Chromic Gut GG-123Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521054905), received between May 3, 2016 and Sep 23, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 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.

Recalls naming this device

1. Mar 1, 2023Class IIOpen, Classified

   Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.

   Z-1388-2023 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionSep 23, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE SUTURING, THE NEEDLE BROKE AND FELL INTO THE PATIENT'S CAVITY. IT WAS SUCCESSFULLY RETRIEVED USING A GRASPER. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20280972 ↗
• InjuryDec 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON AN OPEN CAESARIAN SECTION, DURING CLOSURE, THE NEEDLE POPPED OFF THE SUTURE. THE NEEDLE FELL INTO THE CAVITY. X-RAY WAS REQUIRED TO FIND AND REMOVE THE NEEDLE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 15971721 ↗
• MalfunctionOct 17, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING CLOSURE OF A TONSILLECTOMY, THE SURGEON WAS TRYING A KNOT WHEN THE THREAD BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9202989 ↗
• MalfunctionAug 7, 2018Break

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION, WHILE ON RUNNING CLOSURE THE NEEDLE BROKE. THE COMPONENT DID NOT FALL INTO PATIENT CAVITY. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7756452 ↗
• MalfunctionSep 29, 2017Break; Break

  ACCORDING TO THE REPORTER, WHILE USING AN INTERRUPTED V-20 NEEDLE SUTURING TECHNIQUE IN AN OPEN HYSTERECTOMY PROCEDURE, THE NEEDLE BROKE DURING CLOSING. THEY HAD TO OPEN AN ADDITIONAL GUT SUTURE TO CLOSE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6903888 ↗
• InjuryMay 3, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  ACCORDING TO THE REPORTER: PATIENT HAD A VASECTOMY. DETAILS COULD NOT BE PROVIDED AT THE TIME OF THE CALL WITH THE ACCOUNT BUT THE PATIENT HAD TO RETURN TO THE OFFICE TO GET THE SUTURE REMOVED. IT WAS ESTIMATED THAT THE ORIGINAL PROCEDURE HAD TO HAVE TAKEN PLACE WITHIN A FEW WEEKS OF THE REMOVAL. THE ACCOUNTS EXPECTATION OF THE DEVICE AND WHAT IS TOLD TO PATIENTS IS THAT THE SUTURE IS DISSOLVED IN 7 TO 10 DAYS.

  Patient problems: No Code Available

  MAUDE report 5628095 ↗

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-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)