COAPTIUM® Connect NCOCO6010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03760279380209), received between Feb 24, 2026 and Feb 24, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 15, 2026Open, Classified

   Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

   Z-2908-2026 · Root cause: Incorrect or no expiration date · FDA record ↗

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.

• MalfunctionFeb 24, 2026Fracture; Material Integrity Problem

  DURING A LEFT ULNAR NERVE RECONSTRUCTION USING TWO COAPTIUM® CONNECT DEVICES, AN APPROXIMATELY 3 MM FRACTURE LINE WAS OBSERVED NEAR THE DISTAL RIDGE REGION OF THE PROXIMAL COAPTATION CHAMBER WHILE ACCOMMODATING A NERVE MEASURING APPROXIMATELY 7 MM INTO A 6 MM CHAMBER. NO FRAGMENT DETACHMENT WAS OBSERVED AND NO MATERIAL WAS RETAINED; THE DEVICE WAS NOT REPLACED. AT THE DISTAL REPAIR SITE, FIXATION TO THE POSTERIOR EPINEURIUM WAS INCOMPLETE AND TWO SUTURES WERE PLACED THROUGH THE CHAMBER AND EPINEURIUM TO COMPLETE THE REPAIR. THE PROCEDURE WAS PROLONGED BY APPROXIMATELY 30 MINUTES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430041 ↗