COR-KNOT MINI® 031350Recalls & reported problems
LSI Solutions, Inc. · COR-KNOT MINI® COMBO KIT · Class 1 · Implant
Quick summary
This LSI Solutions COR-KNOT MINI is a surgical device that ties and cuts suture knots, used mainly during heart valve surgery. The 32 reports describe the device failing mid-operation — not deploying or firing, knots getting stuck inside it, and the suture being cut before it was secured, which surgeons say can leave a loose stitch and leak around the valve. Reports mention 2 deaths and 4 injuries. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 2
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00850200006292), received between Feb 8, 2019 and Nov 14, 2025 — classified as 2 deaths, 4 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Failure to Fire2
- Insufficient Device Problem Information2
- Activation Problem1
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Entrapment of Device1
- Failure to Cut1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Insufficient Information7
- Chest Pain2
- Atrial Fibrillation1
- Cardiac Perforation1
- Death1
- Failure of Implant1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2025Failure to Fire
AFTER PROPER IDENTIFICATION, PATIENT WAS BROUGHT TO THE OPERATING ROOM AND PLACED ON THE TABLE IN SUPINE POSITION. GENERAL ANESTHESIA WAS GIVEN, INSERTION OF SWAN-GANZ CATHETER AND CHEST, ABDOMEN AND LEGS WERE PREPPED AND DRAPED IN STERILE FASHION. DURING THE PROCEDURE FOR THE AORTIC VALVE, COR-KNOT WAS USED TO TIE ALL THE SUTURES. HOWEVER, THE COR-KNOT DID NOT COMPLETE FIRING. THE DEVICE WAS EXCHANGED FOR ANOTHER SIMILAR DEVICE AND THE OPERATION WAS COMPLETED WITHOUT ANY FURTHER INCIDENCE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23554595 ↗MalfunctionNov 14, 2025Failure to Cut; Failure to Fire
PATIENT WAS TAKEN TO THE OPERATING ROOM AND PLACED ON THE TABLE IN THE SUPINE POSITION. GENERAL ANESTHESIA WAS INDUCED; LINES AND MONITORING DEVICES WERE PLACED. PATIENT'S CHEST WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. WHEN IT WAS TIME TO DO THE AVR [AORTIC VALVE REPLACEMENT], THE AORTIC VALVE WAS INSPECTED AND THERE APPEARED TO BE A CALCIFIED LESION DISTORTING THE RIGHT CORONARY LEAFLET. NEAR THE END OF THE AVR, SUTURES WERE PLACED THROUGH THE SEWING CUFF OF THE VALVE AND FASTENED IN PLACE USING COR-KNOTS. HOWEVER, THE FIRING MECHANISM STOPPED AT 8 AND IT STOPPED CUTTING WIRE. THE DEVICE WAS EXCHANGED FOR ANOTHER ONE AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER INCIDENT. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23554375 ↗MalfunctionSep 17, 2025Perivalvular Leak; Protective Measures Problem; Premature Separation
FROM STAFF: COR - KNOT MINI DEVICE MALFUNCTION, DEVICE IS CUTTING THE SUTURE PREMATURELY. INTRAOPERATIVELY, SAID DEVICE CUT THE SUTURE BEFORE HAVING THE SUTURE SECURED WITH INTERLOCKING ATTACHMENT FROM SAID DEVICE. HAVING THAT INTO CONSIDERATION, THAT IS A RISK FOR THE SUTURE TO BE LOOSE AND MOVABLE, FURTHER CAUSING PERI VALVULAR LEAK OR MAY RESULT FOR THE IMPLANTED VALVE TO BE RENDERED INEFFECTIVE AND CAUSE PATIENT HARM. THE SAID DEVICE HAS REF# 031350. DEVICE WAS TAKEN OUT OF THE FIELD AS SOON AS MALFUNCTIONING WAS NOTICED, DEVICE WAS PUT IN ITS ORIGINAL PACKAGING AND PLACED IN A BIOHAZARDOUS BAG.
Patient problems: Failure of Implant
MAUDE report 23072368 ↗MalfunctionSep 15, 2025Mechanical Jam; Activation Problem
DID NOT DEPLOY PROPERLY; KNOT STUCK IN THE DEVICE.
Patient problems: Insufficient Information
MAUDE report 23050531 ↗MalfunctionApr 4, 2025
THE COR-KNOT DEVICE MALFUNCTIONED AND COULD NOT BE LOADED INTO THE MECHANISM. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21772063 ↗MalfunctionApr 4, 2025
WHEN THE COR-KNOT DEVICE WAS IN USE, IT WOULD NOT DEPLOY AND WAS REPLACED WITH A NEW DEVICE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21772060 ↗MalfunctionMar 14, 2025
PATIENT WAS DIAGNOSED TO HAVE SEVERE AORTIC VALVE STENOSIS. CARDIAC CATHETERIZATION WAS ALSO THEN PERFORMED WHICH REVEALED NONOBSTRUCTIVE CORONARY ARTERY DISEASE. PATIENT IS NOW REFERRED FOR POSSIBLE AORTIC VALVE INTERVENTION. PATIENT WAS IN THE SURGICAL SUITE FOR AN AORTIC VALVE REPLACEMENT. A TIMEOUT WAS COMPLETED, VERIFYING CORRECT PATIENT, PROCEDURE SITE AND POSITIONING. GENERAL ANESTHESIA WAS INDUCED, AND CENTRAL VENOUS ACCESS WAS OBTAINED. AN ARTERIAL LINE AND FOLEY CATHETER WERE PLACED, A SWAN-GANZ CATHETER WAS POSITIONED, AND A TEE PROBE WAS PLACED. THE PATIENT WAS THEN POSITIONED, PREPARED AND DRAPED IN A STERILE MANNER. A COR-KNOT MINI COMBO DEVICE WAS USED TO SECURE THE SUTURES. PER RN REPORT: THE BLADES WERE DULLING BEFORE 6 CUTS WERE MADE AND THEY WERE NOT CUTTING THE SUTURES. THE DEVICE WAS REPLACED WITH ANOTHER SIMILAR ONE AND THE PROCEDURE WAS CONCLUDED WITH NO FURTHER INCIDENT. NO PATIENT HARM. MANUFACTURER RESPONSE FOR INSTRUMENT, LIGATURE PASSING AND KNOT TYING, COR-KNOT MINI® (PER SITE REPORTER). DEVICE AND INFO GIVEN TO MED FIELD REPRESENTATIVE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21605440 ↗MalfunctionJan 23, 2025
COR-KNOT DEVICE WOULD NOT CUT THE KNOTS PROPERLY.
Patient problems: Insufficient Information
MAUDE report 21217059 ↗MalfunctionJan 23, 2025
THE COR-KNOT MINI DEVICE HANDLE DID NOT ADEQUATELY DEPLOY. DEVICE REMOVED FROM THE OPERATING ROOM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21216829 ↗MalfunctionDec 6, 2024
THE COR-KNOT MINI DEVICE WOULD NOT COMPLETELY DEPLOY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20863332 ↗MalfunctionNov 7, 2024
COR KNOT MINI COMBO KIT - IT WAS NOT CATCHING WHILE TRYING TO DEPLOY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20629267 ↗MalfunctionOct 22, 2024
> 60-YEAR-OLD MALE WITH HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, GUILLIAN-BARRE AND RECENT ABNORMAL STRESS TEST. PATIENT UNDERWENT CORONARY ARTERY BYPASS SURGERY WITH AORTIC VALVE REPLACEMENT AND MITRAL VALVE REPLACEMENT. DURING SURGERY COR-KNOT DEVICE GOT STUCK WHILE TRYING TO USE IT. NO KNOWN HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20504603 ↗MalfunctionOct 18, 2024
OVER 70-YEAR-OLD PATIENT WITH HISTORY OF SEVERE MITRAL REGURGITATION UNDERWENT MITRAL VALVE REPAIR. WHEN SCRUB NURSE WAS LOADING THE SUTURE THREADER ON THE DEVICE, CARRIER NOT LOADING FLUSH ON THE DEVICE. NEVER INSERTED OR USED ON THE PATIENT. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20480866 ↗MalfunctionOct 17, 2024
GROMMET DID NOT TIGHTEN THE SUTURE DOWN, IT JUST CUT THE STRINGS. GROMMET CUT SUTURE AS IT WAS PULLED THROUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20469862 ↗MalfunctionOct 1, 2024
ELDERLY MALE WITH HISTORY OF MULTIVESSEL CORONARY ARTERY DISEASE AND ABNORMAL STRESS TEST WITH SUSPECTED AORTIC STENOSIS. UNDERWENT CORONARY ARTERY BYPASS GRAFT X 4 WITH AORTIC VALVE REPLACEMENT. DURING PROCEDURE, ONE OF THE COR-KNOT DEVICES DID NOT RELEASE THE SUTURE AFTER FIRING. THE SUTURE NEEDED TO BE CUT AND A NEW STITCH HAD TO BE PLACED. NO KNOWN HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20343944 ↗MalfunctionSep 13, 2024
COR-KNOT DEVICE DEFECTIVE DOES NOT CRIMP THE COR-KNOT AND RELEASE KNOT.
Patient problems: Insufficient Information
MAUDE report 20211848 ↗MalfunctionSep 13, 2024
COR-KNOT DEVICE WOULD NOT PROPERLY CRIMP AND RELEASE THE COR-KNOTS.
Patient problems: Insufficient Information
MAUDE report 20211825 ↗MalfunctionSep 12, 2024
WHEN THE COR-KNOT DEVICE WAS USED TO SECURE THE VALVE IN PLACE ON THE RIGHT TO NONCORONARY COMMISSURE, ONE OF THE SUTURE PLACEMENTS WITH THE COR-KNOT DEVICE HAD TO BE REPLACED AS THE DEVICE MALFUNCTIONED. THE GUNS ON THE DEVICE BECAME JAMMED AND WOULD NOT WORK CORRECTLY.
Patient problems: Insufficient Information
MAUDE report 20199555 ↗MalfunctionSep 12, 2024
DURING THE SURGERY, THE COR-KNOT MINI DEVICE MALFUNCTIONED. THE DEPLOYMENT GUNS WERE ORIGINALLY WORKING. WITH CONTINUED USE, THEY STARTED TO JAM, AND THE DEVICE WAS REPLACED WITH ANOTHER NEW DEVICE. NO APPARENT PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20199251 ↗MalfunctionSep 12, 2024
THE COR-KNOT HANDLE WAS FOUND TO MALFUNCTION. IT WOULD NOT CLOSE OR DISPENSE PROPERLY. THE DEVICE WAS REMOVED FROM THE OR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20199087 ↗MalfunctionJun 14, 2024
MalfunctionJun 14, 2024
WOULD NOT CUT OFF THE COR-KNOTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19536221 ↗MalfunctionFeb 16, 2024
UNKNOWN - DEVICE WAS SENT TO RISK MANAGEMENT FOR REPORTING WITHOUT DESCRIPTION OF MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18720095 ↗InjuryDec 19, 2023
ELDERLY MALE WITH HISTORY OF CORONARY ARTERY DISEASE, RECENT CHEST PAIN AND ATRIAL FIBRILLATION. PROCEDURE: CORONARY ARTERY BYPASS X2 AND AORTIC VALVE REPLACEMENT. THE COR-KNOT MALFUNCTIONED WHEN FIRED DURING THE PLACEMENT OF THE AORTIC VALVE. THE DEVICE JAMMED AND BROKE THE 2.0, V-7 ETHIBOND VALVE SUTURE; THE END JAMMED IN DEVICE. THE PLEDGET HAD TO BE REMOVED AND ADDITIONAL SUTURING WAS PUT IN PLACE. NO KNOWN HARM TO PATIENT AT THIS TIME. MANUFACTURER RESPONSE FOR INSTRUMENT, LIGATURE PASSING AND KNOT TYING, COR-KNOT MINI (PER SITE REPORTER), WILL OBTAIN WHEN AVAILABLE.
Patient problems: Atrial Fibrillation; Chest Pain
MAUDE report 18353532 ↗MalfunctionDec 3, 2023No Apparent Adverse Event; No Apparent Adverse Event
ON 03 NOV 2023, WE RECEIVED A COPY OF A MEDWATCH REPORT (B)(4) FILED BY THE AULTMAN HOSPITAL IN CANTON, OHIO. AS REPORTED IN THE MEDWATCH REPORT, AN (B)(6) MALE WAS HAVING CONCOMITANT PROCEDURES OF 1) A DOUBLE CORONARY ARTERY BYPASS GRAFT AND 2) A MITRAL VALVE REPLACEMENT. THE MEDWATCH REPORT STATES, "MITRAL VALVE SUTURES WERE IN PLACE, COR-KNOT DEVICE USED TO CINCH DOWN SUTURES AND THEN CUT SUTURES. DEVICE MALFUNCTIONED ON ONE SUTURE AND CUT SUTURE BEFORE CINCHING. SURGEON PUT IN TWO ADDITIONAL VALVE SUTURES THROUGH NATIVE VALVE AND VALVE REPLACEMENT TO ENSURE VALVE REPLACEMENT INTEGRITY." THE MEDWATCH REPORT ALSO STATED, "NO KNOWN HARM TO PATIENT." OUR FOLLOW-UP WITH THE HOSPITAL ALSO DETERMINED THAT THE REPORTED ISSUE OCCURRED APPROXIMATELY HALFWAY THROUGH THE SECURING OF THE VARIOUS SUTURES AROUND THE SEWING CUFF OF THE REPLACEMENT MITRAL VALVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18253520 ↗
Other Instrument, Ligature Passing And Knot Tying devices
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- IDEAL 251003Medos International Sàrl · INSTRUMENT, LIGATURE PASSING AND KNOT TYING87 reports
- OverStitch Endoscopic Suturing System ESS-G02-160Apollo Endosurgery, Inc. · Instrument, Ligature Passing And Knot Tying4 deaths76 reports
- M-Close Kit 27-101New Wave Endo-Surgery Inc. · Instrument, Ligature Passing And Knot Tying1 recall3 reports
- AESCULAP MB362RAesculap, Inc. · INSTRUMENT, LIGATURE PASSING AND KNOT TYING1 recall0 reports
- AESCULAP MB215RAesculap, Inc. · INSTRUMENT, LIGATURE PASSING AND KNOT TYING1 recall0 reports
- OverStitch Endoscopic Suturing System CNH-G01-000Apollo Endosurgery, Inc. · Instrument, Ligature Passing And Knot Tying48 reports
- IDEAL 251004Medos International Sàrl · INSTRUMENT, LIGATURE PASSING AND KNOT TYING42 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.