Chromic Gut CG-905Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521054011), received between Oct 10, 2017 and Nov 23, 2022 — classified as 1 injury, 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE SUTURES WERE OPENED, THEY WERE ALREADY DETACHED FROM THE STRANDS. ANOTHER DEVICE FROM THE SAME LOT WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15853060 ↗
• MalfunctionNov 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE SUTURES WERE OPENED, THEY WERE ALREADY DETACHED FROM THE STRANDS. ANOTHER DEVICE FROM THE SAME LOT WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852959 ↗
• InjuryJan 23, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CAESARIAN SECTION PROCEDURE, WHILE THE SURGEON PERFORMING ANCHOR STITCH ON THE LEFT UTERINE SITE, THE DEVICE NEEDLE BROKE AND THE NEEDLE TIP FELL INTO THE PATIENT CAVITY. TO RESOLVE THE ISSUE THE SURGEON PERFORMED AN X-RAY TO LOCATE THE NEEDLE BUT IT WAS NOT FOUND AND DECIDED TO LEFT THE NEEDLE TIP INSIDE THE PATIENT TO AVOID CAUSING MORE TRAUMA. THE SURGICAL TIME WAS EXTENDED FOR ABOUT 30 MINUTES, THERE WERE ALSO TISSUE DAMAGE AND THE PATIENT HAD BLOOD LOSS FOR ABOUT 650CC DUE TO THE PRODUCT PROBLEM. TO COMPLETE THE CASE THE SURGEON USED ANOTHER SUTURING DEVICE.

  Patient problems: Blood Loss; Device Embedded In Tissue or Plaque; No Code Available; Radiation Exposure, Unintended; Tissue Damage

  MAUDE report 9621228 ↗
• MalfunctionFeb 28, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN OBSTETRIC PROCEDURE, WHILE SUTURING THE UTERUS, TOWARDS THE END OF THE PROCEDURE USING A STANDARD TECHNIQUE, THE THREAD OF THE SUTURE BROKE. IT HAPPENED WITH 3 SUTURES CONSECUTIVELY ON THE SAME PATIENT. THEY USED ANOTHER SUTURE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8380209 ↗
• MalfunctionApr 24, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning

  ACCORDING TO THE REPORTER, WHEN THE SURGEON TRIED TO SUTURE THE TISSUE ON A CAESAREAN SECTION PROCEDURE, THE NEEDLE REFUSED TO PENETRATE THE TISSUE. THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7455741 ↗
• MalfunctionOct 10, 2017Break; Product Quality Problem; Mechanics Altered; Break; Product Quality Problem; Mechanics Altered

  ACCORDING TO THE REPORTER: AS PER THE ADDITIONAL INFORMATION RECEIVED, TWENTY MINUTES INTO THE PROCEDURE THE THREAD OF THE SUTURE BROKE. THE SUTURE PACKAGE WAS OPENED ABOUT TEN MINUTES PRIOR TO USE. THE SUTURE WAS NOT TREATED OR HYDRATED PRIOR TO USE. THE THREAD BROKE BEFORE THE SURGEON COULD THROW THE STITCH. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6937557 ↗

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-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
• 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)