VICRYL V448GRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031051256), received between Jan 30, 2019 and Feb 3, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 reports).

11 other recalls cover devices cleared under the same FDA submission (K022269, K946173); 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING SURGERY THE SUTURE KEEPS BREAKING. NO OTHER INFORMATION GIVEN. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246566 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING SURGERY THE SUTURE KEEPS BREAKING. NO OTHER INFORMATION GIVEN. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246565 ↗
• MalfunctionDec 9, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WOULD POP OFF THE SUTURE, AND THE DOCTOR NEEDS TO MAKE MORE PASSES WITH THE NEEDLE BUT IS UNABLE TO DO SO. IT IS STATED THIS HAS HAPPENED AT LEAST THREE OTHER TIMES. SEVERAL SUTURES WERE USED TO COMPLETE THE PROCEDURE. IT IS STATED THAT THIS DOES PROLONG THE TIME OF THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949334 ↗
• MalfunctionDec 8, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WOULD POP OFF THE SUTURE, AND THE DOCTOR NEEDS TO MAKE MORE PASSES WITH THE NEEDLE BUT IS UNABLE TO. STATED THIS HAS HAPPENED AT LEAST THREE OTHER TIMES. SEVERAL SUTURES WERE USED TO COMPLETE THE PROCEDURE. STATED THAT THIS DOES PROLONG THE TIME OF THE PROCEDURE.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15940625 ↗
• MalfunctionDec 8, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WOULD POP OFF THE SUTURE, AND THE DOCTOR NEEDS TO MAKE MORE PASSES WITH THE NEEDLE BUT IS UNABLE TO. STATED THIS HAS HAPPENED AT LEAST THREE OTHER TIMES. SEVERAL SUTURES WERE USED TO COMPLETE THE PROCEDURE. STATED THAT THIS DOES PROLONG THE TIME OF THE PROCEDURE.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15940604 ↗
• MalfunctionDec 8, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WOULD POP OFF THE SUTURE, AND THE DOCTOR NEEDS TO MAKE MORE PASSES WITH THE NEEDLE BUT IS UNABLE TO. STATED THIS HAS HAPPENED AT LEAST THREE OTHER TIMES. SEVERAL SUTURES WERE USED TO COMPLETE THE PROCEDURE. STATED THAT THIS DOES PROLONG THE TIME OF THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15940587 ↗
• MalfunctionJan 30, 2019Break; Break

  THIS REPORT SUMMARIZES <NOE> 458 </NOE> INITIAL MALFUNCTION EVENTS, INCLUDING 188 SUTURE BREAKAGE, 81 NEEDLE BREAKAGE AND 189 NEEDLE PULL-OFF THAT OCCURRED INTRAOPERATIVELY. IT ALSO SUMMARIZES 45 FOLLOW UP MALFUNCTION EVENTS, INCLUDING 34 SUTURE BREAKAGE, 8 NEEDLE BREAKAGE AND 3 NEEDLE PULL-OFF THAT OCCURRED INTRAOPERATIVELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8289417 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269, K946173. One submission often covers many models, so check the product and lot details in each record.

• Z-1516-2025 · Mar 7, 2025 · Open, Classified
  ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
• Z-1097-2025 · Dec 20, 2024 · Open, Classified
  PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovas
• 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-2486-2020 · Jun 10, 2020 · Open, Classified
  PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870
• 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-1841-2019 · Apr 19, 2019 · Terminated
  ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue app
• Z-1842-2019 · Apr 19, 2019 · Terminated
  ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue appr
• Z-0747-2019 · Dec 18, 2018 · Terminated
  PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approxima
• Z-1839-2015 · May 8, 2015 · Terminated
  Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast ab
• Z-0492-2015 · Oct 17, 2014 · Terminated
  Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
• 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