AnastoClip GC 8cm (Medium) 4008-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840663109579), received between Mar 20, 2022 and Aug 6, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K091987); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2025Failure to Form Staple; Mechanical Jam; Failure to Form Staple; Mechanical Jam

  IT WAS REPORTED THAT DURING A BVT PROCEDURE, THE ANASTOCLIP GC CLIP APPLIER JAMMED AND STUCK ONTO THE PATIENT'S ARM AND COULD NOT GET IT TO RELEASE THE CLIP OR OFF THE PATIENT'S ARM. THEY HAD TO CUT OUT PART OF THE VEIN. DEVICE WAS CHECKED PRIOR TO USE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE OPERATION. NO OTHER ISSUES OR INJURY WERE REPORTED TO THE PATIENT.

  Patient problems: Infiltration into Tissue

  MAUDE report 22729546 ↗
• MalfunctionFeb 19, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT THE ANASTOCLIP GC CLIPS KEEPS MISFIRING. THE CLIP DEPLOYS WITHOUT COMPLETELY CLOSING. THE PRODUCT WAS NOT DIRECTLY USED ON THE PATIENT AND NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21417808 ↗
• MalfunctionFeb 19, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT THE ANASTOCLIP GC CLIPS WERE MISFIRING. THE CLIP DEPLOYS WITHOUT COMPLETELY CLOSING SO THEY FALL OFF. DEVICE WAS NOT DIRECTLY USED ON PATIENT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21417759 ↗
• MalfunctionAug 21, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT THE ANASTOCLIP GC CLIPS WERE NOT CLOSING AND GRIPPING PROPERLY WHEN USED DURING THE CASE. IT HAD TO BE REMOVED THEM FROM THE DURA DURING A TETHERED CORD PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20021675 ↗
• MalfunctionMay 12, 2023Loose or Intermittent Connection; Misfire; Loose or Intermittent Connection; Misfire

  IT WAS REPORTED THAT THE ANASTOCLIP GC MEDIUM CLIPS WERE MISFIRING AND THEN COMING OUT OF THE VESSEL HANGING/LOOSE AFTER BEING DEPLOYED. THERE WERE NO PATIENT INJURY. TWO DEVICES WERE INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16919011 ↗
• MalfunctionMay 12, 2023Loose or Intermittent Connection; Misfire; Loose or Intermittent Connection; Misfire

  IT WAS REPORTED THAT THE ANASTOCLIP GC MEDIUM CLIPS WERE MISFIRING AND THEN COMING OUT OF THE VESSEL HANGING/LOOSE AFTER BEING DEPLOYED. THERE WERE NO PATIENT INJURY. TWO DEVICES WERE INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16919006 ↗
• MalfunctionMar 20, 2022Difficult to Open or Close; Difficult to Open or Close

  CLIP WILL FALL OUT OR CLIP WILL BE PARTIALLY CRIMPED AFTER ACTIVATING THE APPLIER. FIVE OR SIX CLIPS WILL APPLY PERFECTLY AND THEN A SERIES OF 2-3 THAT FALL OUT UNCRIMPED OR DO NOT CLOSE COMPLETELY AFTER SQUEEZING THE APPLIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13830813 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091987. One submission often covers many models, so check the product and lot details in each record.

• Z-0165-2011 · Sep 22, 2010 · Terminated
  LeMaitre Vascular AnastoClip GC Vessel Closure System-Large Size Models: 4007-03 Large size 3 Pack 4008-03 Large size 10 Pack 4007-07 Large size 1 Pack Manufactured by LeMatire Vas
• Z-0164-2011 · Sep 22, 2010 · Terminated
  LeMaitre Vascular AnastoClip GC Vessel Closure System-Medium Size Models: 4007-02 Medium size 3 Pack 4008-02 Medium size 10 Pack 4007-06 Medium size 1 Pack Manufactured by LeMatire