Anastoclip AC Closure System 4000-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840663102372), received between Jan 22, 2016 and Mar 27, 2019 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (2 reports).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 27, 2019Mechanical Jam; Mechanical Jam

  ONE LARGE ANASTOCLIP VCS APPLIERS FAILED TO CLOSE THE VASCULAR TISSUE PROPERLY DURING ANASTOMOSIS. THIS IS REPORT 1 OF 2.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8458459 ↗
• MalfunctionMar 27, 2019Mechanical Jam; Mechanical Jam

  ONE LARGE ANASTOCLIP VCS APPLIERS FAILED TO CLOSE THE VASCULAR TISSUE PROPERLY DURING ANASTOMOSIS. THIS IS REPORT 2 OF 2.

  Patient problems: Failure to Anastomose

  MAUDE report 8458458 ↗
• InjuryJan 22, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  SPINE DURAL RUPTURE DURING LAMINECTOMY. 10MM INCISION CLIPPED WITH ANSTOCLIP VCS SIZE L. CLIPS WERE REPORTED TO 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. THE PROCEDURE NEEDED REVISION SURGERY 8 DAYS POST SURGERY BECAUSE OF DURAL FISTULA. DURING REVISION SURGERY DR. (B)(6) FOUND: CLIPS WERE ATTACHED JUST TO ONE SIDE OF TISSUE; CLIPS WERE OUT OF PLACE; LEAKAGE THROUGH THE SPACE BETWEEN CLIPS.

  Patient problems: Fistula

  MAUDE report 5385931 ↗
• InjuryJan 22, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  SPINE DURAL RUPTURE DURING LAMINECTOMY. 15MM INCISION CLIPPED WITH ANASTOCLIP VCS SIZE LARGE. CLIPS WERE REPORTED TO 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. THE PROCEDURE NEEDED REVISION SURGERY 24HRS POST OP. BECAUSE OF CSF LEAKAGE. IMAGING SHOWED INFILTRATION INTO THE PSOAS AND SURGICAL INCISION. DURING REVISION SURGERY DR. (B)(6) FOUND THAT: 1. CLIPS WERE OUT OF PLACE. 2. CLIPS WERE ATTACHED JUST TO ONE SIDE OF TISSUE. 3. CRACKED BORDERS OF THE TISSUE.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 5385923 ↗

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-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
• 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-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-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-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