Coated VICRYL J433HRecalls & reported problems

Summary

The FDA's MAUDE database contains 255 adverse event reports that list this exact device (DI 10705031039827), received between Sep 28, 2018 and Aug 25, 2026 — classified as 2 injuries, 253 malfunctions.

The most frequently reported specific device problem is “Material Separation” (200 reports).

3 other recalls cover devices cleared under the same FDA submission (K022269); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 255 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50441007 ↗
• MalfunctionJun 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A APPENDECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THIS CASE IS FROM HEALTH AUTHORITY. AT 15:15, DURING THE SURGICAL SUTURE PROCESS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND THE DOCTOR IMMEDIATELY REPLACED THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25596588 ↗
• MalfunctionJun 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SURGERY, THE SURGEON FREQUENTLY EXPERIENCED NEEDLE PULL OFF ISSUE, SUTURE BREAKAGE WHILE USING. FIVE PRODUCTS HAVE SAME NEEDLE PULL OFF ISSUE. THE SURGERY WAS COMPLETED BY CHANGING THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25540413 ↗
• MalfunctionJun 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SURGERY, THE SURGEON FREQUENTLY EXPERIENCED NEEDLE PULL OFF ISSUE, SUTURE BREAKAGE WHILE USING. FIVE PRODUCTS HAVE SAME NEEDLE PULL OFF ISSUE. THE SURGERY WAS COMPLETED BY CHANGING THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25540234 ↗
• MalfunctionJun 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SURGERY, THE SURGEON FREQUENTLY EXPERIENCED NEEDLE PULL OFF ISSUE, SUTURE BREAKAGE WHILE USING. FIVE PRODUCTS HAVE SAME NEEDLE PULL OFF ISSUE. THE SURGERY WAS COMPLETED BY CHANGING THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25539523 ↗
• MalfunctionJun 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SURGERY, THE SURGEON FREQUENTLY EXPERIENCED NEEDLE PULL OFF ISSUE, SUTURE BREAKAGE WHILE USING. FIVE PRODUCTS HAVE SAME NEEDLE PULL OFF ISSUE. THE SURGERY WAS COMPLETED BY CHANGING THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25539215 ↗
• MalfunctionJun 17, 2026Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SURGERY, THE SURGEON FREQUENTLY EXPERIENCED NEEDLE PULL OFF ISSUE, SUTURE BREAKAGE WHILE USING. FIVE PRODUCTS HAVE SAME NEEDLE PULL OFF ISSUE. THE SURGERY WAS COMPLETED BY CHANGING THE SUTURE NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25538918 ↗
• MalfunctionJun 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT TOTAL 7 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE DURING THE SURGERY. THE SUTURE BROKE WITH A GENTLE PULL. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WILL RETURN 7 ACTUAL PRODUCTS AND 49 REPRESENTATIVE SAMPLES FOR ANALYSIS. AMONG THEM, THERE ARE 3 ACTUAL PRODUCTS AND 3 REPRESENTATIVE SAMPLES WITH LOT NUMBER 104P3U; THERE ARE 4 ACTUAL PRODUCTS AND 39 REPRESENTATIVE SAMPLES WITH LOT NUMBER 108481. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25501697 ↗
• MalfunctionJun 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT TOTAL 7 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE DURING THE SURGERY. THE SUTURE BROKE WITH A GENTLE PULL. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WILL RETURN 7 ACTUAL PRODUCTS AND 49 REPRESENTATIVE SAMPLES FOR ANALYSIS. AMONG THEM, THERE ARE 3 ACTUAL PRODUCTS AND 3 REPRESENTATIVE SAMPLES WITH LOT NUMBER 104P3U ; THERE ARE 4 ACTUAL PRODUCTS AND 39 REPRESENTATIVE SAMPLES WITH LOT NUMBER 108481. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25501696 ↗
• MalfunctionJun 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT TOTAL 7 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE DURING THE SURGERY. THE SUTURE BROKE WITH A GENTLE PULL. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WILL RETURN 7 ACTUAL PRODUCTS AND 49 REPRESENTATIVE SAMPLES FOR ANALYSIS. AMONG THEM, THERE ARE 3 ACTUAL PRODUCTS AND 3 REPRESENTATIVE SAMPLES WITH LOT NUMBER 104P3U ; THERE ARE 4 ACTUAL PRODUCTS AND 39 REPRESENTATIVE SAMPLES WITH LOT NUMBER 108481. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25501624 ↗
• MalfunctionJun 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT TOTAL 7 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE DURING THE SURGERY. THE SUTURE BROKE WITH A GENTLE PULL. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WILL RETURN 7 ACTUAL PRODUCTS AND 49 REPRESENTATIVE SAMPLES FOR ANALYSIS. AMONG THEM, THERE ARE 3 ACTUAL PRODUCTS AND 3 REPRESENTATIVE SAMPLES WITH LOT NUMBER 104P3U ; THERE ARE 4 ACTUAL PRODUCTS AND 39 REPRESENTATIVE SAMPLES WITH LOT NUMBER 108481. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25501618 ↗
• MalfunctionJun 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT TOTAL 7 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE DURING THE SURGERY. THE SUTURE BROKE WITH A GENTLE PULL. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WILL RETURN 7 ACTUAL PRODUCTS AND 49 REPRESENTATIVE SAMPLES FOR ANALYSIS. AMONG THEM, THERE ARE 3 ACTUAL PRODUCTS AND 3 REPRESENTATIVE SAMPLES WITH LOT NUMBER 104P3U ; THERE ARE 4 ACTUAL PRODUCTS AND 39 REPRESENTATIVE SAMPLES WITH LOT NUMBER 108481. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25501613 ↗
• MalfunctionApr 21, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, AROUND 12:20, WHEN THE SURGICAL INCISION WAS CLOSED, 2-3 STITCHES WERE JUST STARTED TO BE SUTURED. HOWEVER, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND COULD NOT CONTINUE SUTURING. THE NEEDLE WAS INTACT, AND THE DOCTOR REPLACED IT WITH A NEW SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941678 ↗
• MalfunctionApr 1, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TUMOR RESECTION 0N (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE BEFORE USING ON PATIENT DURING SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755743 ↗
• MalfunctionMar 31, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TUMOR RESECTION ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT TOTAL 2 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE IN THE NEWLY DISPENSED SUTURE BEFORE USING ON PATIENT DURING SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WILL RETURN 16 REPRESENTATIVE SAMPLES FOR ANALYSIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746329 ↗
• MalfunctionMar 31, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TUMOR RESECTION ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT TOTAL 2 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE IN THE NEWLY DISPENSED SUTURE BEFORE USING ON PATIENT DURING SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WILL RETURN 16 REPRESENTATIVE SAMPLES FOR ANALYSIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746326 ↗
• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. AT 11:37, DURING THE DEBRIDEMENT AND SUTURING OF THE PATIENT'S EXTERNAL INJURY, THE SUTURE BROKE WHEN IT WAS ABOUT TO KNOT. A NEW SUTURE WAS IMMEDIATELY REPLACED AND SUTURED NORMALLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662647 ↗
• MalfunctionMar 17, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE HAD FRAYED AND UNRAVEL OR COME A PART IN THE PHOTOS I WAS SHOWN. THE REP WAS NOT THERE AND THIS HAPPENED LAST WEEK. NO ADVERSE IMPACT TO THE PATIENT/USER. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617654 ↗
• MalfunctionMar 17, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE HAD FRAYED AND UNRAVEL OR COME APART IN THE PHOTOS I WAS SHOWN. THE REP WAS NOT THERE AND THIS HAPPENED LAST WEEK. NO ADVERSE IMPACT TO THE PATIENT/USER. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617633 ↗
• MalfunctionMar 17, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE HAD FRAYED AND UNRAVEL OR COME A PART IN THE PHOTOS I WAS SHOWN. THE REP WAS NOT THERE AND THIS HAPPENED LAST WEEK. NO ADVERSE IMPACT TO THE PATIENT/USER. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617611 ↗
• MalfunctionMar 17, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE HAD FRAYED AND UNRAVEL OR COME A PART IN THE PHOTOS I WAS SHOWN. THE REP WAS NOT THERE AND THIS HAPPENED LAST WEEK. NO ADVERSE IMPACT TO THE PATIENT/USER. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617436 ↗
• MalfunctionMar 17, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE HAD FRAYED AND UNRAVEL OR COME A PART IN THE PHOTOS I WAS SHOWN. THE REP WAS NOT THERE AND THIS HAPPENED LAST WEEK. NO ADVERSE IMPACT TO THE PATIENT/USER. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617407 ↗
• MalfunctionMar 17, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE HAD FRAYED AND UNRAVEL OR COME A PART IN THE PHOTOS I WAS SHOWN. THE REP WAS NOT THERE AND THIS HAPPENED LAST WEEK. NO ADVERSE IMPACT TO THE PATIENT/USER. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617400 ↗
• MalfunctionMar 17, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE HAD FRAYED AND UNRAVEL OR COME A PART IN THE PHOTOS I WAS SHOWN. THE REP WAS NOT THERE AND THIS HAPPENED LAST WEEK. NO ADVERSE IMPACT TO THE PATIENT/USER. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617398 ↗
• MalfunctionMar 17, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE HAD FRAYED AND UNRAVEL OR COME A PART IN THE PHOTOS I WAS SHOWN. THE REP WAS NOT THERE AND THIS HAPPENED LAST WEEK. NO ADVERSE IMPACT TO THE PATIENT/USER. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617346 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269. One submission often covers many models, so check the product and lot details in each record.

• Z-2144-2024 · May 10, 2024 · Open, Classified
  VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and
• Z-0989-2020 · Jan 3, 2020 · Terminated
  Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
• Z-1087-06 · May 4, 2006 · Terminated
  Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gyc