Falope Ring 005280-901Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821925032996), received between Feb 2, 2021 and Jul 6, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2022Use of Device Problem; Use of Device Problem

  THE 005280-901 FALOPE RING APPLICATOR IS NOT DEPLOYING THE BAND PROPERLY. THE CUSTOMER HAS LOST BANDS INSIDE THE PATIENT AND WILL NE ED TO RETRIEVE THEM.

  Patient problems: Foreign Body In Patient

  MAUDE report 14940437 ↗
• InjuryMar 25, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  IT IS REPORTED DURING A LAPAROSCOPIC TUBAL LIGATION USING A FBK DUAL WITH TROCAR, THE APPLICATOR BECAME STUCK ON THE FALLOPIAN TUBE OF THE PATIENT. THE PHYSICIAN HAD TO MAKE A SMALL INCISION TO INTRODUCE AN ADDITIONAL PORT FOR PASSAGE OF GRASPERS TO REMOVE THE ENTRAPPED DEVICE FROM THE FALLOPIAN TUBE. NO ADDITIONAL CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11568353 ↗
• MalfunctionFeb 2, 2021Labelling, Instructions for Use or Training Problem; No Apparent Adverse Event; Labelling, Instructions for Use or Training Problem; No Apparent Adverse Event

  IT IS REPORTED A FALLOPE RING BAND WAS IMPLANTED IN A PATIENT FOUR DAYS PAST IT'S LABELED EXPIRATION DATE. THERE WAS NO REPORTED INJURY OR INFECTION DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11266635 ↗

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