Flex 10260Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850037498413), received between Jul 29, 2025 and Jul 29, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 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.

• MalfunctionJul 29, 2025Difficult to Remove; Device-Device Incompatibility; Patient Device Interaction Problem; Difficult to Remove; Device-Device Incompatibility; Patient Device Interaction Problem

  CUSTOMER REPORTED IT WAS DIFFICULT TO REMOVE THE DEVICE. CUSTOMER WENT TO THE EMERGENCY ROOM TO HAVE THE DEVICE REMOVED BY A MEDICAL PROFESSIONAL. IT WAS NOTED THAT FORCEPS WERE USED TO REMOVE THE DEVICE. DOCTOR STATED THE DISC HAD CREATED A SUCTION TO CUSTOMERS CERVIX. IN THE PROCESS OF REMOVAL, THE CUSTOMER'S IUD (INTRAUTERINE DEVICE) WAS ACCIDENTALLY REMOVED FROM THE SUCTION. CUSTOMER EXPERIENCED PAIN. THE INSTRUCTIONS FOR USE THAT ARE PROVIDED IN THE PACKAGING WITH THE DEVICE STATE "CONSULT YOUR DOCTOR IF YOU ARE USING AN INTRAUTERINE DEVICE (IUD). WHILE UNCOMMON, THERE IS A RISK OF DISLODGING, DISPLACING, OR REMOVING THE IUD BY PULLING ON THE IUD STRING WHEN REMOVING FLEX DISC." 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: Pain

  MAUDE report 22644568 ↗