Coated VICRYL VCP433HRecalls & reported problems
Ethicon, LLC · Antibacterial Undyed Braided (Polyglactin 910), Synthetic Absorbable Suture · Class 2 · Implant
All models of Coated VICRYL (350)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon Coated VICRYL is an absorbable surgical stitch. Most of its 1,104 reports describe the suture material separating or breaking, and the reports include 1 death and 15 injuries. Reports fell to 116 in the last 12 months from 493 in the previous 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,093
- Deaths reported
- 1
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,093 adverse event reports that list this exact device (DI 10705031053199), received between Oct 3, 2018 and Sep 25, 2026 — classified as 1 death, 15 injuries, 1,077 malfunctions.
The most frequently reported specific device problem is “Material Separation” (681 reports).
2 other recalls cover devices cleared under the same FDA submission (K032420, K132580, K181652); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation681
- Break403
- Adverse Event Without Identified Device or Use Problem12
- Material Frayed4
- Defective Component3
- Difficult to Open or Remove Packaging Material3
- Material Integrity Problem3
- Component Misassembled2
Patient problems
- No Clinical Signs, Symptoms or Conditions1,025
- No Consequences Or Impact To Patient42
- Swelling/ Edema7
- Impaired Healing6
- Pain6
- Hemorrhage/Blood Loss/Bleeding5
- Insufficient Information5
- Wound Dehiscence5
Recent adverse event reports
The 25 most recent of 1,093 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902717 ↗MalfunctionSep 24, 2026Break
It was reported that a patient underwent an Unknown procedure on (b)(6) 2026, and suture was used. It was reported that the suture was broken when the surgeon attempted to sew the tissue. Changed another one to complete the surgery. There is no report on patient's injury. No additional information could be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882810 ↗MalfunctionSep 24, 2026Material Separation
It was reported that a patient underwent an Unknown procedure on (b)(6) 2026, and suture was used. At 15:00, the patient came to the hospital for surgical treatment due to black papules on the right thigh that had been present for more than 10 years. At 3:50 pm, the doctor used suture, and at 3:50 pm, the problem of pulling off suture needle happened. At 3:52 pm, the doctor replaced the suture and continued to suture to complete the surgical operation. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882721 ↗MalfunctionSep 23, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872627 ↗MalfunctionSep 18, 2026Material Separation
It was reported that a patient underwent a Debridement and removal of necrotic tissue procedure under brachial plexus anesthesia on (b)(6)2026 and suture was used. Suture was required during the surgery, and during the suturing process, there was a detachment of the suture and needle connection, resulting in the problem of pulling off suture needle. This phenomenon occurred multiple times on site. No adverse patient consequences were reported. Additional information was requested
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818994 ↗MalfunctionSep 18, 2026Material Separation
It was reported that a patient underwent a Debridement and removal of necrotic tissue procedure under brachial plexus anesthesia on (b)(6) 2026 and suture was used. Suture was required during the surgery, and during the suturing process, there was a detachment of the suture and needle connection, resulting in the problem of pulling off suture needle. This phenomenon occurred multiple times on site. No adverse patient consequences were reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818854 ↗MalfunctionSep 4, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50611333 ↗MalfunctionAug 26, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50452078 ↗MalfunctionAug 26, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50452077 ↗MalfunctionAug 26, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50452076 ↗MalfunctionAug 26, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50452073 ↗MalfunctionAug 20, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50348774 ↗MalfunctionAug 20, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50348675 ↗MalfunctionAug 19, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50326276 ↗MalfunctionAug 19, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50326267 ↗MalfunctionJul 2, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A FALLOPIAN TUBE RECANALIZATION SURGERY PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED. AT 10:42, DURING FALLOPIAN TUBE RECANALIZATION, THE NEEDLE TIP AND SUTURE BROKE. THE DOCTOR IMMEDIATELY STOPPED SUTURING AND CHECKED IF THE SUTURE WAS COMPLETE. THE DOCTOR IMMEDIATELY REPLACED THE SUTURE WITH A NEW ONE TO CONTINUE SUTURING. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25690829 ↗MalfunctionMay 29, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. THE PATIENT CAME TO THE HOSPITAL FOR TREATMENT OF RIGHT INGUINAL HERNIA. AT 9:45 AM, THE PATIENT UNDERWENT SURGERY ACCORDING TO THE DOCTOR'S ADVICE. AT 10:00 AM, THE DOCTOR FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND THE MEDICAL STAFF GAVE TREATMENT SUCH AS REPLACING THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25329977 ↗MalfunctionMay 28, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A LIPOSUCTION+ABDOMINAL WALL PLASTIC SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. ON THE MORNING, THE PATIENT UNDERWENT SURGERY. WHEN THE DOCTOR USED SUTURE TO SUTURE THE PATIENT, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, CAUSING UNNECESSARY PAIN DURING SUTURING. THE DOCTOR IMMEDIATELY REPLACED THE SUTURE WITH A NEW ONE FOR THE PATIENT TO SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Pain
MAUDE report 25322409 ↗MalfunctionMay 15, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE USING ON THE OPERATING TABLE, THE DOCTOR OPENED THE SUTURE AND FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED . CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25185629 ↗MalfunctionMay 12, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN PIGMENT REMOVAL SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. VISUAL INSPECTION REVEALED THAT ONE WINDING FORMER WITH A NEEDLE AND SUTURE OUTSIDE THE FOIL PACKET. PRODUCT CODE VCP433H. DURING EXAMINATION, A SHORT INSERTION LENGTH WAS OBSERVED AT THE SUTURE END, AND NO REMNANT WAS FOUND WITHIN THE NEEDLE BARREL HOLE. UPON VISUAL INSPECTION OF THE RETURNED SAMPLE, IT WAS DETERMINED THAT THE NEEDLE AND SUTURE WERE DETACHED DUE TO THE SUTURE INSERTION DID NOT MEET THE SPECIFIED ACCEPTANCE CRITERIA. NO ADDITIONAL INFORMATION COULD BE PROVIDED. .NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25153468 ↗MalfunctionMay 12, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. THE DOCTOR REMOVED THE PRODUCT AND CONFIRMED ITS COMPLETENESS BY COMPARING IT WITH THE PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150019 ↗MalfunctionMay 4, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL RETURN 15 REPRESENTATIVE SAMPLES FOR ANALYSIS. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE NEEDLE DID NOT FELL INTO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25072979 ↗MalfunctionMay 4, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN CLOSURE PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25068143 ↗MalfunctionApr 30, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SURGEON USE VCP433H, IT'S BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25044679 ↗MalfunctionApr 23, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN PIGMENT REMOVAL SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24969033 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K032420, K132580, K181652. One submission often covers many models, so check the product and lot details in each record.
- Z-2145-2024 · May 10, 2024 · Open, ClassifiedVICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological
- Z-1310-2009 · Feb 2, 2009 · TerminatedCoated VICRYL Plus Antibacterial (polyglactin 910) Suture; Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and
Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices
- Polysorb CL-915Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID503 reports
- Coated VICRYL VCP493HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID435 reports
- V-Loc 180 VLOCL0316Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall376 reports
- Coated VICRYL VCP345HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death405 reports
- V-Loc 180 VLOCL0604Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall328 reports
- V-Loc 180 VLOCA008LCovidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall294 reports
- V-Loc 180 VLOCL0326Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID330 reports
- Polysorb CL-923Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID321 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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