Hulka Clips 4986.90Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00861523000102), received between Apr 7, 2017 and Apr 2, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

2 other recalls cover devices cleared under the same FDA submission (P870080); 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.

• InjuryApr 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON MARCH 02, 2020, RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) RECEIVED MEDWATCH REPORT # MW5092897.. THE PATIENT REPORTED THEY HAD THEIR TUBES TIED AND FOR MANY YEARS THEY SUFFERED DIFFERENT SYMPTOMS AND PROBLEMS. PATIENT REPORTED HAVING TUBES TIED TWELVE AND A HALF (12.5) YEARS LATER AND DETERMINED THAT THE SYMPTOMS THEY WERE HAVING AND ISSUES WERE A REACTION TO THE HULKA CLIP.

  Patient problems: No Information

  MAUDE report 9918527 ↗
• MalfunctionMar 16, 2019Migration; Migration

  FOLLOW UP TO PROVIDE NEW INFORMATION TO FDA.

  Patient problems: Menstrual Irregularities; Pain

  MAUDE report 8426759 ↗
• InjuryApr 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED A PHONE CALL FROM A PATIENT INDICATING SHE HAD A DEVICE IMPLANTED AND NOW HAS "MANY HEALTH ISSUES." PATIENT REPORTED HAVING A TUBAL LIGATION IN (B)(6) 1993 WHEN DEVICES WERE IMPLANTED (PACKAGE CONTAINS TWO CLIPS, ONE FOR EACH FALLOPIAN TUBE).

  Patient problems: Foreign Body In Patient

  MAUDE report 6474246 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P870080. One submission often covers many models, so check the product and lot details in each record.

• Z-0037-2015 · Jul 9, 2014 · Terminated
  The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed i
• Z-0272-2010 · Oct 16, 2009 · Terminated
  Richard Wolf Hulka Clip; for single patient use only; a sterile tubal occluding device; 2 clips per procedure tray/pouch, 10 pouches per shipping carton; Richard Wolf Medical Inst