Chromic Gut UG-204Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521056152), received between Apr 25, 2017 and Jan 21, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K142656, K885018); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2020Break; Material Frayed; Break; Material Frayed

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE SUTURE FRAYED AND BROKE. ANOTHER REPORTED SUTURE DEVICE WAS NOTED TO BE NEEDLE BENT. SURGEON NEEDED TO OPEN ANOTHER SUTURE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9611172 ↗
• MalfunctionApr 25, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING HYDROCELE RESECTION (OPEN PROCEDURE), SUTURE BROKE. ANOTHER CHROMIC GUT WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. NO HARM/INJURY TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6519152 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142656, K885018. One submission often covers many models, so check the product and lot details in each record.

• Z-1390-2023 · Mar 1, 2023 · Open, Classified
  Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2)
• Z-1388-2023 · Mar 1, 2023 · Open, Classified
  Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (G
• Z-1389-2023 · Mar 1, 2023 · Open, Classified
  Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)