Coated VICRYL J416HRecalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10705031039667), received between May 15, 2018 and Apr 2, 2025 — classified as 11 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Break” (33 reports).

6 other recalls cover devices cleared under the same FDA submission (K022269, K183183); 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 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THAT POST-OP MULTIPLE ANIMAL PROCEDURES THAT THE SUTURE WOULD START TO DISSOLVE WITH IN DAYS CREATING WOUND DEHISCE. PATIENTS CURRENTLY DOING WELL.

  Patient problems: Wound Dehiscence

  MAUDE report 21754614 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, PROCEDURE THE SUTURE WOULD START TO DISSOLVE WITH IN DAYS CREATING WOUND DEHISCE. ANIMAL CURRENTLY DOING WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21753328 ↗
• InjuryJan 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DUAL CHAMBER PACEMAKER PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE END OF THE PROCEDURE, THE PHYSICIAN RECOGNIZED THAT THE SUTURE NEEDLE HAD BROKEN DURING THE PROCESS OF SUTURING THE PACEMAKER POCKET. A THOROUGH EXAMINATION WAS PERFORMED TO LOCATE THE BROKEN NEEDLE INCLUDING AN INTRA-OPERATIVE CHEST X-RAY. THE PHYSICIAN DETERMINED THAT THE X-RAY DID NOT REVEAL THAT THE BROKEN SUTURE WAS RETAINED IN THE BODY DESPITE NOT BEING ABLE TO LOCATE IT ON THE FIELD OR IN THE GENERAL SURGICAL AREA AND MADE A DECISION TO TRANSFER THE PATIENT TO THE CATH LAB HOLDING RECOVERY AREA WHERE A HIGHER RESOLUTION IMAGE COULD BE OBTAINED. THE IMAGE REVEALED THAT THE SUTURE TIP WAS RETAINED IN THE SUPERFICIAL SKIN LAYER. THE PHYSICIAN BROUGHT THE PATIENT BACK TO THE EP (ELECTROPHYSIOLOGY) LAB SUITE, OPENED THE POCKET, LOCATED THE SUTURE NEEDLE TIP AND REMOVED IT. THE PACEMAKER POCKET WAS CLOSED WITH A NEW SUTURE, STERI-STRIPS, A TOPICAL SKIN ADHESIVE, AND A BAND-AID WITHOUT INCIDENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21157869 ↗
• MalfunctionAug 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE PER USER FACILITY MEDWATCH FORM # (B)(4), AT THE END OF THE SURGICAL PROCEDURE, THE SURGEON WAS CLOSING UMBILICAL ROBOTIC LAP SITE WITH SUTURE, WHEN THE NEEDLE PART OF THE SUTURE BROKE INTO TWO PIECES. BOTH PIECES OF THE NEEDLE WERE RETRIEVED AND DISCARDED. THERE WAS NO HARM TO THE PATIENT. ANOTHER NEEDLE WAS USED TO SUTURE THE SITE. BROKEN NEEDLE WAS DISCARDED. THE DEVICE WAS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19950017 ↗
• MalfunctionJun 7, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURE WAS DEFECTIVE. IT WAS NOTICED ON THE BACK TABLE THAT THE SUTURE WAS DOUBLE-ARMED. THERE WAS NO PATIENT HARM REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19482136 ↗
• MalfunctionApr 19, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED ON THE SKIN. THE DOCTOR WAS CLOSING AND THE NEEDLE BROKE RIGHT IN HALF WHEN PASSING IT THROUGH THE SKIN. HE JUST HAD TO OPEN A NEW ONE. NO ADVERSE EVENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19148166 ↗
• MalfunctionApr 16, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. THE NEEDLE DETACHES FROM THE SUTURE AND ONE WAS REMOVED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19115780 ↗
• MalfunctionMar 29, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. IT WAS NOTICED THAT PART OF THE NEEDLE WAS BROKEN OFF STILL ATTACHED TO THE SUTURE. THE CUSTOMER NOTICED THE NEEDLE AND REMOVED THE SUTURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19006004 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. THE SUTURE PULLED OUT OF THE SWEDGE OF THE NEEDLE. TWO STRANDS FROM THE SAME LOT WERE ATTEMPTED WITH THE SAME OUTCOME. ANOTHER LIKE SUTURE FROM A DIFFERENT LOT WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO DEVICES RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841934 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. THE SUTURE PULLED OUT OF THE SWEDGE OF THE NEEDLE. TWO STRANDS FROM THE SAME LOT WERE ATTEMPTED WITH THE SAME OUTCOME. ANOTHER LIKE SUTURE FROM A DIFFERENT LOT WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO DEVICES RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841471 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. THE SUTURE PULLED OUT OF THE SWEDGE OF THE NEEDLE. TWO STRANDS FROM THE SAME LOT WERE ATTEMPTED WITH THE SAME OUTCOME. ANOTHER LIKE SUTURE FROM A DIFFERENT LOT WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO DEVICES RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841153 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. THE SUTURE PULLED OUT OF THE SWEDGE OF THE NEEDLE. TWO STRANDS FROM THE SAME LOT WERE ATTEMPTED WITH THE SAME OUTCOME. ANOTHER LIKE SUTURE FROM A DIFFERENT LOT WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO DEVICES RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841150 ↗
• MalfunctionNov 28, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A PERINEAL LACERATION ON (B)(6) 2023 AND SUTURE WAS USED. THE 3-0 SINGLE SUTURE NEEDLE BROKE OFF FROM THE SUTURE AND BECAME LODGED IN THE PATIENT'S PERINEUM. PROVIDER HAD TO UNDO THE PROGRESS OF HER REPAIR TO FIND THE NEEDLE IN THE PATIENT'S PERINEUM. THE NEEDLE WAS REMOVED BY PROVIDER AND WAS INTACT. PERINEAL REPAIR WAS FINISHED WITH 3-0 DOUBLE NEEDLE SUTURE WITH NO COMPLICATIONS.¿ THE DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18215412 ↗
• MalfunctionNov 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP HERNIA REPAIR PROCEDURE ON 10/31/2023, AND SUTURE WAS USED. A NON POP OFF SUTURE POPPED OFF. THE CASE COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212873 ↗
• MalfunctionOct 25, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OBSTETRICS PROCEDURE IN 2023 AND SUTURE WAS USED. DURING AN OBSTETRICS PROCEDURE THE NEEDLE BROKE OFF AND THEY WERE NOT ABLE TO LOCATE IT UNTIL AN X-RAY WAS MADE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004868 ↗
• InjuryMay 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON WAS SEWING A VESSEL IN DEEP TISSUE IN THE PERINEUM, THE SURGEON GRASPED THE SUTURE TO PULL IT THROUGH THE TISSUE THE TIP OF THE SUTURE BROKE OFF AND FELL INTO THE PATIENT'S WOUND. THE SUTURE NEEDLE PIECE WAS NOT ABLE TO BE RETRIEVED FROM THE PATIENT'S BODY AND REMAINS IN IT. AN XRAY AND ULTRASOUND WERE DONE TO TRY TO RETRIEVE THE NEEDLE FRAGMENT, BUT IT WAS UNABLE TO BE REMOVED. THE WOUND WAS LEFT OPEN TO HEAL SECONDARILY. THE PATIENT WAS PRESCRIBED A 5 DAY COURSE OF ORAL CIPRO/FLAGYL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16947336 ↗
• MalfunctionMar 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A 3C EPISIOTOMY REPAIR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS GIVEN TO THE MD AND A STITCH WAS ATTEMPTED. THE METAL NEEDLE BROKE IN TWO IN THE PATIENT'S TISSUE. THE PHYSICIAN HAD A DIFFICULT TIME TRYING TO FIND THE BROKEN PIECE, BUT THE NEEDLE PIECE(S) WERE RETRIEVED DURING THE SAME PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16611883 ↗
• MalfunctionMar 1, 2023Break

  THE PHYSICIAN REQUESTED A 3-0 VICRYL SUTURE ON AN SH NEEDLE (J416H) FOR A 3C EPISIOTOMY REPAIR. THE SUTURE WAS GIVEN TO THE MD AND A STITCH WAS ATTEMPTED. THE METAL NEEDLE BROKE IN TWO IN THE PATIENT'S TISSUE. THE PHYSICIAN HAD A DIFFICULT TIME TRYING TO FIND THE BROKEN PIECE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16459114 ↗
• MalfunctionJan 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. ONE OF THE GYN ONCOLOGISTS HAS HAD SOME RECENT NEEDLES BREAKING. THE OR STAFF STATED THAT BOTH NEEDLES THAT BROKE CAME FROM THE SAME BOX, SO THEY PULLED IT ASIDE NOT TO GET USED AGAIN. THEY WERE ABLE TO RETRIEVE THE PIECES AND NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16237638 ↗
• MalfunctionJan 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. ONE OF THE GYN ONCOLOGISTS HAS HAD SOME RECENT NEEDLES BREAKING. THE OR STAFF STATED THAT BOTH NEEDLES THAT BROKE CAME FROM THE SAME BOX, SO THEY PULLED IT ASIDE NOT TO GET USED AGAIN. THEY WERE ABLE TO RETRIEVE THE PIECES AND NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16237633 ↗
• InjuryNov 8, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEMORRHOIDECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF IN THE TISSUE. WHEN SUTURE WAS REMOVED, 2MM OF THE NEEDLE WAS STILL ATTACHED TO THE SUTURE. THE BROKEN PIECE OF THE NEEDLE WAS NOT RECOVERED. X-RAYS WERE TAKEN AND THE NEEDLE COULD BE SEEN BUT THEY WERE NOT ABLE TO REMOVE IT FROM THE TISSUE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15756267 ↗
• MalfunctionSep 28, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE FELL OFF THE NEEDLE WHEN STARTING TO SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15498341 ↗
• MalfunctionAug 4, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE TIP OF THE NEEDLE BROKE OFF DURING THE SUBCUTICULAR CLOSURE. X-RAY WAS DONE AND THE TIP COULD BE SEEN BUT THE SURGEON WAS UNABLE TO RETRIEVE IT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15170144 ↗
• MalfunctionJun 14, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. IT WAS RETRIEVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14690130 ↗
• MalfunctionMar 15, 2022Material 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 NEEDLE GOT DETACHED FROM THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13766279 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269, K183183. One submission often covers many models, so check the product and lot details in each record.

• Z-1513-2025 · Mar 7, 2025 · Open, Classified
  PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
• Z-0319-2025 · Sep 25, 2024 · Open, Classified
  Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
• Z-2146-2024 · May 10, 2024 · Open, Classified
  PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery.
• 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