Coated VICRYLRecalls & reported problems across all models
Johnson & Johnson International Inc. · 50 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,082
- Deaths reported
- 1
- Injuries reported
- 108
- Recalls
- 0
We found 50 models of Coated VICRYL by Johnson & Johnson International Inc. in the FDA's device registry (GUDID). Together they are named in 1,082 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2017 and Sep 24, 2026 — classified as 1 death, 108 injuries, 973 malfunctions.
The most frequently reported specific device problem is “Break” (498 reports).
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
Most reported Coated VICRYL problems
Device problems
- Break498
- Material Separation460
- Adverse Event Without Identified Device or Use Problem61
- Material Integrity Problem28
- Defective Component20
- Material Frayed20
- Appropriate Device Problem Term/Code Not Available19
- Delivered as Unsterile Product12
Patient problems
- No Clinical Signs, Symptoms or Conditions741
- No Consequences Or Impact To Patient179
- Wound Dehiscence61
- Unspecified Infection30
- Impaired Healing21
- Foreign Body In Patient20
- Insufficient Information20
- Inflammation19
Coated VICRYL models
50 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Coated VICRYL J496HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID107 reports
- Coated VICRYL J370HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID106 reports
- Coated VICRYL J316HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID76 reports
- Coated VICRYL J945HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID61 reports
- Coated VICRYL J497GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID55 reports
- Coated VICRYL J339HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death48 reports
- Coated VICRYL J345HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID47 reports
- Coated VICRYL J317HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID42 reports
- Coated VICRYL J341HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID41 reports
- Coated VICRYL J359HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID41 reports
- Coated VICRYL J417HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID39 reports
- Coated VICRYL J260HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID37 reports
- Coated VICRYL J340HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID37 reports
- Coated VICRYL J946HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID35 reports
- Coated VICRYL J269HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID24 reports
- Coated VICRYL J517HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID23 reports
- Coated VICRYL J486HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID21 reports
- Coated VICRYL J333HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID18 reports
- Coated VICRYL J519HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID18 reports
- Coated VICRYL J977HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID18 reports
- Coated VICRYL J371HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID17 reports
- Coated VICRYL J497HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID17 reports
- Coated VICRYL J347HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID13 reports
- Coated VICRYL J474HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID13 reports
- Coated VICRYL J453HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID12 reports
- Coated VICRYL J587HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID11 reports
- Coated VICRYL J329HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID9 reports
- Coated VICRYL J338HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID9 reports
- Coated VICRYL J261HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID8 reports
- Coated VICRYL J344HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID8 reports
- Coated VICRYL J322HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID7 reports
- Coated VICRYL J335HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID7 reports
- Coated VICRYL J267HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID6 reports
- Coated VICRYL J958HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID6 reports
- Coated VICRYL J978HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID6 reports
- Coated VICRYL J364HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID5 reports
- Coated VICRYL J418HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID5 reports
- Coated VICRYL J363HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID4 reports
- Coated VICRYL J232HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Coated VICRYL J352HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Coated VICRYL J460HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Coated VICRYL J468HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Coated VICRYL J518HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Coated VICRYL J944HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Coated VICRYL J467HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Coated VICRYL J306HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Coated VICRYL J323HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Coated VICRYL J365HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Coated VICRYL J461HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Coated VICRYL J586HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
Recent Coated VICRYL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Break
It was reported that a patient underwent a C-Section procedure on (b)(6)2026 and suture was used. During the surgery, the suture was broken when the uterus was sutured. The surgeon immediately clamped the broken tail end with vascular forceps to prevent uterine bleeding and immediately replaced a new suture for suture. The surgery progressed smoothly. No adverse patient consequences were reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889846 ↗MalfunctionSep 2, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569814 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50544394 ↗MalfunctionAug 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50410611 ↗MalfunctionAug 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50409743 ↗MalfunctionAug 6, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50158625 ↗InjuryAug 3, 2026Break
Patient problems: Foreign Body In Patient; Pain
MAUDE report 50123750 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. One to two months later the patient experienced a wound complication/infection. Product was not available for return and testing. Additional information was requested.
Patient problems: Unspecified Infection
MAUDE report 50089797 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. One to two months later the patient experienced a wound complication/infection. Product was not available for return and testing. Additional information was requested.
Patient problems: Unspecified Infection
MAUDE report 50089789 ↗MalfunctionJun 16, 2026Break; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, BOTH SUTURES WERE TANGLED, FRAYED AND EASILY BROKEN. THEY WERE NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25523320 ↗MalfunctionMay 27, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE, THE SUTURE REPEATEDLY DETACHED FROM THE NEEDLE DURING USE, INVOLVING FOUR SUTURES. DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301699 ↗MalfunctionMay 27, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE, THE SUTURE REPEATEDLY DETACHED FROM THE NEEDLE DURING USE, INVOLVING FOUR SUTURES. DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301302 ↗MalfunctionMay 27, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE, THE SUTURE REPEATEDLY DETACHED FROM THE NEEDLE DURING USE, INVOLVING FOUR SUTURES. DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301294 ↗MalfunctionMay 27, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE, THE SUTURE REPEATEDLY DETACHED FROM THE NEEDLE DURING USE, INVOLVING FOUR SUTURES. DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301291 ↗MalfunctionMay 22, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE, THE SUTURE REPEATEDLY DETACHED FROM THE NEEDLE DURING USE, INVOLVING FOUR SUTURES. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25256356 ↗
Other Johnson & Johnson International Inc. products
All Johnson & Johnson International Inc. devices →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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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