Chromic Gut CG-923Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521054080), received between Jan 16, 2019 and Apr 26, 2022 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A NATURAL BIRTH DELIVERY, WHILE DOING EPISIORRHAPHY, THE THREAD BROKE WHEN KNOTTING. THE SURGEON CONTINUED WITH ANOTHER SUTURE OF THE SAME BRAND AND LOT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14209701 ↗
• MalfunctionDec 27, 2019Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING EPISIOTOMY, THE DEVICE WAS DIFFICULT TO HANDLE AND THERE HAS BEEN AN INCREASE IN THE DEHISCENCE OF THE RAFFIA. IN ADDITION, THE EDGE WAS QUICKLY LOSING AND THE NEEDLE SUTURE WAS LOOSENING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9523521 ↗
• MalfunctionJan 16, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A VAGINAL REPAIR, AT THE END OF THE PROCEDURE, THE THREAD BROKE WHILE TYING KNOTS. ANOTHER SUTURE WAS OPENED AND THE CLOSURE WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8252612 ↗

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