Plain Gut G-1774-KRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521054400), received between Nov 20, 2019 and Nov 20, 2019 — classified as 1 injury, 1 malfunction.

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

• MalfunctionNov 20, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, 7 -10 DAYS POST EYELID SURGERY, THE SUTURE HAS BEEN MORE BROKEN DOWN AND WAS DIFFICULT TO REMOVE FROM PATIENT.

  Patient problems: No Information

  MAUDE report 9347128 ↗
• InjuryNov 20, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, TEN DAY POST-OPHTHALMIC SURGERY, PATIENT WAS SEEN BY SURGEON AND STATED THAT THE SUTURE DID NOT DISSOLVED IN THE EXPECTED AMOUNT OF TIME. REOPERATION WAS DONE TO RESOLVE THE ISSUE AND NOTED THAT THE SUTURE WAS DIFFICULT TO REMOVED FROM THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 9347111 ↗

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)