Falope-Ring 006889-901Recalls & reported problems
Gyrus ACMI, LLC · DISPOSABLE FALOPE-RING BAND Applicator Kit · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925032989), received between Mar 5, 2020 and Mar 5, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Misfire” (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
Device problems
- Misfire1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2020Misfire; Misfire
THE SERVICE CENTER RECEIVED A REPORT OF A DISPOSABLE FALOPE-RING BAND KIT (MODEL 006889-901), LOT NUMBER MK735611, THAT MALFUNCTIONED DURING A PROCEDURE. THE FALOPE-RING BAND KIT WAS INSPECTED PRIOR TO THE PROCEDURE AND NO ANOMALIES WERE OBSERVED. IT WAS REPORTED A PHYSICIAN USED THE FALOPE-RING BAND DURING A THERAPEUTIC HYSTEROSCOPIC OCCLUSION OF FALLOPIAN TUBES, AND THE DEVICE DID NOT DEPLOY CORRECTLY/MISFIRED. THE PHYSICIAN OPENED AND USED A SECOND FALOPE-RING BAND KIT TO COMPLETE THE PROCEDURE. IT WAS REPORTED THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9793835 ↗
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 · TerminatedGyrus 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 · TerminatedGyrus 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 · TerminatedGyrus 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
Other Device, Occlusion, Tubal, Contraceptive devices
- FALOPE-RING FRB-30Gyrus ACMI, LLC · Device, Occlusion, Tubal, Contraceptive4 reports
- Filshie® Clips AVM-851Femcare Limited · Device, Occlusion, Tubal, Contraceptive4 reports
- Falope Ring 005280-901Gyrus ACMI, LLC · Device, Occlusion, Tubal, Contraceptive3 reports
- Hulka Clips 4986.90Richard Wolf Medical Instruments Corp. · Device, Occlusion, Tubal, Contraceptive3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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