Chromic Gut UG-202Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521056138), received between Apr 19, 2018 and Jun 15, 2023 — classified as 7 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 16, 2026.

Recalls naming this device

1. Mar 1, 2023Open, 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2023Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE THREAD WAS BROKEN. IN THE MIDDLE OF THE SURGICAL PROCEDURE, PASSAGE OF THE POINTS IN WHICH THE SUTURE CUTS IS CARRIED OUT, IN TWO TIMES THE SAME THING HAPPENED. A NEW DEVICE WITH SAME CHARACTERISTICS WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 17134325 ↗
• MalfunctionJul 29, 2022Use of Device Problem; Detachment of Device or Device Component; Insufficient Device Problem Information; Use of Device Problem; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, PRIOR TO THE IMPLANT OF THE 18MM AORTIC MECHANICAL VALVE, THE SUTURE LOOSENED FROM THE NEEDLE DURING MANIPULATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15129159 ↗
• MalfunctionNov 20, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING INCISION CLOSURE ON A SEPTOPLASTY AND TURBINATE REDUCTION, THE FIRST NEEDLE BROKE DURING SUTURING AND THE SECOND NEEDLE BENT ON FIRST THROW. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9348408 ↗
• MalfunctionOct 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN MAKING THE KNOTS DURING A CIRCUMCISION PROCEDURE, THE SUTURE WAS RELEASED EVEN WHEN THERE WERE NO RESISTANCE TO FROM THE KNOT. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9241138 ↗
• 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 8398551 ↗
• MalfunctionJan 10, 2019Break; Break

  ACCORDING TO THE REPORTER, WHEN THE SURGEON PASSES THE FIRST POINT OF SUTURE THROUGH THE TISSUE ON A CIRCUMCISION PROCEDURE, BOTH NEEDLE AND THREAD BROKE. A NEW SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8236124 ↗
• MalfunctionApr 19, 2018Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE DEVICE WAS OPENED AND BEING PREPARED, THE THREAD BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7443171 ↗

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)