Flow 20 G22637Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002226371), received between Dec 23, 2016 and Jul 29, 2022 — classified as 1 injury, 3 malfunctions.

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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2022Fracture; Fracture

  DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG), THE PHYSICIAN USED A COOK FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PUSH DEVICE. IT WAS REPORTED THAT THE PROBLEM OCCURRED DURING PLACEMENT ABOUT HALF WAY THROUGH THE PROCEDURE. WHEN THEY [PHYSICIAN] SNARED THE WIRE, THE WIRE GOT A KINK IN IT. WHEN THEY WENT TO PULL IT, THE KINK CAUSED THE GUIDE WIRE TO FRAY. THEY HAD TO STRUGGLE TO GET THE PEG PLACED WITH THE GUIDE WIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE RETUNED AND DURING THE EVALUATION IT WAS NOTED THAT THE DISTAL END OF THE WIRE GUIDE WAS FULLY SEVERED AT APPROXIMATELY 1.5 CM - 1.6 CM AND 36.8 CM FROM THE DISTAL END. [SUBJECT OF REPORT] 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 15133902 ↗
• MalfunctionNov 30, 2021Difficult or Delayed Positioning; Positioning Failure; Difficult or Delayed Positioning; Positioning Failure

  DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG), THE PHYSICIAN USED TWO (2) COOK FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PUSH DEVICES. IT WAS REPORTED THAT THERE WAS A "DEFORMITY OF THE CATHETER DURING INSERTION AT THE MOMENT OF PASSAGE THROUGH THE STOMACH. ANOTHER DEVICE WAS USED WITH THE SAME CHARACTERISTICS WITH THE SAME RESULT. THE PROCEDURE CANNOT BE CARRIED OUT." IT WAS ALSO REPORTED THAT THERE WAS NO INJURY TO THE PATIENT. THIS IS INTERPRETED TO MEAN THAT THERE WAS DIFFICULTY PASSING THE TUBE THROUGH THE INCISION SITE DURING PLACEMENT. 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 12898296 ↗
• InjuryJun 19, 2018Break; Break

  DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG), THE PHYSICIAN USED A COOK FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PUSH. IN THE PLACEMENT OF THE GASTROSTOMY TUBE, AT THE MOMENT OF THE TRACTION TO EXTERNALIZE [THROUGH] THE ABDOMINAL WALL, THE GUIDE [WIRE] FRAYED. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED ON 25-MAY-2018: A PORTION OF THE WIRE GUIDE DETACHED INSIDE THE STOMACH AND WAS REMOVED WITH FORCEPS, USED FOR FOREIGN BODY RETRIEVAL. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE DETACHED PORTION OF THE WIRE GUIDE WAS REMOVED WITH FORCEPS DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORT, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7615135 ↗
• MalfunctionDec 23, 2016Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE REMOVAL PROCEDURE, THE PHYSICIAN WAS REMOVING A FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PUSH DEVICE. UPON PULLING ON THE DEVICE (PER USUAL) OVER A STIFF GUIDE WIRE, THE BUMPER [BOLSTER] SEPARATED FROM THE TUBE AND REMAINS IN THE PATIENT. THIS WAS A PLANNED REMOVAL AND REPLACEMENT. IT WAS CONFIRMED THAT THE COMPLAINT DEVICE WAS IN PLACE FOR SIX (6) MONTHS.

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

  MAUDE report 6202464 ↗

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