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COR-KNOT MINI® 031300Recalls & reported problems

LSI Solutions, Inc. · COR-KNOT MINI® DEVICE KIT · Class 1 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850200006070), received between Mar 30, 2023 and Mar 30, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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

Device problems

  • Defective Device1
  • Failure to Cut1
  • Failure to Disconnect1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 30, 2023Failure to Disconnect; Failure to Cut; Defective Device

    COR-KNOT MINI DEVICE DEFECTIVE DURING AORTIC VALVE REPLACEMENT/CORONARY ARTERY BYPASS GRAFTING (AVR/CABG). DID NOT WANT TO CUT/RELEASE SUTURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16643618 ↗

Other Instrument, Ligature Passing And Knot Tying devices

All Instrument, Ligature Passing And Knot Tying devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.