Coated VICRYLRecalls & reported problems across all models
Ethicon Inc. · 114 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,904
- Deaths reported
- 2
- Injuries reported
- 334
- Recalls
- 0
We found 114 models of Coated VICRYL by Ethicon Inc. in the FDA's device registry (GUDID). Together they are named in 2,904 adverse event reports in the FDA's MAUDE database, received between Feb 1, 2013 and Sep 30, 2026 — classified as 2 deaths, 334 injuries, 2,568 malfunctions.
The most frequently reported specific device problem is “Break” (1,279 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
- Break1,279
- Material Separation1,157
- Adverse Event Without Identified Device or Use Problem237
- Appropriate Device Problem Term/Code Not Available70
- Material Frayed58
- Material Integrity Problem58
- Defective Component41
- Component Misassembled32
Patient problems
- No Clinical Signs, Symptoms or Conditions2,030
- No Consequences Or Impact To Patient449
- Wound Dehiscence152
- Inflammation96
- Not Applicable85
- Impaired Healing75
- Unspecified Infection67
- Fluid Discharge65
Coated VICRYL models
114 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Coated VICRYL VCP359HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death315 reports
- Coated VICRYL VCP358HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID312 reports
- Coated VICRYL VCP422HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID176 reports
- Coated VICRYL VCP316HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID146 reports
- Coated VICRYL VCP397HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID130 reports
- Coated VICRYL VCPB841DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID124 reports
- Coated VICRYL VCP310HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID123 reports
- Coated VICRYL VCP317HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID90 reports
- Coated VICRYL VCP416HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID82 reports
- Coated VICRYL VCP442HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death82 reports
- Coated VICRYL J358HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID73 reports
- Coated VICRYL VCP353HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID69 reports
- Coated VICRYL VCP346HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID68 reports
- Coated VICRYL VCP426HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID68 reports
- Coated VICRYL VCP864DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID61 reports
- Coated VICRYL VCP452HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID59 reports
- Coated VICRYL VCP347HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID47 reports
- Coated VICRYL J423HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID36 reports
- Coated VICRYL VCP443HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID35 reports
- Coated VICRYL VCP357HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID33 reports
- Coated VICRYL VCP936HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID33 reports
- Coated VICRYL VCP496HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID32 reports
- Coated VICRYL VCP739DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID32 reports
- Coated VICRYL VCP840DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID32 reports
- Coated VICRYL VCP259HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID27 reports
- Coated VICRYL VCP345HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID23 reports
- Coated VICRYL VCP422HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID23 reports
- Coated VICRYL VCP427HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID22 reports
- Coated VICRYL VCP741DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID22 reports
- Coated VICRYL VCP316HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID22 reports
- Coated VICRYL VCP218HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID21 reports
- Coated VICRYL J841DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID19 reports
- Coated VICRYL VCP423HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID19 reports
- Coated VICRYL VCP323HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID18 reports
- Coated VICRYL VCP398HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID18 reports
- Coated VICRYL VCP774DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID18 reports
- Coated VICRYL J270HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID15 reports
- Coated VICRYL VCP839DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID15 reports
- Coated VICRYL VCP359HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID15 reports
- Coated VICRYL J765DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID14 reports
- Coated VICRYL VCP726DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID14 reports
- Coated VICRYL VCP452HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID14 reports
- Coated VICRYL VCP740DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID13 reports
- Coated VICRYL VCP416HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID13 reports
- Coated VICRYL VCP397HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID12 reports
- Coated VICRYL J397HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID11 reports
- Coated VICRYL J351HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID10 reports
- Coated VICRYL J516HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID10 reports
- Coated VICRYL VCP415HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID10 reports
- Coated VICRYL VCP332HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID9 reports
- Coated VICRYL VCP869HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID9 reports
- Coated VICRYL VCP334HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID8 reports
- Coated VICRYL VCP351HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID8 reports
- Coated VICRYL VCP310HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID8 reports
- Coated VICRYL VCP358HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID8 reports
- Coated VICRYL J452HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID7 reports
- Coated VICRYL VCP347HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID7 reports
- Coated VICRYL J398HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID6 reports
- Coated VICRYL J441HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID6 reports
- Coated VICRYL VCP393HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID6 reports
- Coated VICRYL VCP497GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID6 reports
- Coated VICRYL VCP727DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID6 reports
- Coated VICRYL VCP775DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID6 reports
- Coated VICRYL VCP346HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID6 reports
- Coated VICRYL J334HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID5 reports
- Coated VICRYL VCP441HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID5 reports
- Coated VICRYL VCP442HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID5 reports
- Coated VICRYL J356HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID4 reports
- Coated VICRYL J472HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID4 reports
- Coated VICRYL VCP270HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID4 reports
- Coated VICRYL VCP356HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID4 reports
- Coated VICRYL VCP841DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID4 reports
- Coated VICRYL VCP392ZHSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID4 reports
- Coated VICRYL VCP496ZHSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID4 reports
- Coated VICRYL VCP945HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID4 reports
- Coated VICRYL VCP946HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID4 reports
- Coated VICRYL VCP317HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID4 reports
- Coated VICRYL VCP351HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID4 reports
- Coated VICRYL J466HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Coated VICRYL J494HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Coated VICRYL J739DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Coated VICRYL J869HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Coated VICRYL VCP315HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Coated VICRYL VCP467HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Coated VICRYL VCP341HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Coated VICRYL VCP393HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Coated VICRYL VCP268HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Coated VICRYL VCP275HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Coated VICRYL VCP474HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Coated VICRYL VCP496GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Coated VICRYL VCP738DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Coated VICRYL VCP868HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Coated VICRYL VCP957HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Coated VICRYL VCP333HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Coated VICRYL VCP398HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Coated VICRYL VCP947HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Coated VICRYL VCP497HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Coated VICRYL J332HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Coated VICRYL J392HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Coated VICRYL J957HSUTURE, 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 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948759 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938892 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936875 ↗MalfunctionSep 29, 2026Delivered as Unsterile Product
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. An issue was identified where the needle protruded through the suture packaging and subsequently pierced the adjacent package, resulting in a hole in the neighboring package. No adverse patient consequences were reported. Additional information was requested
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936821 ↗MalfunctionSep 29, 2026Break
It was reported that a patient underwent a small bowel procedure on an unknown date and suture was used. During surgery, the tip of the needle driver was observed to be missing when the needle was returned. No adverse patient consequences were reported. Additional information was requested
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935564 ↗MalfunctionSep 29, 2026Break
It was reported that a patient underwent a small bowel procedure on an unknown date and suture was used. During surgery, the tip of the needle driver was observed to be missing when the needle was returned. No adverse patient consequences were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935473 ↗MalfunctionSep 28, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923061 ↗MalfunctionSep 28, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922454 ↗MalfunctionSep 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902777 ↗MalfunctionSep 25, 2026Break
It was reported that a patient underwent laparoscopic nephrectomy for renal lesions surgery on (b)(6)2026 and suture was used. When the surgeon performs tissue suturing, it is found that the suture used is significantly more brittle and prone to breakage. It breaks multiple times during normal knotting and pulling processes, seriously affecting the suturing efficiency and increasing surgical risks. The surgeon immediately stopped using the problematic suture and replaced it with another batch of suture of the same specification. After confirming that the suture's flexibility and strength were normal, the surgery continued. The patient's vital signs remained stable during the operation, and there were no postoperative bleeding or other complications due to suture issues. No further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902473 ↗MalfunctionSep 25, 2026Break
It was reported that a patient underwent laparoscopic nephrectomy for renal lesions surgery on (b)(6) 2026 and suture was used. When the surgeon performs tissue suturing, it is found that the suture used is significantly more brittle and prone to breakage. It breaks multiple times during normal knotting and pulling processes, seriously affecting the suturing efficiency and increasing surgical risks. The surgeon immediately stopped using the problematic suture and replaced it with another batch of suture of the same specification. After confirming that the suture's flexibility and strength were normal, the surgery continued. The patient's vital signs remained stable during the operation, and there were no postoperative bleeding or other complications due to suture issues. No further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902471 ↗MalfunctionSep 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902429 ↗MalfunctionSep 25, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50901208 ↗MalfunctionSep 25, 2026Material Separation
It was reported that a patient underwent a C-Section on (b)(6)2026 and suture was used. During the surgical process, when preparing to clamp and use the suture, it was found that the problem of pulling off suture needle happened. The use was immediately stopped and a new suture was replaced to continue suturing. There were no adverse patient consequences reported. No further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900704 ↗MalfunctionSep 25, 2026Break; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898691 ↗
Other Ethicon Inc. products
All Ethicon 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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