Flexor G13212Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002132122), received between May 26, 2017 and Jun 25, 2018 — classified as 2 injuries.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, A FEMALE PATIENT IN HER "EARLY 60'S" WITH A NON-HEALING, LEFT FOOT, VASCULAR ULCER, UNDERWENT A STENT PLACEMENT (SITE NOT SPECIFIED) ON (B)(6) 2018 IN AN OUTPATIENT FACILITY. MULTIPLE COOK PRODUCTS WERE USED. ON (B)(6) 2018, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A FEVER (TEMPERATURE UNKNOWN TO COMPLAINANT) AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS DIAGNOSED WITH SEPSIS WHICH WAS TREATED WITH "FLUIDS AND IV ANTIBIOTICS" AND IS "DOING FINE". REPORTEDLY, LAB RESULTS INDICATE A STRAIN OF STREP WAS IDENTIFIED, HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED. PER THE COMPLAINANT: "SEVERAL COOK PRODUCTS WERE INVOLVED WITH ORIGINAL PROCEDURE, UNKNOWN AND NOT ALLEGED AT THIS TIME IF ANY OF THEM MAY HAVE CONTRIBUTED TO THIS." A SECTION OF THE DEVICES DID NOT REMAIN IN THE PATIENT'S ANATOMY. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND RELEVANT MEDICAL HISTORY HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME. PLEASE REFERENCE ADDITIONAL MEDWATCH NUMBERS REGARDING ALL COOK PRODUCTS IN USE DURING THE PROCEDURE: CID-20-30-NG (1820334-2018-01470), KCFW-5.0-38-RB (1820334-2018-01613) THIS REPORT, KCFW-6.0-18/38-45-RB-ANL0-HC (182033

  Patient problems: Sepsis

  MAUDE report 7634190 ↗
• InjuryMay 26, 2017Break; Break

  IT WAS REPORTED THAT CONTRALATERAL ACCESS WAS GAINED FOR A LOWER LEG ANGIOGRAM. AT THE END OF THE PROCEDURE, THE USER ATTEMPTED TO REMOVE THE SHEATH TO CLOSE THE RIGHT COMMON FEMORAL VESSEL. THE DILATOR WAS PLACED BACK IN THE SHEATH AND THE SHEATH FRACTURED; A FRAGMENT REMAINED IN THE PATIENT. THE FRAGMENT WAS RETRIEVED USING A BALLOON. 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 EXPERIENCED ADDITIONAL PAIN DUE TO THIS OCCURRENCE.

  Patient problems: Intraoperative Pain

  MAUDE report 6593812 ↗