COR-KNOT MINIRecalls & reported problems across all models
LSI Solutions, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 33
- Deaths reported
- 2
- Injuries reported
- 4
- Recalls
- 0
We found 2 models of COR-KNOT MINI by LSI Solutions, Inc. in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Feb 8, 2019 and Nov 14, 2025 — classified as 2 deaths, 4 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported COR-KNOT MINI problems
Device problems
- Failure to Cut2
- Failure to Fire2
- Insufficient Device Problem Information2
- Activation Problem1
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Defective Device1
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Insufficient Information7
- Chest Pain2
- Atrial Fibrillation1
- Cardiac Perforation1
- Death1
- Failure of Implant1
- No Known Impact Or Consequence To Patient1
COR-KNOT MINI models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- COR-KNOT MINI® 031350Instrument, Ligature Passing And Knot Tying2 deaths32 reports
- COR-KNOT MINI® 031300Instrument, Ligature Passing And Knot Tying1 report
Recent COR-KNOT MINI adverse event reports
The 15 most recent reports across all models, 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 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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