Coated VICRYL VCP762DRecalls & 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
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031055391), received between Jun 24, 2020 and Jul 3, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Device Markings/Labelling Problem2
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY ACCOUNT CONTACT THAT MULTIPLE SUTURES OF THE SAME LOT WITH ISSUES ON THE QR CODE. ½ HAVE BEEN ABLE TO SCAN AND ½ HAVE NOT BEEN ABLE TO DUE TO BLUR ON EDGES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. UNKNOWN IF THE DEVICE WAS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22396735 ↗MalfunctionJul 3, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY ACCOUNT CONTACT THAT MULTIPLE SUTURES OF THE SAME LOT WITH ISSUES ON THE QR CODE. ½ HAVE BEEN ABLE TO SCAN AND ½ HAVE NOT BEEN ABLE TO DUE TO BLUR ON EDGES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. UNKNOWN IF THE DEVICE WAS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22396734 ↗MalfunctionSep 13, 2023Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 2023 AND SUTURE CLIPS KIT WERE USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT THE CLIPS 'DO NOT WORK. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17741751 ↗MalfunctionJun 24, 2020Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING A SPIN "POCKET REVERSION" THE TIP OF THE NEEDLE BROKE OFF INSIDE THE PATIENT. THE TIP WAS FOUND AND REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE FROM A DIFFERENT LOT WITH NO PATIENT CONSEQUENCES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10188881 ↗MalfunctionJun 24, 2020Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING A SPIN "POCKET REVERSION" THE TIP OF THE NEEDLE BROKE OFF INSIDE THE PATIENT. THE TIP WAS FOUND AND REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE FROM A DIFFERENT LOT WITH NO PATIENT CONSEQUENCES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10188875 ↗
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
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- 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
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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