Plain GutRecalls & reported problems across all models
Covidien LP · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Plain Gut model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 1
We found 13 models of Plain Gut by Covidien LP in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Sep 12, 2017 and Sep 24, 2026 — classified as 9 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (15 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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
Plain 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-1390-2023 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
Most reported Plain Gut problems
Device problems
- Patient-Device Incompatibility15
- Break12
- Detachment of Device or Device Component6
- Adverse Event Without Identified Device or Use Problem2
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Code Available7
- Insufficient Information5
- Skin Inflammation5
- Skin Irritation5
- Unspecified Infection3
- Inflammation2
- No Known Impact Or Consequence To Patient2
Plain Gut models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Plain Gut SG-5686SUTURE, ABSORBABLE, NATURAL1 recall6 reports
- Plain Gut SG828-2SUTURE, ABSORBABLE, NATURAL1 recall1 report
- Plain Gut G-1735-KSUTURE, ABSORBABLE, NATURAL7 reports
- Plain Gut CG-172SUTURE, ABSORBABLE, NATURAL3 reports
- Plain Gut SG-752SUTURE, ABSORBABLE, NATURAL3 reports
- Plain Gut G-1774-KSUTURE, ABSORBABLE, NATURAL2 reports
- Plain Gut SG-5696SUTURE, ABSORBABLE, NATURAL2 reports
- Plain Gut SG604-2SUTURE, ABSORBABLE, NATURAL2 reports
- Plain Gut CG-842SUTURE, ABSORBABLE, NATURAL1 report
- Plain Gut CG-872SUTURE, ABSORBABLE, NATURAL1 report
- Plain Gut G-1770-KSUTURE, ABSORBABLE, NATURAL1 report
- Plain Gut SG-821SUTURE, ABSORBABLE, NATURAL1 report
- Plain Gut SG-828SUTURE, ABSORBABLE, NATURAL1 report
Recent Plain Gut adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Detachment of Device or Device Component
It was reported that during functionally endoscopic sinus surgery with septoplasty, the needle detached from the suture while reapproximating septal tissue. An additional new suture was used without issue. No patient consequences or impact were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877063 ↗MalfunctionFeb 12, 2026Break
IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUTURE BROKE WHILE SUTURING. ANOTHER SUTURE WAS OPENED TO FIX THE ISSUE. NO PATIENT C OMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24326771 ↗MalfunctionOct 23, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING, THE SUTURE BROKE AFTER 2 STITCHES. THE SUTURE WAS CHANGE TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23375488 ↗MalfunctionOct 21, 2025Break; Break
IT WAS REPORTED THAT DURING A SEPTOPLASTY AND A SKIN GRAFT ON THE HEAD, THE SUTURE BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23344954 ↗MalfunctionMay 5, 2025Break; Break
ACCORDING TO THE REPORTER DURING AN OPEN CESAREAN PROCEDURE, THE SUTURE BROKE WHILE SUTURING. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21958744 ↗MalfunctionOct 17, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE REPORTER, DURING A CARPAL TUNNEL OR TRIGGER FINGER RELEASE PROCEDURE, THE PATIENT HAD A MINOR REACTION TO THE SUTURE. THE DEVICE CAUSED RED AND RAISED AREAS, SOMETIMES BLISTERING.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 20470635 ↗MalfunctionOct 11, 2024Break; Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LIPOMA REMOVAL, DURING THE SKIN CLOSURE OR WHEN THE SURGEON HAS MADE THE KNOTS, THE SUTURE BROKE. THE ISSUE OCCURRED IN TWO SUTURES. ANOTHER KIND OF SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20426168 ↗MalfunctionOct 11, 2024Break; Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LIPOMA REMOVAL, DURING THE SKIN CLOSURE OR WHEN THE SURGEON HAS MADE THE KNOTS, THE SUTURE BROKE. THE ISSUE OCCURRED IN TWO SUTURES. ANOTHER KIND OF SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20426102 ↗MalfunctionAug 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A RETINA PROCEDURE, THE SUTURE BROKE OFF WHILE THE SURGEON WAS CLOSING.
Patient problems: Insufficient Information
MAUDE report 19970909 ↗MalfunctionAug 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A RETINA PROCEDURE, THE SUTURE BROKE OFF WHILE THE SURGEON WAS CLOSING.
Patient problems: Insufficient Information
MAUDE report 19970908 ↗MalfunctionAug 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A RETINA PROCEDURE, THE SUTURE BROKE OFF WHILE THE SURGEON WAS CLOSING.
Patient problems: Insufficient Information
MAUDE report 19970907 ↗MalfunctionAug 8, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN EYE SURGERY, THE SUTURE BROKE OFF WHILE SURGEON WAS CLOSING A RETINA.
Patient problems: Insufficient Information
MAUDE report 19943761 ↗MalfunctionJul 25, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE REPORTER, 12 WEEKS AFTER THE INITIAL SURGERY, IT WAS ALL COMPLETELY INTACT, BUT ONE OF THEM WAS CAUSING THE PATIENT PAIN, DISCHARGE, AND REDNESS ON THE EYE.
Patient problems: Eye Pain; Fluid Discharge; Hypersensitivity/Allergic reaction
MAUDE report 19833953 ↗MalfunctionJul 3, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE REPORTER, THE KNOT FROM THE GUT SUTURE WAS NOT ABSORBING 3 MONTHS FROM THE ORIGINAL VITRECTOMY. THE SURGEON TOOK OUT THE SUTURE IN HIS OFFICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17246535 ↗MalfunctionJun 30, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE REPORTER, FOLLOWING AN OPEN VITRECTOMY SURGERY, THE PATIENT WAS EXPERIENCING INFLAMMATION IN THE EYE AND THE KNOT FROM THE GUT SUTURE IS STILL IN THEIR EYE OVER THREE MONTHS LATER. THE PATIENT WAS MORE LIKELY TO BE BROUGHT BACK IN THE OPERATING ROOM TO RESOLVE THE ISSUE.
Patient problems: Inflammation
MAUDE report 17244059 ↗
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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