Plain Gut G-1735-KRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521054264), received between Jun 30, 2023 and Aug 13, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A RETINA PROCEDURE, THE SUTURE BROKE OFF WHILE THE SURGEON WAS CLOSING.

  Patient problems: Insufficient Information

  MAUDE report 19970909 ↗
• MalfunctionAug 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A RETINA PROCEDURE, THE SUTURE BROKE OFF WHILE THE SURGEON WAS CLOSING.

  Patient problems: Insufficient Information

  MAUDE report 19970908 ↗
• MalfunctionAug 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A RETINA PROCEDURE, THE SUTURE BROKE OFF WHILE THE SURGEON WAS CLOSING.

  Patient problems: Insufficient Information

  MAUDE report 19970907 ↗
• MalfunctionAug 8, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN EYE SURGERY, THE SUTURE BROKE OFF WHILE SURGEON WAS CLOSING A RETINA.

  Patient problems: Insufficient Information

  MAUDE report 19943761 ↗
• MalfunctionJul 3, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, THE KNOT FROM THE GUT SUTURE WAS NOT ABSORBING 3 MONTHS FROM THE ORIGINAL VITRECTOMY. THE SURGEON TOOK OUT THE SUTURE IN HIS OFFICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17246535 ↗
• MalfunctionJun 30, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, FOLLOWING AN OPEN VITRECTOMY SURGERY, THE PATIENT WAS EXPERIENCING INFLAMMATION IN THE EYE AND THE KNOT FROM THE GUT SUTURE IS STILL IN THEIR EYE OVER THREE MONTHS LATER. THE PATIENT WAS MORE LIKELY TO BE BROUGHT BACK IN THE OPERATING ROOM TO RESOLVE THE ISSUE.

  Patient problems: Inflammation

  MAUDE report 17244059 ↗
• MalfunctionJun 30, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, FOLLOWING AN OPEN VITRECTOMY SURGERY, THE PATIENT WAS EXPERIENCING INFLAMMATION IN THE EYE AND THE KNOT FROM THE GUT SUTURE IS STILL IN THEIR EYE OVER THREE MONTHS LATER. THE PATIENT WAS MORE LIKELY TO BE BROUGHT BACK IN THE OPERATING ROOM TO RESOLVE THE ISSUE.

  Patient problems: Inflammation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17244033 ↗

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-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)
• 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)