Coated VICRYL VCP753DRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10705031055339), received between Apr 29, 2019 and Apr 23, 2024 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Material Separation” (18 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.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE IN HALF. THE EVENT OCCURRED WHEN GOING THROUGH VERY SOFT TISSUE. THEY WERE ABLE TO RETRIEVE ALL PARTS OF THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164682 ↗
• MalfunctionApr 3, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL PLASTY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP THAT THE NEEDLE BROKE IN HALF DURING A VAGINAL PLASTY PROCEDURE. THEY WERE ABLE TO GET ANOTHER DEVICE TO COMPLETE THE CASE WITHOUT PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19034017 ↗
• MalfunctionFeb 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THE NEEDLES WERE POPPING OF ABNORMALLY AND WAY TO EASY WHERE THEY CAN'T PULL THE SUTURE THROUGH.THEY WERE ABLE TO COMPLETE THE TOTAL KNEE REPLACEMENT WITH A DIFFERENT LOT NUMBER. LOT THMCUA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18772591 ↗
• MalfunctionFeb 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THE NEEDLES WERE POPPING OF ABNORMALLY AND WAY TO EASY WHERE THEY CAN'T PULL THE SUTURE THROUGH. THEY WERE ABLE TO COMPLETE THE TOTAL KNEE REPLACEMENT WITH A DIFFERENT LOT NUMBER. LOT THMCUA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18772580 ↗
• MalfunctionFeb 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THE NEEDLES WERE POPPING OF ABNORMALLY AND WAY TO EASY WHERE THEY CAN'T PULL THE SUTURE THROUGH.THEY WERE ABLE TO COMPLETE THE TOTAL KNEE REPLACEMENT WITH A DIFFERENT LOT NUMBER. LOT THMCUA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18772572 ↗
• MalfunctionFeb 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THE NEEDLES WERE POPPING OF ABNORMALLY AND WAY TO EASY WHERE THEY CAN'T PULL THE SUTURE THROUGH.THEY WERE ABLE TO COMPLETE THE TOTAL KNEE REPLACEMENT WITH A DIFFERENT LOT NUMBER. LOT THMCUA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18772568 ↗
• MalfunctionFeb 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THE NEEDLES WERE POPPING OF ABNORMALLY AND WAY TO EASY WHERE THEY CAN'T PULL THE SUTURE THROUGH.THEY WERE ABLE TO COMPLETE THE TOTAL KNEE REPLACEMENT WITH A DIFFERENT LOT NUMBER. LOT THMCUA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18772561 ↗
• MalfunctionFeb 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THE NEEDLES WERE POPPING OF ABNORMALLY AND WAY TO EASY WHERE THEY CAN'T PULL THE SUTURE THROUGH.THEY WERE ABLE TO COMPLETE THE TOTAL KNEE REPLACEMENT WITH A DIFFERENT LOT NUMBER. LOT THMCUA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18772558 ↗
• MalfunctionFeb 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THE NEEDLES WERE POPPING OF ABNORMALLY AND WAY TO EASY WHERE THEY CAN'T PULL THE SUTURE THROUGH. THEY WERE ABLE TO COMPLETE THE TOTAL KNEE REPLACEMENT WITH A DIFFERENT LOT NUMBER. LOT THMCUA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18772556 ↗
• MalfunctionFeb 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THE NEEDLES WERE POPPING OF ABNORMALLY AND WAY TO EASY WHERE THEY CAN'T PULL THE SUTURE THROUGH.THEY WERE ABLE TO COMPLETE THE TOTAL KNEE REPLACEMENT WITH A DIFFERENT LOT NUMBER. LOT THMCUA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18772549 ↗
• MalfunctionFeb 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THE NEEDLES WERE POPPING OF ABNORMALLY AND WAY TO EASY WHERE THEY CAN'T PULL THE SUTURE THROUGH.THEY WERE ABLE TO COMPLETE THE TOTAL KNEE REPLACEMENT WITH A DIFFERENT LOT NUMBER. LOT THMCUA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18772546 ↗
• MalfunctionFeb 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THE NEEDLES WERE POPPING OF ABNORMALLY AND WAY TO EASY WHERE THEY CAN'T PULL THE SUTURE THROUGH.THEY WERE ABLE TO COMPLETE THE TOTAL KNEE REPLACEMENT WITH A DIFFERENT LOT NUMBER. LOT THMCUA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18772504 ↗
• MalfunctionAug 31, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE THE DEEP PART OF WOUND WAS CLOSING WITH INTERRUPTED SUTURING, THE SUTURE BROKE CONTINUOUSLY. IT WAS UNKNOWN HOW MANY SUTURES WERE BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15325960 ↗
• MalfunctionAug 31, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE THE DEEP PART OF WOUND WAS CLOSING WITH INTERRUPTED SUTURING, THE SUTURE BROKE CONTINUOUSLY. IT WAS UNKNOWN HOW MANY SUTURES WERE BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15325958 ↗
• MalfunctionJan 13, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13253219 ↗
• MalfunctionNov 30, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN PULLING THE SUTURE AFTER APPLYING A STITCH, THE SUTURE BROKE. THIS OCCURRED WITH 2 SUTURES IN THE SAME PACKAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12894228 ↗
• MalfunctionNov 30, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN PULLING THE SUTURE AFTER APPLYING A STITCH, THE SUTURE BROKE. THIS OCCURRED WITH 2 SUTURES IN THE SAME PACKAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12894072 ↗
• MalfunctionJun 7, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE WHEN PASSING THE NEEDLE THROUGH BOTH SIDES OF THE FASCIA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11945926 ↗
• MalfunctionMay 11, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE WHEN PASSING THROUGH THE FASCIA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809003 ↗
• MalfunctionMay 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL AORTIC ANEURYSM SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE UNINTENDEDLY WHILE CLOSING THE SURGICAL WOUND BY INTERRUPTED SUTURING ON THE MUSCLE LAYER. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10088032 ↗
• MalfunctionMay 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL AORTIC ANEURYSM SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE UNINTENDEDLY WHILE CLOSING THE SURGICAL WOUND BY INTERRUPTED SUTURING ON THE MUSCLE LAYER. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10088031 ↗
• MalfunctionMay 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL AORTIC ANEURYSM SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE UNINTENDEDLY WHILE CLOSING THE SURGICAL WOUND BY INTERRUPTED SUTURING ON THE MUSCLE LAYER. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10088018 ↗
• MalfunctionJul 31, 2019Material Separation; Material Separation

  THIS REPORT SUMMARIZES <NOE> 22 </NOE> MALFUNCTION EVENTS, INCLUDING 0 INITIAL EVENTS. IT SUMMARIZES 22 FOLLOW UP MALFUNCTION EVENTS, INCLUDING 5 SUTURE BREAKAGE, 10 NEEDLE BREAKAGE AND 7 NEEDLE PULL-OFF THAT OCCURRED INTRAOPERATIVELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8847618 ↗
• MalfunctionApr 29, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE WHEN PASSING THE NEEDLE THROUGH THE TISSUE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8561971 ↗

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, Classified
  VICRYL 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 · Terminated
  Coated VICRYL Plus Antibacterial (polyglactin 910) Suture; Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and