Plain Gut CG-172Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884521053581), received between Feb 16, 2021 and Feb 16, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, DURING SKIN CLOSURE IN A MOHS PROCEDURE, SUTURE CAUSED TEMPORARY SKIN REACTION ON PATIENT TISSUE. SURGEON REPLACED WITH COMPETITOR'S SUTURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11333344 ↗
• InjuryFeb 16, 2021Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, SUTURES WERE NOT ABSORBING AND CAUSED INFECTIONS. SUTURES THAT HAVE BEEN IN PLACE FOR OVER A MONTH HAVE BEEN TAKEN OUT WHEN THEY WERE SUPPOSED TO DISSOLVE IN ABOUT 2 WEEKS.

  Patient problems: Unspecified Infection

  MAUDE report 11331569 ↗
• InjuryFeb 16, 2021Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, SUTURES WERE NOT ABSORBING AND CAUSED INFECTIONS. SUTURES THAT HAVE BEEN IN PLACE FOR OVER A MONTH HAVE BEEN TAKEN OUT WHEN THEY WERE SUPPOSED TO DISSOLVE IN ABOUT 2 WEEKS.

  Patient problems: Foreign Body Reaction; Post Operative Wound Infection; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11331564 ↗

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-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)
• 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