SynetureRecalls & reported problems across all models
Covidien LP · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Syneture model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 1
We found 12 models of Syneture by Covidien LP in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Apr 25, 2018 and Aug 6, 2025 — classified as 7 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Break” (11 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
Syneture 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.
- Jun 24, 2026Open, Classified
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Z-2919-2026 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported Syneture problems
Device problems
- Break11
- Detachment of Device or Device Component9
- Adverse Event Without Identified Device or Use Problem2
- Labelling, Instructions for Use or Training Problem2
- Patient-Device Incompatibility2
- Unraveled Material2
- Detachment Of Device Component1
- Device Markings/Labelling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Insufficient Information3
- Tissue Breakdown3
- Unspecified Tissue Injury3
- No Consequences Or Impact To Patient2
- Wound Dehiscence2
- Bowel Perforation1
- No Code Available1
Syneture models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Syneture VLOCL2246SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall0 reports
- Syneture VLOCN0346SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE10 reports
- Syneture VLOCN2146SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE5 reports
- Syneture VLOCL2216SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Syneture VLOCN2105SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- Syneture US1560Suture kit1 report
- Syneture US1667Suture kit1 report
- Syneture US1696Suture kit1 report
- Syneture US1716Suture kit1 report
- Syneture VLOCN0345SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Syneture VLOCN2145SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Syneture VLOCN0347SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
Recent Syneture adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE LAPAROSCOPIC GASTRIC BYPASS, WHEN SUTURING, THE SUTURE BROKE AT THE WELD WITH THE FIRST PASS, DESPITE THERE BEING NO TENSION ON IT WHEN IT BROKE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22731511 ↗MalfunctionMay 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATAL HERNIA WITH GASTRIC BYPASS PROCEDURE, WHILE CLOSING THE MESENTERIC DEFECT, THE NEEDLE DETACHED AND FELL INTO THE PATIENT¿S ABDOMINAL CAVITY. IT WAS RETRIEVED USING GRASPERS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22079700 ↗MalfunctionJan 23, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21219583 ↗MalfunctionJan 10, 2025Break; Break
IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC HYSTERECTOMY, THE VLOC DEVICE BROKE WHILE BEING APPLIED TO THE CLOSING OF THE VAGINAL CUFF.
Patient problems: Insufficient Information
MAUDE report 21123525 ↗MalfunctionJan 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT DURING A HYSTERECTOMY PROCEDURE, THE PATIENT EXPERIENCED VAGINAL CUFF CELLULITIS AND WAS TREATED FOR THIS CONDITION.
Patient problems: Tissue Breakdown; Unspecified Tissue Injury
MAUDE report 21085175 ↗InjurySep 20, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE REPORTER, POST-OPERATIVE A CRUROPLASTY FUNDOPLICATION PERFORMED LAST APRIL, THE PATIENT WAS RE-ADMITTED INTO THE HOSPITAL BECAUSE THE PATIENT HAD A NARROWING OF THE ESOPHAGUS AND SCAR TISSUE FORMATION AROUND THE SUTURE.
Patient problems: Scar Tissue
MAUDE report 20274626 ↗MalfunctionSep 5, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING THE VAGINAL CUFF, THE THREE SUTURE WAS BROKEN. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20146276 ↗MalfunctionSep 5, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING THE VAGINAL CUFF, THE THREE SUTURE WAS BROKEN. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20146221 ↗MalfunctionSep 5, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING THE VAGINAL CUFF, THE THREE SUTURE WAS BROKEN. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20146053 ↗MalfunctionJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC HERNIA REPAIR, WHEN INSERTING 4 SUTURE STRANDS THROUGH A TROCAR IN THE ABDOMINAL CAVITY, THE NEEDLE DETACHED. THE NEEDLE FELL INTO THE CAVITY BUT WAS REPORTED TO BE RETRIEVED AND DISCOVERED WITH A LAPAROSCOPIC SCOPE. SURGICAL TIME WAS EXTENDED BY 10 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19625834 ↗MalfunctionJun 25, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A ROBOTIC VENTRAL HERNIA REPAIR, WHEN CLOSING THE ABDOMINAL WALL, THE SUTURE STRAND BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19610388 ↗InjuryFeb 2, 2024Break; Break
ACCORDING TO THE REPORTER, POSTOPERATIVELY OF ROBOTIC LAPAROSCOPIC UMBILICAL HERNIA, THE NURSE EXTUBATED THE PATIENT. AFTERWARD, THE PATIENT COUGHED, WHICH IS NORMAL, AND THE FIRST ASSISTANT NOTICED SOMETHING POPPED. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM (OR) AND NOTICED THAT THE SUTURE HAD POPPED. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE. THE SUTURE WAS REPLACED WITH A LONGER STRAND TO RESOLVE THE ISSUE.
Patient problems: Tissue Breakdown
MAUDE report 18628988 ↗InjuryJan 9, 2024Break; Unraveled Material; Break; Unraveled Material
ACCORDING TO THE REPORTER, POSTOPERATIVELY, FOLLOWING AN OPEN ABDOMINAL PROCEDURE TO REMOVE A LARGE OVARIAN MASS, THE PATIENT RETURNED TO THE EMERGENCY ROOM WITH HER SMALL BOWEL EXPOSED BECAUSE THE SUTURE DID NOT HOLD. IT WAS NOTED THAT THE SUTURE WAS BROKEN. TO RESOLVE THE ISSUE, ADDITIONAL SURGERY WAS PERFORMED TO CLOSE THE WOUND.
Patient problems: Bowel Perforation; Wound Dehiscence
MAUDE report 18480962 ↗MalfunctionOct 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATAL HERNIA REPAIR PROCEDURE, WHEN INSERTING THE STRAND THROUGH THE METALLIC TROCAR, THE NEEDLE AND STRAND SEPARATED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18044654 ↗InjurySep 15, 2023Break; Material Frayed; Unraveled Material; Break; Material Frayed; Unraveled Material
ACCORDING TO THE REPORTER, POST-OPERATIVE TO AN OPEN EPIGASTRIC HERNIA AND UMBILICAL HERNIA REPAIR, PATIENT WAS RETURNED TO THE HOSPITAL FOR REOPERATION THE NEXT DAY AS AN EMERGENCY DUE TO WOUND DEHISCENCE. IN OPERATING ROOM AT THE RE-EXPLORATION, THE SUTURE LAYER WAS FOUND TO BE FRAGMENTED INTO MULTIPLE PIECES ALONG THE ENTIRE LENGTH OF THE WOUND INVOLVING BOTH SUTURES. NO TISSUE CUT THROUGH OF THE SUTURE WAS EVIDENT. THE SUTURE FRAGMENTS WERE REMOVED, AND TWO LENGTHS OF SUTURE WERE USED FOR EACH HALF OF THE DEFECT TO CLOSE THE LINEA ALBA AFTER A VENTRAL INCISIONAL HERNIA REPAIR OVER A NARROW MESH PATCH. THE INCISION WAS EXTENDED MORE THAN 1 INCH. THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.
Patient problems: Tissue Breakdown; Wound Dehiscence
MAUDE report 17760604 ↗
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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