Anastoclip AC Closure System 4000-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840663102389), received between Jan 22, 2016 and Jan 22, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K962043); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  SPINE DURAL RUPTURE DURING LAMINECTOMY. 15MM INCISION CLIPPED WITH ANSTOCLIP VCS SIZE XL. CLIPS HAVE BEEN APPLIED NO MORE THAN 0.8-1.0 MM BETWEEN EACH OTHER. ADDITIONAL HEMOSTATIC AGENT ON TOP. NO FILTRATION AFTER VALSAVA TECHNIQUE APPLIED. REQUIRED A REVISION SURGERY 3 DAYS POST PROCEDURE BECAUSE OF SPINE DURAL FISTULA. DURING REVISION DR. CHAVEZ FOUND THAT CLIPS WERE OUT OF PLACE.

  Patient problems: Fistula

  MAUDE report 5385938 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962043. One submission often covers many models, so check the product and lot details in each record.

• Z-2286-2016 · Jun 22, 2016 · Terminated
  AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anasto
• Z-2287-2016 · Jun 22, 2016 · Terminated
  AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastocl
• Z-2285-2016 · Jun 22, 2016 · Terminated
  Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1 Each} X-Large REF # 4000-08 The Anastoclip Clip applier consists of a rotating shaft and
• Z-2288-2016 · Jun 22, 2016 · Terminated
  AnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anasto
• Z-2284-2016 · Jun 22, 2016 · Terminated
  AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoc
• Z-2283-2016 · Jun 22, 2016 · Terminated
  Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoc
• Z-2289-2016 · Jun 22, 2016 · Terminated
  AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastocl