COR-KNOT® 030800Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00850200006100), received between Aug 31, 2018 and Mar 26, 2025 — classified as 1 death, 3 injuries, 7 malfunctions.

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

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• DeathMar 26, 2025Mechanical Problem; Mechanical Problem

  THE HOSPITAL VERBALLY REPORTED THAT A PATIENT HAD UNDERGONE A SURGICAL MITRAL VALVE REPLACEMENT PROCEDURE WHERE A COR-KNOT® MIS DEVICE WAS USED TO SECURE SUTURE DURING THE OPERATION. THE VERBAL REPORT WAS THAT A SCRUB NURSE WAS HAVING DIFFICULTY LOADING THE COR-KNOT® DEVICE. IT WAS ALSO REPORTED THAT THE DEVICE APPEARED TO CUT THE SUTURE BUT DID NOT CRIMP A TITANIUM FASTENER ONTO THE SUTURE AND, THEREFORE, COULD NOT BE USED. IT IS UNKNOWN WHETHER THE SURGEON SUBSEQUENTLY USED A DIFFERENT COR-KNOT® DEVICE TO SECURE SUTURE OR IF THE SURGEON SWITCHED TO HAND-TIED KNOTS FOR SECURING THE SUTURE. THE PATIENT WAS REPORTED TO HAVE BEEN SENT TO THE INTENSIVE CARE UNIT (ICU) AFTER LEAVING THE OPERATING ROOM (OR). THE PATIENT WAS DESCRIBED AS "A VERY SICK PATIENT" AT THAT TIME. THE PATIENT LATER EXPIRED IN THE ICU.

  Patient problems: Insufficient Information

  MAUDE report 21699381 ↗
• MalfunctionJan 31, 2024

  COR-KNOT DEVICES NOT LOADING INTO GUNS CORRECTLY AND NOT ALLOWING COR-KNOT TO PULL THROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613952 ↗
• InjuryJan 12, 2024Use of Device Problem; Use of Device Problem

  A SURGEON PERFORMED A MITRAL VALVE REPLACEMENT (MVR) PROCEDURE ON A PATIENT AT THE UNIVERSITY OF TENNESSEE HOSPITAL. THE SURGEON IMPLANTED THE PROSTHETIC MITRAL VALVE WITH SUTURES AND INTENDED TO SECURE THOSE SUTURES WITH COR-KNOT® TITANIUM FASTENERS INSTALLED WITH A COR­ KNOT® MIS DEVICE. AS REPORTED, FOUR COR-KNOT® MIS DEVICES WERE ATTEMPTED TO BE USED IN THIS MVR SURGERY, HOWEVER, THE HOSPITAL REPORTED THAT ALL FOUR DEVICES WERE DIFFICULT TO LOAD, AND A WIRE SNARE WAS BROKEN DURING AN ATTEMPT TO LOAD ONE OF THE DEVICES. ADDITIONALLY, AS REPORTED, ONE DEVICE WAS ABLE TO BE LOADED, BUT AFTER SQUEEZING THE DEVICE LEVER, THE DEVICE WAS REPORTED TO MISFIRE. THE SURGEON ELECTED NOT TO CONTINUE ATTEMPTING TO USE TITANIUM FASTENERS TO SECURE THE SUTURE AND INSTEAD SECURED THE SUTURES WITH HAND-TIED KNOTS. OUR UNDERSTANDING IS THAT THIS WAS THE END OF THE COR-KNOT® MIS DEVICE'S INVOLVEMENT IN THIS PROCEDURE. IT WAS FURTHER REPORTED THAT A PARAVALVULAR LEAK (PVL) WAS NOTED POSTOPERATIVELY AND THE SURGEONS DECIDED TO TAKE THE PATIENT BACK TO THE OPERATING ROOM TO ADDRESS THE PVL. WE BELIEVE THAT THE SUBSEQUENT PVL WAS NOT ASSOCIATED WITH USE OF OUR PRODUCT SINCE THE HOSPITAL INFORMED US HA

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 18507973 ↗
• InjuryDec 19, 2023

  MULTIPLE COR-KNOT LOADS BROKE AND MISFIRED. MULTIPLE COR-KNOTS USED, ALL WITH THE SAME LOT #.

  Patient problems: Insufficient Information

  MAUDE report 18353531 ↗
• MalfunctionDec 6, 2023

  THE DEVICE IS NOT WORKING, ESPECIALLY IN THE TIP PART WHEN ATTACHED TO THE COR-KNOT.

  Patient problems: Insufficient Information

  MAUDE report 18273740 ↗
• MalfunctionDec 6, 2023

  DOES NOT WORK; WILL NOT LOAD PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18273700 ↗
• MalfunctionDec 6, 2023

  FIRST COR-KNOT FIRED, RELEASED AND ACTUAL KNOT WAS RETAINED IN DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18273576 ↗
• MalfunctionSep 26, 2023

  DOCTOR WAS PERFORMING A MINIMALLY INVASIVE MITRAL VALVE REPAIR. DOCTOR USES A SINGLE USE DEVICE CALLED A "COR-KNOT" TO TIE VALVE SUTURES. THESE SEW IN THE PROSTHETIC HEART VALVE INTO THE PATIENT. TWICE, THE COR-KNOT DEVICE CUT A SUTURE. DR. HAD TO RETRIEVE THE SUTURE¿S PLEDGETS THAT HAD FALLEN INTO THE PATIENT¿S LEFT ATRIUM. THE VALVE WAS ALREADY IN PLACE AND NEARLY ALL OF THE SUTURES WERE TIED. AS A RESULT OF THE BROKEN SUTURES, THE VALVE "LEAKED" AND TO CORRECT THAT, THE SURGEON HAD TO RE-DO THOSE SUTURES. ANOTHER COR-KNOT DEVICE WAS OPENED, AND IT TOO, BROKE A SUTURE. DR. TOLD THE SURGICAL TEAM, AND THE ANESTHESIOLOGIST PERFORMING THE TRANSESOPHAGEAL ECHOCARDIOGRAM PRIOR TO COMING OFF CARDIOPULMONARY BYPASS, THAT IF THE PATIENT'S LEFT VENTRICLE DISTENDED DUE TO ANY PERIVALVULAR LEAK, THEN HE WOULD HAVE TO REMOVE THE VALVE AND DO THE REPLACEMENT ALL OVER AGAIN. THERE WERE A TOTAL OF THREE SUTURES THAT WERE BROKEN BETWEEN THE USE OF THE DEVICE(S). BOTH DEVICES HAD THE SAME LOT NUMBER.

  Patient problems: Foreign Body In Patient; Valvular Insufficiency/ Regurgitation

  MAUDE report 17820639 ↗
• MalfunctionMay 24, 2023Misfire; Defective Device

  DURING AN EMERGENT SURGERY PROCEDURE OF A CRITICAL PATIENT WITH LARGE PERCIARDIAL EFFUSION, A 21 MM EDWARDS BOVINE PERICARDIAL VALVE INFRA ANNULAR SUTURES WERE PLACED CIRCUMFERENTIALLY PASSED THROUGH THE SEWING RING OF THE VALVE AND THE VALVE WAS LOWERED INTO POSITION AND THEN THE SUTURES WERE TIED USING THE CORE KNOT DEVICE. UNFORTUNATELY, THERE WERE 3 OR 4 MISFIRES OF THE COR-KNOT AND THE SUTURES COULD NOT BE REPLACED AND THEREFORE WAS ELECTED TO TAKE THAT VALVE OUT. WE REPLACED THE SUTURES, REPOSITION A NEW 21 MM VALVE AND THEN HAND TIED THE SUTURES. ONCE THE VALVE WAS SEATED CORRECTLY SUTURES WERE TIED APPEARED TO BE IN GOOD POSITION AND THEN THE AORTOTOMY WAS CLOSED IN A 2-LAYER TECHNIQUE AS USUAL. THE PATIENT LEFT SURGERY AND WAS TRANSPORTED TO THE INTENSIVE CARE UNIT IN CRITICAL CONDITION INTUBATED. THE COR-KNOT DEVICE THAT FAILED WAS SAVED AND GIVEN TO THE SALES REPRESENTATIVE TO RETURN TO THE MANUFACTURER FOR INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991508 ↗
• MalfunctionDec 3, 2018Break

  THE COR-KNOT DEVICE STARTED BREAKING THE SUTURE AND THE GROMMET BROKE INSIDE THE UNIT. IT RELEASED THE GROMMET PREMATURELY WHEN ENGAGING THE DEVICE. THE PARTS WERE RETRIEVED AND ISOLATED FROM THE CASE. (THE BROKEN GROMMET IS INSIDE THE PACKAGE). THERE WERE NO COMPLICATIONS. NOTES FROM THE OPERATIVE REPORT: "...THE ANNULUS WAS ENCIRCLED WITH 13 PLEDGETED 2-0 ETHIBOND SUTURES. THESE WERE PASSED THROUGH THE VALVE. THE VALVE WAS SEATED AND TIED DOWN WITH A COR-KNOT DEVICE. THE AORTA WAS CLOSED IN 2 LAYERS OF 4-0 PROLENE PLEDGETED AT EITHER END."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8124034 ↗
• InjuryAug 31, 2018Failure to Fire; Failure to Fire

  A (B)(6) PATIENT REQUIRED THE PLACEMENT OF THREE PROSTHETIC VALVES IN THE MITRAL LOCATION DURING A SURGICAL MITRAL VALVE REPLACEMENT PROCEDURE. SEVENTEEN (17) SUTURES WERE PLACED AROUND THE MITRAL ANNULUS FOR THE FIRST PROSTHESIS INSTALLATION ATTEMPT. AFTER SUCCESSFULLY SECURING THE FIRST 11 SUTURES WITH COR-KNOT® TITANIUM FASTENERS USING TWO COR-KNOT® MIS DEVICES FROM THE SAME KIT, THE 12TH SUTURE BROKE PRIOR TO CRIMPING THE FASTENER. IT IS UNCLEAR WHETHER THE ACTUATING LEVER OF THE DEVICE WAS SQUEEZED DURING THE SUTURE BREAKAGE. THE DEVICE WITH THE UNCRIMPED FASTENER STILL IN THE DEVICE TIP WAS REMOVED FROM THE PATIENT. THE SURGEON REMOVED THIS FIRST PROSTHETIC VALVE ALONG WITH THE SUTURES AND THE INSTALLED TITANIUM FASTENERS. WHILE SECURING THE SECOND MITRAL PROSTHESIS, THE SURGEON NOTICED UNEXPECTED BLEEDING AND DETERMINED AN ATRIO-VENTRICULAR GROOVE DISSOCIATION HAD OCCURRED. THIS COMPLICATION REQUIRED THE REMOVAL OF THE SECOND PROSTHESIS TO ENABLE THE REPAIR OF THE DISSOCIATION. AFTER COMPLETION OF THE DISSOCIATION REPAIR, A THIRD PROSTHESIS WAS SUCCESSFULLY INSTALLED. NOTE: THE SURGEON ELECTED TO OPEN A SECOND KIT OF TWO COR-KNOT® MIS DEVICES TO USE TO SECURE THE SECOND PROS

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Sepsis

  MAUDE report 7836855 ↗