Chromic Gut GG-121Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521054882), received between Mar 7, 2019 and Mar 21, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, UPON REMOVAL FROM THE PACKAGING THE NEEDLE DETACHED FROM THE STRAND. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956396 ↗
• MalfunctionMay 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE DEVICE'S NEEDLE POPPED OFF OF THE SUTURE. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11768948 ↗
• MalfunctionMar 7, 2019Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POSTOPERATIVE FROM A SCROTAL PROCEDURE, THE MIDLINE SCROTAL INCISION LOOKS GOOD THOUGH THE UPPER 1 -1.5 CM WOUND HAD OPENED UP. IT WAS STATED THAT IT LOOKED LIKE THE SUTURES HAVE ALREADY ABSORBED IN THIS REGION. THERE WAS NO DRAINAGE, ERYTHEMIA OR SIGNIFICANT SWELLING NOTED. A TOPICAL SKIN ADHESIVE WAS APPLIED OVER THIS UPPER PART OF THE INCISION WITH GOOD RESULTS. THE PATIENT TOLERATED THIS WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Wound Dehiscence

  MAUDE report 8398547 ↗

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)