Chord-X Premeasured Loops and Suture System CXL-20-1812-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813570020237), received between Oct 13, 2023 and Oct 13, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K141060); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryOct 13, 2023Break; Break

  ACCORDING TO INITIAL NOTIFICATION, "AFTER REPAIR OF MITRAL VALVE WITH CHORD-X, THE SURGEON DONE WATER TEST AND NOTICED A SPONTANEOUS BROKEN OF CHORD-X AND A LOSS OF PLEDGET. HE TRIED TO RECOVER THE PLEDGET WITH THE HELP OF ENDOSCOPE IN VENTRICLE WITHOUT SUCCESS, THE PLEDGET IS NOW MISSING."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17930346 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141060. One submission often covers many models, so check the product and lot details in each record.

• Z-1057-2017 · Dec 13, 2016 · Terminated
  Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigure