NOVOSTITCH CTX-R002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00853541006068), received between Aug 26, 2020 and Apr 13, 2022 — classified as 2 injuries.

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

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2022Break; Break

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, THE UPPER JAW OF THE 'NOVOSTITCH' WAS NOT GRABBING THE SUTURE ON THE RELOADS. TWO ADDITIONAL 'NOVOSTITCH' WERE OPENED WITH NOT SUCCESS. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION CONCLUDED THAT THE NEEDLE SLED WAS OUT OF PLACE AND PARTIALLY DETACHED WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14105276 ↗
• InjuryAug 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE NOVOSTITCH CARTRIDGE BROKE INSIDE THE PATIENT AND THE PIECE WAS SUCCESSFULLY REMOVED FROM PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED HOWEVER NO SIGNIFICANT DELAY AND NO PATIENT COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Not Applicable

  MAUDE report 10454610 ↗