Flow 20 G31543Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002315433), received between Apr 13, 2017 and Apr 13, 2017 — classified as 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2017Break; Break

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED TWO (2) COOK FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SETS - PUSH. THE WIRE GUIDE IN THE KIT WAS NOT COMING OUT OF THE RACE TRACK PORT. WHEN THEY TRIED TO OPEN THE WIRE GUIDE, THE WIRE GUIDE BROKE. THIS OCCURRED WITH TWO DEVICES FROM THE SAME LOT DURING THIS PROCEDURE. THE DEVICES DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS ABORTED DUE TO THESE DEFECTIVE PRODUCTS. THE PATIENT WILL NOW REQUIRE ANOTHER PROCEDURE FOR THE PEG PLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6489971 ↗

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