Chord-X Premeasured Loops and Suture System CXL-20-1838-20Recalls & reported problems
On-X Life Technologies, Inc. · Artificial choral replacement prosthesis · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813570020282), received between Jan 3, 2025 and Apr 28, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 28, 2025Break; Break
ACCORDING TO THE REPORT, THE CHORD-X SUTURES ALL BROKE ABOVE THE PLEDGETS AT THE BASE OF THE PAPILLARY MUSCLE, RESULTING IN THE PATIENT'S VALVE NEEDING REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21921721 ↗InjuryJan 3, 2025Break; Break
ACCORDING TO THE INITIAL REPORT, AFTER IMPLANT OF THIS CHORD-X DEVICE, IT WAS DISCOVERED THAT THE PAPILLARY STITCH/ARM HAD BEEN CUT/SEVERED AND RELEASED FROM THE PAPILLARY MUSCLE. SURGEON STATED THEY COULD NOT FIND THE PLEDGET THAT SLIPPED OFF THE BROKEN PAPILLARY ANCHOR AND BELIEVED IT MUST HAVE BEEN LOST IN THE PATIENT'S LEFT VENTRICLE.
Patient problems: Foreign Body In Patient
MAUDE report 21068858 ↗
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 · TerminatedChord-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
Other Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement devices
- Chord-X Premeasured Loops and Suture System CXL-20-1812-20On-X Life Technologies, Inc. · Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement1 report
- Chord-X Premeasured Loops and Suture System CXL-20-1812-16On-X Life Technologies, Inc. · Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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