Chromic Gut CG-811Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521053762), received between Dec 16, 2019 and Apr 2, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Break; Material Frayed

  IT WAS REPORTED THAT DURING A VAGINAL DELIVERY REPAIR, THE FIRST SUTURE STRAND WAS OBSERVED TO BE KNOTTED UPON REMOVAL FROM THE PACKAGE. THE SECOND SUTURE STRAND FRAYED AND WAS COMING APART AT/NEAR THE NEEDLE-TO-SUTURE CONNECTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24768486 ↗
• InjuryJun 21, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A FEMORAL ARTERY BYPASS PROCEDURE, THE NEEDLE TIP BROKE. A SMALL PIECE OF TIP OF NEEDLE DID FALL INTO CAVITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19589994 ↗
• MalfunctionNov 12, 2021Break; Break

  ACCORDING TO THE REPORTER DURING A CESAREAN SECTION PROCEDURE, WHILE USING INTERRUPTED STITCH TECHNIQUE, THE THREAD BROKE. A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12805845 ↗
• MalfunctionDec 16, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION PROCEDURE , THE SUTURE THREAD WAS BROKEN. ANOTHER SUTURE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9472841 ↗

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)