Flow 20 G56403Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002564039), received between Feb 23, 2017 and May 20, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Difficult to Advance” (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.

• InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED TO COOK BY THE USER: THIS WAS A NEW PEG PLACEMENT. THERE WERE NO ISSUES DURING THE PLACEMENT [OF THE DEVICE]. THE PLACEMENT WAS VERIFIED ENDOSCOPICALLY, THE BUMPER WAS APPROPRIATELY NOTED IN RELATION TO THE SKIN. THE PEG SITE BECAME INFECTED PRIOR TO BEING UTILIZED FOR FEEDINGS, AS IT WAS PLACED FOR USE POST CHEMO AND RADIATION FOR A NECK/THROAT CANCER. THE PATIENT RETURNED TO THE GASTRO-INTESTINAL (GI) LAB WITHIN SEVEN (7) DAYS OF THE INITIAL PEG PLACEMENT AS A RESULT OF BEING SEEN BY THE ONCOLOGIST. ADDITIONAL INFORMATION WAS RECEIVED ON 01-MAY-2019: THE DEVICE WAS PLACED (B)(6) 2019 [WITH] NO ISSUES. [THE PATIENT] RETURNED (B)(6) 2019 [WITH AN] INFECTION [THAT WAS] TREATED WITH ORAL ANTIBIOTICS WITH SUCCESS. SEVERAL ATTEMPTS WERE MADE IN AN ATTEMPT TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT IMPACT AND PRODUCT USAGE. IT IS UNKNOWN IF A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT REQUIRED ANTIBIOTICS DUE TO THIS OCCURRENCE. BECAUSE THE COMPLAINANT STATED THAT THE INFECTION WAS TREATED WITH SUCCESS, WE CAN CONCLUDE THAT THIS INFORMATION DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: Unspecified Infection

  MAUDE report 8625127 ↗
• InjuryMay 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED TO COOK BY THE USER: AN UNKNOWN PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WAS PLACED; THE PATIENT CAME BACK WITH AN INFECTION AND IRRITATION AT THE INSERTION SITE. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE PEG WAS REMOVED AND NO REPLACEMENT DEVICE WAS USED. [THE INSERTION SITE WAS] LEFT TO CLOSE ON ITS OWN. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2019: THE DEVICE WAS A FLOW-20-PULL-SSK-S-T. ADDITIONAL INFORMATION PROVIDED BY CUSTOMER ON (B)(6) 2019: THIS WAS A NEW PEG PLACEMENT. THERE WERE NO ISSUES DURING THE PLACEMENT [OF THE DEVICE]. THE PLACEMENT WAS VERIFIED ENDOSCOPICALLY, THE BUMPER WAS APPROPRIATELY NOTED IN RELATION TO THE SKIN. THE PEG SITE BECAME INFECTED PRIOR TO BEING UTILIZED FOR FEEDINGS, AS IT WAS PLACED FOR USE POST CHEMO AND RADIATION FOR NECK/THROAT CANCER. THE PATIENT RETURNED TO THE GASTRO-INTESTINAL (GI) LAB WITHIN SEVEN (7) DAYS OF THE INITIAL PEG PLACEMENT AS A RESULT OF BEING SEEN BY THE ONCOLOGIST. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019: THE DEVICE WAS PLACED (B)(6) 2019 [WITH] NO ISSUES. [THE PATIENT] RETURNED (B)(6) 2019 AND WAS ADMITTED TO THE HOSPITAL FOR A PEG SITE INFECTION. THE PEG WAS RE

  Patient problems: Unspecified Infection

  MAUDE report 8588981 ↗
• InjuryFeb 23, 2017Difficult to Advance; Difficult to Advance

  DURING A PROCEDURE, THE PHYSICIAN USED A FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL. AS REPORTED FROM MEDWATCH MW5067337: "INVOLVES THE PORTION OF THE PEG TUBE (THE INTRODUCER) [SILICONE FEEDING TUB]. THE PHYSICIAN HAD DIFFICULTY THREADING A NYLON THROUGH THE INTRODUCER [SILICONE FEEDING TUBE], RESULTING IN ABORTING THE PROCEDURE. MAY HAVE BEEN SECONDARY TO USER ERROR, BUT UNSURE. MANAGER OF ENDOSCOPY NOTIFIED MANUFACTURER." THIS EVENT WAS NOT REPORTED TO THE MANUFACTURER FROM THE USER FACILITY, AS INDICATED IN THE MEDWATCH.

  Patient problems: No Information

  MAUDE report 6354799 ↗

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