Chord-X Premeasured Loops and Suture System CXL-20-1812-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813570020220), received between Dec 31, 2025 and Dec 31, 2025 — 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.

• InjuryDec 31, 2025Break; Defective Component; Break; Defective Component

  ACCORDING TO THE INITIAL REPORT, THE CHORD-X SUTURE BROKE DOWN AT THE PAPILLARY MUSCLE LEVEL. THE SUTURE BROKE AFTER THE CLAMP CAME OFF SO HE HAD HE TO GO BACK ON, FOUND ONE OF THE PLEDGETS BUT THE OTHER ONE WAS GONE. HE DID A RE-REPAIR WITH CHORD X AGAIN AND WAS PERFECT BUT HAD TO GO TO CT TO GO SEARCHING AROUND FOR THIS PLEDGET. NEEDED CATH LAB SNARING AND FINALLY ENDED WELL AND PTS IS DOING GREAT. THEY DID NOT KEEP THE EXPLANTED CHORDS FOR EXAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934346 ↗

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