Flow 20 G22761Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002227613), received between Jan 27, 2017 and Nov 8, 2019 — classified as 3 injuries.

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

• InjuryNov 8, 2019Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) INSERTION PROCEDURE, THE PHYSICIAN USED A COOK FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL. THE TUBE WAS PARTIALLY CUT BETWEEN THE INTERNAL BUMPER AND 2 CM MARKING, RESULTING IN PERITONITIS. THERE WAS INCREASED INTRAPERITONEAL GAS AND FLUID, SO EMERGENCY EXPLORATORY LAPAROTOMY WAS PERFORMED. THE FOLLOWING CLARIFICATION WAS RECEIVED ON 29 OCT 2019 FROM THE USER FACILITY: IT IS UNCLEAR IF THE TUBE BROKE OR WAS CUT. THE TUBE WAS VISUALLY INTACT WHEN PLACED AND WAS FOUND AS PER THE PICTURES AT A LAPAROTOMY SEVERAL DAYS LATER. THE VIEW OF THE CLINICAL STAFF IS THAT IT WAS CUT AS THE BREAK IS VERY CLEAN AND THERE APPEARS TO BE AN ADDITIONAL PARTIAL CUT AT APPROX. THE 3 CM MARK. IT IS UNCLEAR WHO WOULD HAVE DONE THAT (PATIENT, RELATIVE OR STAFF MEMBER), BUT OUR VIEW IS THAT IT WOULD BE UNLIKELY TO BE ACCIDENTAL. THE PATIENT DEVELOPED SYMPTOMS WITHIN 24 HOURS AFTER INSERTION AND UNDERWENT A COMPUTERIZED TOMOGRAPHY (CT) SCAN WHICH DEMONSTRATED THAT THE BUMPER WAS IN THE STOMACH, THE SYMPTOMS WORSENED AND A SECOND CT SCAN THE NEXT DAY SHOWED INCREASING INTRAPERITONEAL GAS AND FLUID COLLECTION. THAT SCAN PROMPTED THE LAPAROTOMY AT

  Patient problems: Unspecified Infection

  MAUDE report 9296371 ↗
• InjuryAug 24, 2018Break; Break

  THE FOLLOWING INFORMATION WAS PROVIDED TO COOK BY THE USER REGARDING A COOK FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL. A PEG FLOW-20 WAS PLACED (B)(6) 2018. THE PATIENT CAME BACK (B)(6) 2018 BECAUSE THE BUMPER CAME OFF. IT WAS IN THE SMALL INTESTINE [NOTED] AFTER THE X-RAY. AFTER TWO (2) DAYS THE PATIENT PASSED IT OUT THROUGH THE RECTUM. THE INNER 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 HAD TO BE ADMITTED DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7813724 ↗
• InjuryJan 27, 2017Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  THE FOLLOWING INFORMATION WAS REPORTED TO THE FDA ON JAN 27, 2017: "DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE, THE PHYSICIAN USED A COOK FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL DEVICE. DURING THE PROCEDURE, WHILE THE SURGEON WAS PULLING THE PEG TUBE THROUGH THE STOMACH WALL AND ABDOMINAL WALL, THE INTERNAL BUMPER [BOLSTER] OF THE PEG TUBE WAS TORN AND SEPARATED FROM THE TUBE. CLARIFICATION RECEIVED JAN 25, 2017 STATED: THE BOLSTER SUDDENLY DETACHED FROM THE FEEDING TUBE DURING THE PROCEDURE (PULL TECHNIQUE). THE DOCTOR WENT TO SEE BY ENDOSCOPE AND FOUND THE BOLSTER STAYED IN THE STOMACH. THE DOCTOR TRIED TO RETRIEVE THE BOLSTER BY USING A SNARE, BUT UNFORTUNATELY THE SITUATION OF THE STOMACH PERFORATION QUICKLY CAUSED LOTS OF AIR INSIDE STOMACH FROM THE PROCEDURE SO THE RETRIEVAL WAS NOT SUCCESSFUL. THE DOCTOR HAD TO REPAIR THE PERFORATION QUICKLY AND IT WAS NOT AN OPTION TO DO BY ENDOSCOPIC TECHNIQUE. THE DOCTOR DID "LAP EXPLORE" TO SAVE THE PATIENT FIRST TO REPAIR THE HOLE OF PERFORATION AND REMOVED THE BOLSTER AS WELL." THE FOLLOWING CLARIFICATION RECEIVED ON FEB 1, 2017 STATED: THE PHYSICIAN IS NOT REFERRING TO THE INCISION AS A PERFORATION. TH

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

  MAUDE report 6284064 ↗

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