Chromic Gut SG-5687Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521055766), received between Nov 30, 2017 and Apr 19, 2022 — classified as 4 malfunctions.

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

• MalfunctionApr 19, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A BREAST REDUCTION, FOUR SUTURES BROKE.

  Patient problems: Insufficient Information

  MAUDE report 14145769 ↗
• MalfunctionMar 6, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SUTURE PACKAGING WAS OPENED, AND GRASPED WITH A NEEDLE HOLDER. THE SUTURE WAS THEN REMOVED FROM PACKAGING AND STRETCHED SLIGHTLY TO REMOVE SUTURE MEMORY. THIS IS WHEN THE SUTURE SNAPPED AT THE NEEDLE SWAGE. "3WAS" TRIED FROM THE SAME BOX, WITH THE SAME RESULT. A DIFFERENT BOX, WITH THE SAME LOT NUMBER WAS TRIED AND THE SAME THING HAPPENED. THERE WAS NO PATIENT HARM CAUSED. CURRENT PATIENT STATUS IS ALIVE WITH NO INJURY. THE PRODUCT WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7316185 ↗
• MalfunctionFeb 14, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE THREAD BROKE, ALSO THE NEEDLE WAS SNAPPED OFF AT THE SWAGE. NEW DEVICE WITH THE SAME LOT NUMBER WAS USED IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7271149 ↗
• MalfunctionNov 30, 2017Break; Material Frayed; Knotted; Break; Material Frayed; Knotted

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE WAS BREAKING OFF FROM THE THREAD, THE SUTURE WAS FRAYING, AND IT WAS COMING OUT OF THE PACK WITH KNOTS IN IT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7073487 ↗

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)