THE PATIENT WAS RETURNED TO THE CLINIC AND THEY STARTED TO GIVE THIS PATIENT ANTIBIOTICS. THE DOCTOR REFUSED TO SIGN ANY DOCUMENTS PRESENTED BY US AS COOK [DISTRIBUTOR], AS HE STATED THAT THIS CASE HAD NOTHING TO DO WITH THE JEJUNAL FEEDING TUBE."

  Patient problems: Low Oxygen Saturation; Respiratory Distress

  MAUDE report 5816521 ↗
• DeathJun 17, 2016Kinked; No Apparent Adverse Event; Kinked; No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED TO ABBVIE PHARMACEUTICAL AFTER AN ENDOSCOPY PROCEDURE, WHERE A COOK NASAL JEJUNAL FEEDING TUBE (NJFT) WAS USED: "GASTROENTEROLOGIST TRIED TO PLACE THE NJ [NASAL JEJUNAL] TUBE TO THE PATIENT IN THE ENDOSCOPY UNIT. HE TRIED IT WITH TWO DIFFERENT NJ [NASAL JEJUNAL] TUBES WHICH HAVE THE SAME LOT NUMBERS. BUT THE TUBES KEPT ON FOLDING IN EVERY ATTEMPT. AS A RESULT, THE TUBE COULDN'T BE PLACED. ON (B)(6) 2016 IT IS REPORTED THAT AFTER ATTEMPT OF PLACING NASOJEJUNAL TUBE, CONDITION OF THE PATIENT GOT WORSE, HE WAS TAKEN TO OPERATION AND THEN SPECIAL CARE UNIT AND THE PATIENT DIED ON (B)(6) 2016." ON 06/14/2016, COOK RECEIVED THE FOLLOWING INFORMATION FROM THE (B)(4) DISTRIBUTOR: "WE CONTACTED THE DOCTOR WHO WAS PERFORMING THE PLACEMENT OF THE NJFT. HE WAS VERY SURPRISED THAT A COMPLAINT HAD BEEN MADE. IT SEEMS THAT THE NURSE ALLOCATED BY ABBVIE ISSUED THE COMPLAINT WITHOUT HIS KNOWLEDGE. ACCORDING TO THE DOCTOR WHO PERFORMED THE PROCEDURE, THE DEATH OF THE PATIENT HAD NOTHING TO DO WITH THE FEEDING TUBE, IN ACTUAL FACT. HE MENTIONED THAT IT WAS A COMPLICATION OF THE GASTROSCOPY PROCEDURE." THE MALFUNCTION OF THE COOK NASAL JEJUNAL FEEDING TUBE DID NOT CAUSE OR C

  Patient problems: Death

  MAUDE report 5732972 ↗