COR-KNOT® 031082Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850200006278), received between Dec 9, 2020 and Dec 9, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 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.

• InjuryDec 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  COR-KNOT® MIS TITANIUM FASTENERS WERE USED TO SECURE THE SUTURES TO HOLD THE PROSTHETIC MITRAL REPLACEMENT VALVE DURING SURGERY. THE 11TH FASTENER WAS REPORTED DIFFICULT TO RELEASE FROM THE COR-KNOT® MIS DEVICE. THEY REPORT, "WHILE ATTEMPTING TO FREE THE DEVICE, THE SUTURE TORE, AND THE RIVET CAME FREE WITH THE DEVICE." THE SURGEON REMOVED AND REPLACED THE PROSTHETIC MITRAL VALVE. THEY REPORTED THEY WERE UNABLE TO FIND 3 OF THE 11 VENTRICULAR PLEDGETS USED WITH THE FIRST PROSTHETIC MITRAL VALVE. THEY FURTHER NOTED CONCERN REGARDING "PROLONGED CARDIOPULMONARY BYPASS PUMP TIME AS THE VALVE HAD TO BE REPLACED". THE PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY FOR A POST-UP RECOVERY.

  Patient problems: Insufficient Information

  MAUDE report 10979451 ↗