Chromic Gut SG-5687GRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521055773), received between Sep 2, 2020 and Feb 15, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• MalfunctionFeb 15, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LEFT FINGER AMPUTATION, WHILE THE SURGEON WAS USING THE SUTURE, THE NEEDLE BROKE. A NEW SUTURE AND NEEDLE WERE USED TO RESOLVE THE ISSUE, THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378817 ↗
• InjuryJun 22, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LACERATION REPAIR PROCEDURE WITHOUT SEDATION, WHILE SUTURING A NAIL BED LACERATION, THE NEEDLE BROKE. ABOUT 2/3 OF THE NEEDLE RETAINED WITHIN THE PATIENT'S THUMB AND COULD NOT BE REMOVED. THE PATIENT REQUIRED IV SEDATION WITHIN THE ED (EMERGENCY DEPARTMENT) AND PLASTIC SURGERY WAS DONE TO SUCCESSFULLY REMOVE THE BROKEN FRAGMENT AND COMPLETE THE PROCEDURE. CURRENTLY THE PATIENT IS DISCHARGED HOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14777325 ↗
• InjuryJun 8, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LACERATION REPAIR, ON THE SKIN, THERE WAS A RETAINED FRAGMENT OF THE NEEDLE THAT BROKE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. AN X-RAY WAS PERFORMED FOR THE EXPRESS PURPOSE OF LOCATING THE NEEDLE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 14635429 ↗
• MalfunctionSep 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SKIN CLOSURE ON A BREAST RECONSTRUCTION PROCEDURE, WHILE THE SURGEON WAS PERFORMING AN INTERUPTED STITCH, THE NEEDLE CAME OFF THE THREAD LIKE A POP OFF NEEDLE WOULD EVEN THOUGH IT IS NOT. A NEW SUTURE PACK WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10532115 ↗
• MalfunctionSep 2, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING THE CLOSING OF INCISION ON AN OPEN BREAST RECONSTRUCTION, THREE DEVICES FROM THE SAME PACKAGE HAD ISSUES WHEN BEING PASSED THROUGH THE SKIN. IT WAS STATED THAT ONE HAD A BENT AND BROKEN NEEDLE WHILE THE OTHER TWO HAD BROKEN SUTURES. ADDITIONAL SUTURE FROM A NEW PACKAGE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10482827 ↗
• MalfunctionSep 2, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING THE CLOSING OF INCISION ON AN OPEN BREAST RECONSTRUCTION, THREE DEVICES FROM THE SAME PACKAGE HAD ISSUES WHEN BEING PASSED THROUGH THE SKIN. IT WAS STATED THAT ONE HAD A BENT AND BROKEN NEEDLE WHILE THE OTHER TWO HAD BROKEN SUTURES. ADDITIONAL SUTURE FROM A NEW PACKAGE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10482782 ↗

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-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)