Omni-Tract® 4040Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780270638), received between Mar 5, 2025 and Feb 5, 2026 — classified as 3 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Jun 5, 2026Open, Classified

   The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.

   Z-2714-2026 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Break

  A FACILITY REPORTED THAT DURING A SURGICAL PROCEDURE, THE SNAP CLAMP ASSEMBLY (4040) EXHIBITED A DEFECT, WHICH WAS A TIGHTENING PROBLEM ON THE HOOP THAT RESULTED IN A 30-MINUTE DELAY IN SURGICAL TIME. ANOTHER SURGICAL INSTRUMENT WAS USED TO COMPLETE THE SURGERY. NO PATIENT INJURIES OR DEATHS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24267958 ↗
• MalfunctionJul 1, 2025Mechanical Problem; Mechanical Problem

  A FACILITY ENGINEER REPORTED THAT THE CLAMPING FORCE OF THE SNAP CLAMP ASSEMBLY (4040) ON THE RETRACTOR ROD WAS "TOO LOW, THAT THE CLAMP YIELDS TO TISSUE PRESSURE." THERE WAS NO PATIENT INJURY; HOWEVER, A SURGICAL DELAY EXCEEDING 30 MINUTES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22375287 ↗
• MalfunctionMar 5, 2025Break; Break

  A FACILITY REPORTED THAT DURING A "HIGHLY COMPLEX DIGESTIVE SURGERY INVOLVING A PANCREATICODUODENECTOMY WITH VASCULAR RESECTION", THE SNAP CLAMP ASSEMBLY (4040) "SPONTANEOUSLY BROKE WHILE BEING MANIPULATED." THE BROKEN RETRACTOR DID NOT FALL INTO THE SURGICAL SITE, AND ALL BROKEN PARTS WERE SUCCESSFULLY RECOVERED. THERE WAS NO INJURY TO THE PATIENT; HOWEVER, A SURGICAL DELAY OF TWO HOURS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21532619 ↗