AnastoClip GC 8cm (Large) 4008-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840663109586), received between Jul 28, 2022 and Jul 28, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (1 report).

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

• MalfunctionJul 28, 2022Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE USER, THE CLIPS OF THE ANASTOCLIP DID NOT CLOSE PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15124974 ↗

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-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
• 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