Chromic Gut GG-122Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521054899), received between Oct 23, 2017 and Jul 23, 2024 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CIRCUMCISION, WHEN THE SURGEON WENT TO TIE THE SUTURE, THE THREAD BROKE IN THE MIDDLE WHILE TYING, AND WHEN THE SCRUB TECH PLACED IT IN THE NEEDLE HOLDER, THE NEEDLE PULLED AWAY FROM THE SUTURE. THE SAME ISSUE OCCURRED WITH THE SECOND SUTURE DURING THE SAME CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19812181 ↗
• MalfunctionJul 23, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CIRCUMCISION, WHEN THE SURGEON WENT TO TIE THE SUTURE, THE THREAD BROKE IN THE MIDDLE WHILE TYING, AND WHEN THE SCRUB TECH PLACED IT IN THE NEEDLE HOLDER, THE NEEDLE PULLED AWAY FROM THE SUTURE. THE SAME ISSUE OCCURRED WITH THE SECOND SUTURE DURING THE SAME CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19811834 ↗
• InjuryOct 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE DETACHED FROM THE SUTURE THREAD WHILE ON NORMAL USE OF SUTURING LACERATIONS. THE NEEDLE WAS LOST IN THE VAGINAL TISSUE DURING ROUTINE CLOSURE OF LACERATION AFTER BIRTH. AN X-RAY WAS TAKEN AND A COMPUTED TOMOGRAPHY (CT) SCAN SHOWING NEEDLE POSITIONED DIRECTLY POSTERIOR TO THE DISTAL RECTUM. THE NEEDLE WAS NOT RETRIEVED. DECISION MADE BY OBSTETRICIAN (OB) AND SURGEON TO LEAVE THE NEEDLE AS THE RISK OF RETRIEVAL OUTWEIGHED THE BENEFIT.

  Patient problems: Foreign Body In Patient; Laceration(s); Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 15703247 ↗
• InjuryOct 27, 2022Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING ROUTINE CLOSURE OF LACERATION AFTER BIRTH, THE NEEDLE DETACHED FROM THE SUTURE THREAD ON NORMAL USE WHILE SUTURING THE LACERATION. THE NEEDLE WAS LOST IN THE VAGINAL TISSUE. IT WAS NOT ABLE TO BE PALPATED WHERE THE NEEDLE WAS INSERTED AT. ATTEMPTED TO LOCATE THE NEEDLE BUT WAS UNABLE TO AFTER A FEW MINUTES. A STAFF NOTIFIED AN ON CALL DOCTOR AND ORDERED AN X-RAY TO VERIFY THE NEEDLE LOCATION. THE ON-CALL DOCTOR CAME TO THE UNIT AND ATTEMPTED TO LOCATE THE NEEDLE WITHOUT SUCCESS. ANOTHER DOCTOR CAME TO THE UNIT AND ATTEMPTED TO LOCATE THE NEEDLE. MORE IMAGING STUDIES WERE COMPLETED BETWEEN THE TWO DOCTORS TO TRY TO GET A CLEARER PICTURE OF LOCATION. AFTER A TOTAL OF APPROXIMATELY 4 HOURS BETWEEN THE THREE PROVIDERS, SPOKE TO ANOTHER DOCTOR ABOUT THE CASE. A COMPUTERIZED TOMOGRAPHY (CT) WAS ORDERED AND WAS ADVISED THAT THE NEEDLE BE LEFT IN PLACE RATHER THAN TAKE THE PATIENT BACK TO SURGERY TO HAVE IT REMOVED. THE PATIENT AGREED TO THE PLAN.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 15684848 ↗
• MalfunctionMar 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CLOSURE IN AN OPEN PROCEDURE, SURGEON STATED THAT THE THREAD MAY NOT BE AS SECURE AT THE SWAGE BECAUSE THE NEEDLE SORT OF JUST POPPED OFF DURING USE. SURGEON USED ANOTHER SUTURE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13756214 ↗
• MalfunctionMar 3, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING ANOSCOPY, WHEN CLAMPING HEMORRHOID, TWO THREADS BROKE. ANOTHER SUTURE WAS USED 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 11404339 ↗
• MalfunctionJan 18, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING DILATION AND CURETTAGE PROCEDURE, WHILE CLOSING, THE THREAD BROKE DURING KNOT TYING. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11189527 ↗
• MalfunctionAug 19, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, 7 DAYS POSTOPERATIVE FROM A CIRCUMCISION, THE SUTURE APPEARED TO FALL/BREAK APART TOO SOON. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8907204 ↗
• 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 8398548 ↗
• MalfunctionJan 15, 2019Break; Break

  ACCORDING TO THE REPORTER DURING AN EXTIRPATION OF THE VEINS, WHEN TYING THE VEIN, BY FASTENING THE GLASSES AND ANCHORING WITHOUT TESTING THE STRENGTH OR TENSION, BY THE SPECIALIST, BOTH OF THE THREAD BROKE IN TWO. A THIRD SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8251461 ↗
• MalfunctionJul 26, 2018Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC OPEN PROCEDURE, WHILE SUTURING, THE NEEDLE DETACHED FROM THE STRAND. THEY OPENED A NEW SUTURE 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 7723477 ↗
• MalfunctionOct 23, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN RADICAL PROSTATECTOMY PROCEDURE, THE THREAD BROKE AND FELL INTO THE CAVITY OF THE PATIENT. THE INCISION WAS EXTENDED DUE TO THE PRODUCT PROBLEM. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6968383 ↗

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)