Flex Cup and Flex Disc Flex Discovery Kit Full FitRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00851906007255), received between Sep 6, 2023 and Jun 17, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 reports).

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 18, 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.

• MalfunctionJun 17, 2025Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER REPORTED GOING TO THEIR DOCTOR FOR ASSISTANCE WITH REMOVAL OF A FLEX REUSABLE DISC. THEY STATES THAT THE DOCTOR SAID THERE WAS NO WAY TO REMOVE IT WITHOUT MEDICAL INTERVENTION. FLEX MADE THREE ATTEMPTS TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION. CUSTOMER DID NOT RESPOND. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSE OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22248411 ↗
• MalfunctionJun 11, 2025Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER REPORTED GOING TO THE EMERGENCY ROOM FOR ASSISTANCE WITH REMOVAL OF A FLEX REUSABLE DISC. THEY STATED THAT THE DOCTOR SAID THERE WAS NO WAY TO REMOVE IT WITHOUT MEDICAL INTERVENTION. FLEX MADE THREE ATTEMPTS TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION. CUSTOMER DID NOT RESPOND. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186552 ↗
• MalfunctionJan 13, 2025Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  CUSTOMER REPORTED THAT THE PULL-TAB BROKE OFF THEIR SIZE 2 FLEX CUP DURING ATTEMPTED REMOVAL. AS A RESULT, THE CUSTOMER WAS UNABLE TO REMOVE THE CUP THEMSELVES AND WAS SEEN BY A DOCTOR FOR ASSISTANCE WITH REMOVAL. THE CUSTOMER STATED THAT THE DOCTOR DID USE TOOLS TO ASSIST WITH REMOVAL, BUT DID NOT SPECIFY WHICH TOOLS WERE USED. VISIT/TREATMENT NOTES DID NOT SPECIFY WHICH TOOLS WERE USED AND STATED THAT THE FLEX CUP WAS REMOVED IN ONE PIECE. THE CUP HAD BEEN INSERTED FOR APPROXIMATELY 18 HOURS AT TIME OF REMOVAL. THE CUSTOMER REPORTED EXPERIENCING NO ADVERSE SYMPTOMS UPON INSERTION, DURING USE, AND FOLLOWING THE MEDICALLY ASSISTED PRODUCT REMOVAL AND WAS NOT PRESCRIBED ANY MEDICATION. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21146385 ↗
• MalfunctionSep 6, 2023Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER REACHED OUT TO THE COMPANY'S CUSTOMER EXPERIENCE TEAM VIA EMAIL AND STATED THAT THEY USED A SIZE 1 FLEX CUP FOR A FEW MONTHS THEN SWITCHED TO THE SIZE 2 FLEX CUP AND USED IT FOR APPROXIMATELY SIX MONTHS WITHOUT INCIDENT. THE CUSTOMER STATED THAT WHILE WEARING THE CUP OVERNIGHT, IT SHIFTED AND THEY WERE UNABLE TO REMOVE IT. THE CUSTOMER WENT TO THE EMERGENCY ROOM FOR ASSISTANCE WITH REMOVAL OF THE CUP. THE CUSTOMER DID NOT INDICATE HOW LONG THE DEVICE HAD BEEN IN PLACE PRIOR TO REMOVAL. THE CUSTOMER INDICATED THAT TWO PHYSICIANS WORKED TO REMOVE THE DEVICE AND HAD A DIFFICULT TIME. THE CUSTOMER STATED THAT ONE OF THE PHYSICIANS INFORMED THE CUSTOMER THAT THE CUP HAD SHIFTED TO "THE TOP OF MY CERVIX". NO ADVERSE SYMPTOMS WERE REPORTED BY EITHER THE CUSTOMER OR THE PHYSICIANS DURING OR AFTER REMOVAL OF THE DEVICE. THE CUSTOMER WAS ADVISED TO DISCONTINUE THEIR USE OF THE DEVICE. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695816 ↗