FALOPE-RING FRB-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821925032972), received between Feb 9, 2021 and Sep 27, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Expiration Date Error” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (P870076); 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.

• MalfunctionSep 27, 2022Misfire; Misfire

  THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS RECEIVED FROM THE CUSTOMER: THE PROCEDURE BEING PERFORMED WAS A LAPAROSCOPIC ATTEMPTED BILATERAL TUBAL LIGATION WITH FALOPE-RINGS. THE PATIENT WAS DISCHARGED AFTER THE PROCEDURE. THERE IS NO PLAN TO RETRIEVE THE FALOPE-RING FROM THE PATIENT'S ABDOMEN. THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE. THREE PACKAGES OF FALOPE-RINGS WERE OPENED DURING THE PROCEDURE (LOT KR973924, 324909.MAH 417884).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15493547 ↗
• MalfunctionAug 23, 2022Expiration Date Error; Expiration Date Error

  THE CUSTOMER REPORTED TO OLYMPUS, THE F-R BANDS,30 PROCEDURE WAS INSTALLED BY THE PHYSICIAN AFTER THE EXPIRATION DATE ADVISED. IT WAS REPORTED THAT THE PHYSICIAN IS REPLACING THE DEVICE IN QUESTION WITH A DEVICE THAT THE EXPIRATION DATE HAS NOT EXPIRED. THE CUSTOMER WAS ADVISED THAT AFTER THE EXPIRATION DATE OF A PRODUCT EXPIRES, PACKAGE DEGRADATION COULD OCCUR EFFECTING THE STERILITY OF THE DEVICE AND DEVICE SHOULD NOT BE USED ON A PATIENT. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15278936 ↗
• MalfunctionAug 3, 2022Expiration Date Error; Expiration Date Error

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, THE DEVICE (FALLOPIAN RING) PLACED IN THE PATIENT HAD EXPIRED 12 DAYS PRIOR TO THE PROCEDURE. THERE WAS NO ISSUE IN THE COMPLETION OF THE PROCEDURE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15155450 ↗
• MalfunctionFeb 9, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE SERVICE CENTER WAS INFORMED THAT AN EXPIRED FALOPE BAND WAS IMPLANTED INTO A PATIENT. THE FACILITY WILL CONTINUE TO MONITOR THE PATIENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 11302319 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P870076. One submission often covers many models, so check the product and lot details in each record.

• Z-0419-2015 · Oct 21, 2014 · Terminated
  Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Ban
• Z-2269-2014 · Jul 8, 2014 · Terminated
  Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device
• Z-1196-2014 · Feb 19, 2014 · Terminated
  Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring