Filshie® Clips AVM-851Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05055515602121), received between Jan 4, 2017 and Jan 10, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2020Difficult to Open or Close

  DURING TUBAL LIGATION, THE FILSHIE CLIP APPLICATOR WAS INSERTED AND FILSHIE CLIP WAS ATTEMPTED TO BE DEPLOYED, BUT IT WOULD NOT LOCK ON THE TUBE. THREE OTHER FILSHIE CLIPS WERE TRIED AND NONE OF THEM WOULD LOCK ON THE TUBE. SURGEON ATTEMPTED TO CLOSE AND ENGAGE THE CLIPS OUTSIDE THE BODY, AND THEY WOULD NOT ENGAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9574379 ↗
• MalfunctionJan 31, 2019Positioning Problem

  PHYSICIAN WAS GOING TO USE THE FILSHIE CLIPS TO PERFORM A BILATERAL TUBAL LIGATION. ONE OF FILSHIE CLIPS WOULD NOT CLASP. PHYSICIAN HAD TO INSTEAD PERFORM A STANDARD BILATERAL TUBAL LIGATION USING SUTURES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8292504 ↗
• Jan 6, 2017No Apparent Adverse Event; No Apparent Adverse Event

  FEMCARE-NIKOMED RECEIVED THE FOLLOWING REPORT FROM FDA VIA A MEDWATCH REPORT SUBMITTED BY A PATIENT, REFERENCE MW5064826. THE PATIENT HAD A BILATERAL TUBAL LIGATION WITH FILSHIE CLIPS IN 2014. WITHIN 6 WEEKS OF THE TUBAL LIGATION PROCEDURE PATIENT REPORTED SHE BEGAN SUFFERING FROM A NUMBER OF SYMPTOMS INCLUDING; JOINT PAIN, HAIR LOSS, BREAST PAIN, CYSTIC ACNE, ENLARGED LYMPH NODES, NASAL ALLERGIES, FATIGUE, SHORT TERM MEMORY ISSUES, LIGHT HEADED/DIZZINESS, SHORTNESS OF BREATH, HEAVY MENSTRUAL CYCLES AND BILATERAL PELVIC PAIN/BURNING SENSATION. THE PATIENT STATED THAT SHE HAS A NICKEL ALLERGY. THE PATIENTS' DOCTOR AGREED THE CLIPS NEEDED TO BE REMOVED. THE PATIENT HAD A LAPAROSCOPIC BILATERAL SALPINGECTOMY WITH FILSHIE REMOVAL IN 2016. ENLARGED VEINS WERE VIEWED ON AND AROUND THE PATIENTS' UTERUS REPORTEDLY SIGNALLING PELVIC CONGESTION. THE PATIENT BELIEVES THE FILSHIE CLIPS PLAYED A ROLE IN THE DEVELOPMENT OF PELVIC CONGESTION AND WERE THE CAUSE OF THE OTHER SYMPTOMS REPORTED. THE PATIENT REPORTS THAT WITH THE EXCEPTION OF HAIR LOSS, ALL SYMPTOMS HAVE CEASED.

  Patient problems: Complaint, Ill-Defined; Discomfort; Increased Sensitivity

  MAUDE report 6228146 ↗
• Jan 4, 2017No Apparent Adverse Event; No Apparent Adverse Event

  FEMCARE-NIKOMED RECEIVED THE FOLLOWING REPORT FROM FDA VIA A MEDWATCH REPORT SUBMITTED BY A MEDICAL FACILITY RISK MANAGER, REFERENCE MW5064294. PATIENT HAD A FILSHIE TUBAL LIGATION PROCEDURE (B)(6) 2016. POST-OP THE PATIENT COMPLAINED OF PAIN, CRAMPING AND DISCOMFORT. PATIENT WAS RE-ADMITTED FOR REMOVAL OF FILSHIE CLIPS ON (B)(6) 2016.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 6221833 ↗