Chromic Gut UG-203Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521056145), received between Nov 30, 2017 and Dec 29, 2023 — classified as 6 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 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE AND THREAD WERE NOT PROPERLY ASSEMBLED; THE THREAD CAME LOOSE EASILY AND WAS BROKEN. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE, BUT IT WAS STILL THE SAME.

  Patient problems: Insufficient Information

  MAUDE report 18420608 ↗
• MalfunctionJun 22, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE THREAD HAD BROKEN. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 17186858 ↗
• MalfunctionMay 12, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING THE SEPTOPLASTY, TURBINOPLAST INFERIOR BILATERAL PROCEDURE, WHILE BEING APPLIED AT THE SEPTUM FOR TISSUE CLOSING, THE FOUR NEEDLES BENT AND BROKE. TO RESOLVE THE ISSUE, THE SURGEON HAD TO CHANGE THE SUTURE FIVE TIMES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14377871 ↗
• MalfunctionJan 21, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN PROCEDURE, THE THREAD BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9610254 ↗
• MalfunctionAug 5, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A OTORHINOLARYNGOLOGY OPEN PROCEDURE, WHILE SUTURING THE TISSUE, THE ABSORBABLE SUTURE NEEDLE WAS BROKEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8862626 ↗
• MalfunctionNov 30, 2017Material Frayed; Knotted; Detachment of Device or Device Component; Material Frayed; Knotted; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY IN ENT PROCEDURES THEY MENTIONED SEPTOPLASTIES, THE SURGEON FINDS THAT THE NEEDLE KEEPS BREAKING OFF FROM THE THREAD, THE SUTURE IS FRAYING, AND IT IS COMING OUT OF THE PACK WITH KNOTS IN IT. FIVE UNOPENED SUTURES WILL BE RETURNED FOR ANALYSIS BUT THE REP IS UNSURE IF THEY ARE ALL FROM THE SAME LOT NUMBER THAT HAS THE ISSUE. THE ACCOUNT HAS NOT PROVIDED ANY MORE INFORMATION OTHER THAN THAT IT HAS HAPPENED IN NUMEROUS CASES AND DO NOT HAVE ONE SPECIFIC PATIENT EVENT. NO PATIENT DETAILS ARE LISTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7073907 ↗

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)