Clip, Tubal Occlusion
FDA adverse event reports and recall history for clip, tubal occlusion (product code HGB), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 158
- Deaths
- 0
- Injuries
- 36
- Malfunctions
- 110
Reports per year
Source: FDA adverse event reports by year received, 2001–2020. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2013-09-19TerminatedPackaging
Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP.
Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping.
- 2009-11-17TerminatedPackaging
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 Instruments Corp., Vernon Hills, IL 60061; item 4986.90. Indicated for use for female sterilization (permanent contraception) by occluding the fallopian tubes
The sterile pouch seal may fail to remain intact during handling rendering the Hulka clip non-sterile.
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