ETHIBOND EXCEL PXX80NRecalls & reported problems
Ethicon, LLC · Green/White Braided Synthetic, Non-absorbable Surgical Suture · Class 2 · Implant
All models of ETHIBOND EXCEL (134)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10705031462281), received between Apr 1, 2024 and Apr 1, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation1
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.
MalfunctionApr 1, 2024Material Separation; Material Separation
IT WAS REPORTED THAT PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE RELEASED THE SUTURE AFTER PULLING IT THROUGH THE ANNULUS. THERE WAS A FRENCH NEEDLE THAT COULD BE USED TO PUT IT THROUGH THE SEWING RING. THE CUSTOMER NOTED THAT THERE WAS NO LOT NUMBER ON THE INSIDE PACKAGING. SURGERY WAS DELAYED BY THREE MINUTES. NO FRAGMENTS WERE GENERATED. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19014366 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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