Flow 20 G22638Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002226388), received between May 25, 2018 and Feb 22, 2023 — classified as 3 malfunctions.

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

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2023Material Separation; Material Separation

  DURING A FEEDING TUBE PLACEMENT , THE PHYSICIAN USED A COOK FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL. IT WAS REPORTED [THAT] THE TUBE CAME APART AND THEY HAD TO USE A NEW KIT. THE WIRE CONNECTED TO THE BOLSTER BROKE WHEN THE DOCTOR PULLED IT OUT THROUGH THE INCISION. THERE WERE NO PARTS LEFT INSIDE THE PATIENT. THE DOCTOR CHECKED WHEN THEY TRIED AGAIN WITH THE 2ND PEG KIT. 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 16417725 ↗
• MalfunctionAug 16, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) REMOVAL PROCEDURE, THE PHYSICIAN REMOVED A COOK FLOW20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL. THE INTERNAL BOLSTER POPPED OFF DURING REMOVAL FROM THE PATIENT. THE CASE WAS COMPLETED AT THAT POINT SO NO ADDITIONAL PRODUCT WAS NEEDED, BUT THE PATIENT MAY HAVE GONE FOR A CT AFTERWARDS. ADDITIONAL INFORMATION PROVIDED ON 28-JULY-2021 STATES THAT AS THE PHYSICIAN WAS PULLING THE PEG TUBE FOR REMOVAL THE INTERNAL "MUSHROOM SHAPED" BOLSTER DID NOT COME OUT OF THE ABDOMEN. HE ONLY RETRIEVED THE TUBE IT WAS ATTACHED TO. A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT¿S BODY AND WAS INTENDED TO PASS NATURALLY. THE PATIENT MAY HAVE COMPLETED IMAGING FOLLOWING 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 12328685 ↗
• MalfunctionMay 25, 2018Break; Use of Device Problem; Break; Use of Device Problem

  DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG), THE PHYSICIAN USED A COOK FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL. THE CLINICAL STAFF REPORTED TO DISTRICT MANAGER THAT THE PROCEDURE WAS BEING DONE BY A FELLOW WITH AN ATTENDING PHYSICIAN NEXT TO HIM. THE FELLOW DID NOT INTRODUCE THE TROCAR CORRECTLY. THE SHEATH OF THE NEEDLE [PLASTIC CANNULA] BROKE INSIDE THE PATIENT. THE ATTENDING PHYSICIAN DECIDED NOT TO LOOK FOR THE BROKEN PIECE. HE DECIDED TO SEND THE PATIENT FOR A SURGICAL EVALUATION. ADDITIONAL INFORMATION WAS RECEIVED ON 05/07/2018 DURING A PHONE CONVERSATION WITH THE COOK AREA REPRESENTATIVE: THE GASTROENTEROLOGIST DID NOT WANT TO LOOK FOR THE DEVICE FRAGMENT THAT BROKE OFF IN THE PATIENT'S STOMACH. HE SENT THE PATIENT FOR A SURGICAL EVALUATION TO DETERMINE IF THE FRAGMENT SHOULD BE SURGICALLY REMOVED. SURGERY CHOSE NOT TO INTERVENE AND ALLOWED THE FRAGMENT TO PASS NATURALLY. THE PATIENT REQUIRED AN ADDITIONAL MEDICAL PROCEDURE TO REPLACE THE PEG TUBE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7544237 ↗

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