COAPTIUM® Connect NCOCO3010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03760279380117), received between Mar 26, 2026 and Mar 26, 2026 — classified as 1 injury.

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-2905-2026 · 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.

• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  ON 26 JANUARY 2026, A COAPTIUM® CONNECT DEVICE WAS SUCCESSFULLY IMPLANTED TO REPAIR THE RADIAL DIGITAL NERVE OF THE THUMB FOLLOWING A TRAUMATIC INJURY. APPROXIMATELY FOUR WEEKS POST-OPERATIVELY, THE PATIENT PRESENTED WITH WOUND DEHISCENCE. THE DEVICE REMAINED IN SITU, WITH NO REPORTED EXTRUSION. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2026 TO EXPLORE THE REPAIR SITE AND ADDRESS THE WOUND COMPLICATION. INTRAOPERATIVELY, NO DEVICE MALFUNCTION OR ABNORMAL TISSUE RESPONSE WAS IDENTIFIED. THE DEVICE WAS EXPLANTED WITHOUT DAMAGE TO THE NATIVE NERVE TISSUE. SEPARATELY, DURING THE PROCEDURE, FAILURE OF THE TENDON REPAIR WAS OBSERVED, SUGGESTING SUBOPTIMAL POST-OPERATIVE COMPLIANCE. THE WOUND WAS DESCRIBED AS COLONIZED BUT WITHOUT SIGNS OF ACTIVE INFECTION. THERE IS NO EVIDENCE OF DEVICE MALFUNCTION, AND THE EVENT IS CONSIDERED PRIMARILY ATTRIBUTABLE TO PATIENT, PROCEDURAL, AND POST-OPERATIVE FACTORS.

  Patient problems: Wound Dehiscence

  MAUDE report 24700750 ↗