Coated VICRYL J207GRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10705031038158), received between Apr 5, 2019 and Jun 4, 2024 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Component Incompatible” (11 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED TO TIE OFF A BLOOD VESSEL. THE SUTURE MATERIAL BROKE UNDER NORMAL TENSION WHEN TYING. THE SURGEON OPINED THAT THIS STRAND WAS WEAK AND BROKE EASILY DURING WHEN TYING. VASCULAR CONTROL WAS REGAINED BY GRABBING THE VESSEL. NO PATIENT HARM OR CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463465 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024AND SUTURE WAS USED TO TIE OFF A BLOOD VESSEL. THE SUTURE MATERIAL BROKE UNDER NORMAL TENSION WHEN TYING. THE SURGEON OPINED THAT THIS STRAND WAS WEAK AND BROKE EASILY DURING WHEN TYING. VASCULAR CONTROL WAS REGAINED BY GRABBING THE VESSEL. NO PATIENT HARM OR CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463464 ↗
• MalfunctionNov 28, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT SUTURE MAY HAVE BROKEN DOWN VERY QUICKLY CAUSING FURTHER COMPLICATIONS WITH THE DOG AFTER A CANINE CASTRATION. IT IS UNKNOWN IF 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 15875358 ↗
• MalfunctionJun 22, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE PACKAGE SAID A SIZE FOR THE REEL AND THE SUTURE APPEARED TO BE THAT SIZE. THE REEL DOTS AND HOLES INDICATED A DIFFERENT SIZE SUTURE. UPON EVALUATION OF THE RETURNED DEVICE, A MISMATCH AT THE SPOOL WAS FOUND. THERE WERE NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046908 ↗
• MalfunctionJun 22, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE PACKAGE SAID A SIZE FOR THE REEL AND THE SUTURE APPEARED TO BE THAT SIZE. THE REEL DOTS AND HOLES INDICATED A DIFFERENT SIZE SUTURE. UPON EVALUATION OF THE RETURNED DEVICE, A MISMATCH AT THE SPOOL WAS FOUND. THERE WERE NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046907 ↗
• MalfunctionJun 22, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE PACKAGE SAID A SIZE FOR THE REEL AND THE SUTURE APPEARED TO BE THAT SIZE. THE REEL DOTS AND HOLES INDICATED A DIFFERENT SIZE SUTURE. UPON EVALUATION OF THE RETURNED DEVICE, A MISMATCH AT THE SPOOL WAS FOUND. THERE WERE NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046906 ↗
• MalfunctionJun 22, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE PACKAGE SAID A SIZE FOR THE REEL AND THE SUTURE APPEARED TO BE THAT SIZE. THE REEL DOTS AND HOLES INDICATED A DIFFERENT SIZE SUTURE. UPON EVALUATION OF THE RETURNED DEVICE, A MISMATCH AT THE SPOOL WAS FOUND. THERE WERE NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046905 ↗
• MalfunctionJun 22, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE PACKAGE SAID A SIZE FOR THE REEL AND THE SUTURE APPEARED TO BE THAT SIZE. THE REEL DOTS AND HOLES INDICATED A DIFFERENT SIZE SUTURE. UPON EVALUATION OF THE RETURNED DEVICE, A MISMATCH AT THE SPOOL WAS FOUND. THERE WERE NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046904 ↗
• MalfunctionNov 16, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. BEFORE THE PROCEDURE, IT WAS FOUND THAT THE PACKAGE INDICATED A DIFFERENT SUTURE SIZE THAN ON THE REEL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10847413 ↗
• MalfunctionJul 31, 2019Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NURSE OPENED THE SUTURE AND REALIZED IT WAS THE RIGHT SUTURE BUT WRONG PLASTIC COVER PUT ON IT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8846371 ↗
• MalfunctionJul 18, 2019Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT A 2-0 REEL WAS IN 0 PACKAGING. TWO CIRCLE CUTOUT ON REEL INDICATING IT'S A 2-0. THE REPORTER WAS UNSURE THE ACTUAL SUTURE PRESENT ON THE REEL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8803281 ↗
• MalfunctionJul 18, 2019Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT A 2-0 REEL WAS IN 0 PACKAGING. TWO CIRCLE CUTOUT ON REEL INDICATING IT'S A 2-0. THE REPORTER WAS UNSURE THE ACTUAL SUTURE PRESENT ON THE REEL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8803272 ↗
• MalfunctionJul 18, 2019Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019, AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT A 2-0 REEL WAS IN 0 PACKAGING. TWO CIRCLE CUTOUT ON REEL INDICATING IT'S A 2-0. THE REPORTER WAS UNSURE THE ACTUAL SUTURE PRESENT ON THE REEL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8803266 ↗
• MalfunctionJun 25, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS A DIFFERENT SIZE THAN WHAT WAS ON THE PACKAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8731152 ↗
• MalfunctionJun 13, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DEVICE APPEARS TO BE "0" VICRYL TIES BUT PLACED ONTO THE "2/0" REEL. PACKAGED IN "0 VICRYL" PACKAGING. THIS HAS BEEN NOTICED FREQUENTLY RECENTLY. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8698490 ↗
• MalfunctionJun 13, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DEVICE APPEARS TO BE "0" VICRYL TIES BUT PLACED ONTO THE "2/0" REEL. PACKAGED IN "0 VICRYL" PACKAGING. THIS HAS BEEN NOTICED FREQUENTLY RECENTLY. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8698481 ↗
• MalfunctionMay 28, 2019Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT A 2-0 REEL WAS IN 0 PACKAGING. TWO CIRCLE CUTOUT ON REEL INDICATING IT'S A 2-0. THE REPORTER WAS UNSURE THE ACTUAL SUTURE PRESENT ON THE REEL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8648340 ↗
• MalfunctionMay 22, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NURSE OPENED THE TIE REEL AND REALIZED THE REEL STATED THIS WAS A 2-0 REEL OF TIES (TWO DOTS) AND NOT A 0 AS THE PRODUCT CODE AND BOX INDICATES. NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8631893 ↗
• MalfunctionMay 8, 2019Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE USED. THE ACCOUNT REPORTED NOTICING THE DISPENSING REEL HAVING 2 DOTS INDICATING REEL SHOULD BE A 2-0 SIZE THREAD. IT WAS NOT REPORTED THAT THE SUTURE WAS USED ON THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8592792 ↗
• MalfunctionMay 8, 2019Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT THE INTERNAL PACKAGING OF SUTURE DOES NOT MATCH THE BOX PACKAGING OR PACKAGING OF SUTURE. THERE IS SIZE 0 ON THE BOX, SIZE 0 ON THE SUTURE PACKAGING, BUT SUTURE IS 2-0. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8592315 ↗
• MalfunctionMay 8, 2019Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT THE INTERNAL PACKAGING OF SUTURE DOES NOT MATCH THE BOX PACKAGING OR PACKAGING OF SUTURE. THERE IS SIZE 0 ON THE BOX, SIZE 0 ON THE SUTURE PACKAGING, BUT SUTURE IS 2-0. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8592299 ↗
• MalfunctionMay 8, 2019Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT THE INTERNAL PACKAGING OF SUTURE DOES NOT MATCH THE BOX PACKAGING OR PACKAGING OF SUTURE. THERE IS SIZE 0 ON THE BOX, SIZE 0 ON THE SUTURE PACKAGING, BUT SUTURE IS 2-0. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8592121 ↗
• MalfunctionMay 8, 2019Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT THE INTERNAL PACKAGING OF SUTURE DOES NOT MATCH THE BOX PACKAGING OR PACKAGING OF SUTURE. THERE IS SIZE 0 ON THE BOX, SIZE 0 ON THE SUTURE PACKAGING, BUT SUTURE IS 2-0. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8592084 ↗
• MalfunctionApr 17, 2019Component Incompatible; Inadequacy of Device Shape and/or Size; Component Incompatible; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE INTERNAL PACKAGING OF SUTURE DOES NOT MATCH THE BOX PACKAGING OR PACKAGING OF SUTURE. THERE IS SIZE 0 ON THE BOX, SIZE 0 ON THE SUTURE PACKAGING, BUT SUTURE IS 2-0. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8524482 ↗
• MalfunctionApr 17, 2019Component Incompatible; Inadequacy of Device Shape and/or Size; Component Incompatible; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE INTERNAL PACKAGING OF SUTURE DOES NOT MATCH THE BOX PACKAGING OR PACKAGING OF SUTURE. THERE IS SIZE 0 ON THE BOX, SIZE 0 ON THE SUTURE PACKAGING, BUT SUTURE IS 2-0. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8524310 ↗

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