Chromic GutRecalls & reported problems across all models
Covidien LP · 33 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Chromic Gut model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 103
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 2
We found 33 models of Chromic Gut by Covidien LP in the FDA's device registry (GUDID). Together they are named in 103 adverse event reports in the FDA's MAUDE database, received between May 3, 2016 and Sep 21, 2026 — classified as 10 injuries, 93 malfunctions.
The most frequently reported specific device problem is “Break” (63 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Chromic Gut recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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-1389-2023 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- 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 · names 10 of these models · Recall details · FDA record ↗
Most reported Chromic Gut problems
Device problems
- Break63
- Detachment of Device or Device Component38
- Unraveled Material6
- Material Frayed5
- Material Twisted/Bent5
- Adverse Event Without Identified Device or Use Problem2
- Difficult to Remove2
- Knotted2
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- No Consequences Or Impact To Patient22
- No Known Impact Or Consequence To Patient22
- Insufficient Information10
- Foreign Body In Patient4
- No Code Available4
- Unintended Radiation Exposure4
- Unspecified Tissue Injury4
Chromic Gut models
33 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Chromic Gut GG-122SUTURE, ABSORBABLE, NATURAL1 recall12 reports
- Chromic Gut G-1780KSUTURE, ABSORBABLE, NATURAL1 recall8 reports
- Chromic Gut UG-202SUTURE, ABSORBABLE, NATURAL1 recall7 reports
- Chromic Gut GG-123SUTURE, ABSORBABLE, NATURAL1 recall6 reports
- Chromic Gut SG-5687GSUTURE, ABSORBABLE, NATURAL1 recall6 reports
- Chromic Gut UG-203SUTURE, ABSORBABLE, NATURAL1 recall6 reports
- Chromic Gut GG-121SUTURE, ABSORBABLE, NATURAL1 recall3 reports
- Chromic Gut GG-127SUTURE, ABSORBABLE, NATURAL1 recall3 reports
- Chromic Gut CG-904SUTURE, ABSORBABLE, NATURAL1 recall0 reports
- Chromic Gut CG-915SUTURE, ABSORBABLE, NATURAL1 recall0 reports
- Chromic Gut G-1766KSUTURE, ABSORBABLE, NATURAL1 recall0 reports
- Chromic Gut SG-5637SUTURE, ABSORBABLE, NATURAL1 recall0 reports
- Chromic Gut SG-5644GSUTURE, ABSORBABLE, NATURAL11 reports
- Chromic Gut CG-905SUTURE, ABSORBABLE, NATURAL6 reports
- Chromic Gut CG-811SUTURE, ABSORBABLE, NATURAL4 reports
- Chromic Gut SG-5687SUTURE, ABSORBABLE, NATURAL4 reports
- Chromic Gut SG-635SUTURE, ABSORBABLE, NATURAL4 reports
- Chromic Gut CG-923SUTURE, ABSORBABLE, NATURAL3 reports
- Chromic Gut GG-181SUTURE, ABSORBABLE, NATURAL3 reports
- Chromic Gut SG-634SUTURE, ABSORBABLE, NATURAL2 reports
- Chromic Gut SG-675SUTURE, ABSORBABLE, NATURAL2 reports
- Chromic Gut UG-204SUTURE, ABSORBABLE, NATURAL2 reports
- Chromic Gut CG-866SUTURE, ABSORBABLE, NATURAL1 report
- Chromic Gut CG-924SUTURE, ABSORBABLE, NATURAL1 report
- Chromic Gut CG-925SUTURE, ABSORBABLE, NATURAL1 report
- Chromic Gut G-2745KSUTURE, ABSORBABLE, NATURAL1 report
- Chromic Gut G-2797KSUTURE, ABSORBABLE, NATURAL1 report
- Chromic Gut GG-129SUTURE, ABSORBABLE, NATURAL1 report
- Chromic Gut LG-111SUTURE, ABSORBABLE, NATURAL1 report
- Chromic Gut LG-112SUTURE, ABSORBABLE, NATURAL1 report
- Chromic Gut SG-535SUTURE, ABSORBABLE, NATURAL1 report
- Chromic Gut SG-5637GSUTURE, ABSORBABLE, NATURAL1 report
- Chromic Gut SG-636SUTURE, ABSORBABLE, NATURAL1 report
Recent Chromic Gut adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847113 ↗MalfunctionApr 2, 2026Break; Material Frayed
IT WAS REPORTED THAT DURING A VAGINAL DELIVERY REPAIR, THE FIRST SUTURE STRAND WAS OBSERVED TO BE KNOTTED UPON REMOVAL FROM THE PACKAGE. THE SECOND SUTURE STRAND FRAYED AND WAS COMING APART AT/NEAR THE NEEDLE-TO-SUTURE CONNECTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24768486 ↗MalfunctionNov 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A MOLE SURGERY, THE NEEDLE SNAPPED FROM THE SUTURE. ANOTHER BRAND OF SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23544248 ↗MalfunctionNov 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A MOLE SURGERY, THE NEEDLE SNAPPED FROM THE SUTURE. ANOTHER BRAND OF SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23534704 ↗MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING THE MOLE SURGERY, THE NEEDLE SNAPPED FROM THE SUTURE THREE TIMES. ANOTHER BRAND OF SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23486758 ↗MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING THE MOLE SURGERY, THE NEEDLE SNAPPED FROM THE SUTURE THREE TIMES. ANOTHER BRAND OF SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23486630 ↗MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE NEEDLE SNAPPED FROM THE SUTURE THREE TIMES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23486590 ↗MalfunctionOct 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE THREE SUTURES EXPERIENCED NEEDLE DETACHMENT. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23375619 ↗MalfunctionOct 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THREE SUTURES EXPERIENCED NEEDLE DETACHMENT. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23375596 ↗MalfunctionOct 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE THREE SUTURES EXPERIENCED NEEDLE DETACHMENT. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23375587 ↗MalfunctionMay 5, 2025Break; Break
ACCORDING TO THE REPORTER DURING AN OPEN CESAREAN PROCEDURE, THE SUTURE STRAND BROKE WHILE SUTURING. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21958774 ↗MalfunctionMay 5, 2025Break; Break
IT WAS REPORTED THAT DURING THE CESAREAN SECTION, THE SUTURE BROKE WHILE SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21958666 ↗MalfunctionMay 2, 2025Break; Break
IT WAS REPORTED THAT DURING A C-SECTION PROCEDURE, A NEEDLE BROKE WHEN BEING PLACED INTO THE NEEDLE HOLDER. THE ISSUE OCCURRED POST-USE WHEN THE NEEDLE WAS BEING PUT IN THE NEEDLE HOLDER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21953081 ↗MalfunctionSep 23, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE SUTURING, THE NEEDLE BROKE AND FELL INTO THE PATIENT'S CAVITY. IT WAS SUCCESSFULLY RETRIEVED USING A GRASPER. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20280972 ↗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 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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