Coated VICRYL VCP352H (UDI 10705031052635)Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10705031052635), received between Jan 7, 2020 and Oct 27, 2025 — classified as 15 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, MEDICAL TEAM (MATERNITY MEDICAL MANAGER) REPORTS THAT HE AND OTHER TEAMS NOTICED A DIFFERENCE IN THE STRUCTURE OF THE SUTURES (THINNER) THAN USUAL. THE SAME QUESTIONS WHETHER THERE WAS ANY CHANGE OR CHANGE IN OUR MAKING, SUCH AS: THREAD LOCK, CLOSURE, COMPOSITION. OR SOMETHING THAT MAY HAVE THIS PERCEPTION NOTICED BY THEM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392141 ↗
• MalfunctionOct 27, 2025Product Quality Problem; Defective Component; Product Quality Problem; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, MEDICAL TEAM (MATERNITY MEDICAL MANAGER) REPORTS THAT HE AND OTHER TEAMS NOTICED A DIFFERENCE IN THE STRUCTURE OF THE SUTURES (THINNER) THAN USUAL. THE SAME QUESTIONS WHETHER THERE WAS ANY CHANGE OR CHANGE IN OUR MAKING, SUCH AS: THREAD LOCK, CLOSURE, COMPOSITION. OR SOMETHING THAT MAY HAVE THIS PERCEPTION NOTICED BY THEM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392111 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE STRANDS WERE CONTINUOUSLY BROKEN WHEN LIGATING. 10 OF 6 SUTURE WERE NOT IN THE PACKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153179 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE STRANDS WERE CONTINUOUSLY BROKEN WHEN LIGATING. 10 OF 6 SUTURE WERE NOT IN THE PACKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153067 ↗
• MalfunctionOct 31, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NURSE FOUND THAT THERE HAD BEEN FOREIGN MATTER IMMEDIATELY ONCE OPENED THE PACKAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20579775 ↗
• MalfunctionOct 16, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. AT 23:17 PM, THE PATIENT UNDERWENT SURGERY DUE TO FETAL ACTIVE PERIOD STAGNATION. THE SURGERY WENT SMOOTHLY, THE FETUS WAS DELIVERED SMOOTHLY, AND THE SUTURE WAS SUTURED LAYER BY LAYER. AT 0:15, THE DOCTOR SUTURED THE TENDON SHEATH LAYER WITH SUTURE. WHEN THE 8TH STITCH WAS SUTURED, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. AFTER CAREFUL INSPECTION OF THE SUTURE NEEDLE, IT WAS FOUND THAT THE NEEDLE TAIL WAS ABOUT 1MM MISSING. THE NEEDLE FINDER WAS REPEATEDLY USED TO FIND IT, AND THE SUTURE SURFACE WAS TOUCHED BY HAND TO FIND IT, BUT NO BROKEN NEEDLE WAS FOUND. CONSIDERING THAT THE 1MM BROKEN NEEDLE COULD NOT BE FOUND AND LOCATED BY THE BEDSIDE MACHINE, AND THE PATIENT HAD CLOSED THE ABDOMEN LAYER BY LAYER TO THE TENDON SHEATH LAYER, THE INCISION WAS REPEATEDLY RINSED WITH SALINE AND FINALLY CLOSED. THE BROKEN NEEDLE DELAYED THE OPERATION PROCESS BY ABOUT 40 MINUTES, INCREASED THE RISK OF INFECTION FOR THE PATIENT, AND CAUSED ANXIETY TO THE MEDICAL STAFF. DURING THE SURGERY, THE SUTURE WAS USED ACCORDING TO THE INSTRUCTIONS, AND THERE WERE NO SITUATIONS SUCH AS CLAMPING THE NE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461468 ↗
• MalfunctionApr 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6) 2024, AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR THE SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134652 ↗
• MalfunctionFeb 2, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636590 ↗
• MalfunctionOct 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE DOCTOR FOUND OUT THE SUTURE THREAD DETACHED FROM THE NEEDLE WHEN HE WAS SUTURING WITH IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17956428 ↗
• MalfunctionOct 4, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. AT 2:30 PM, THAT THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED WHEN SUTURING THE WOUND OF THE PATIENT. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17868766 ↗
• MalfunctionApr 10, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2023 AND SUTURE WAS USED. IT WAS FOUND THAT THERE HAD BEEN 3CM HAIR IN THE NEWLY DISPENSED SUTURE, WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENTS INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16707355 ↗
• MalfunctionJan 27, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE NEEDLE WAS USED FOR AN OPEN MYOMECTOMY CASE DURING CLOSURE OF THE UTERINE WOUND AND FOUND A 4MM TIP WAS BROKEN AND MISSING RIGHT AFTER THE SURGEON RETURNED THE NEEDLE BACK TO SCRUB NURSE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16258969 ↗
• MalfunctionOct 27, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE DURING SEWING UTERINE INCISION AND THE NEEDLE BROKE. 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 15680105 ↗
• InjurySep 12, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2022 AND SUTURE WAS USED TO SUTURE THE ANTERIOR SHEATH OF RECTUS ABDOMINIS. POST-OP, ON THE FIRST DAY AFTER SURGERY AT 10AM, THE DOCTOR FOUND THAT THERE WAS EXUDATION ON THE LEFT SIDE OF THE ABDOMINAL INCISION WITH RED BLOOD, ABOUT 15ML. THE DOCTOR CHANGED THE DRESSING FOR THE PATIENT'S WOUND AND APPLY PRESSURE BANDAGE. AT 5:00 P.M. ON THE FIRST DAY AFTER THE SURGERY, BECAUSE THE PATIENT'S WOUND WAS SPLIT, THE ABDOMINAL WALL INCISION WAS SUTURED TWICE UNDER THE ABDOMINAL WALL NERVE BLOCK. DURING THE SURGERY, IT WAS FOUND THAT THE SUTURE OF THE ANTERIOR SHEATH WAS BROKEN FROM 1 / 3 OF THE RIGHT INCISION, AND BLOOD EXUDATE WAS SEEN LOCALLY. AFTER CLEANING THE WOUND WITH NORMAL SALINE, THE WOUND WAS SUTURED LAYER BY LAYER, AND THE ABSORBABLE THREAD WAS CONTINUOUSLY SUTURED. AFTER THE SURGERY , THE PATIENT RETURNED TO THE WARD SAFELY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Wound Dehiscence

  MAUDE report 15400997 ↗
• MalfunctionJul 11, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE INCIDENT HAPPENED DURING THE CLOSING OF SECOND LAYER OF UTERUS. THE SCRUB NURSE NOTICED THE NEEDLE IS INCOMPLETE (NO TIP). SURGEON WAS INFORMED DIRECTLY. THEY LOOKED FOR THE TIP IN THE PATIENT ABDOMEN CAVITY OR TABLE AND FLOOR, WHERE TO BE FOUND, AND NO NEEDLE FOUND. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14983413 ↗
• MalfunctionJul 11, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE INCIDENT HAPPENED DURING THE CLOSING OF SECOND LAYER OF UTERUS. THE SCRUB NURSE NOTICED THE NEEDLE IS INCOMPLETE (NO TIP). SURGEON WAS INFORMED DIRECTLY. THEY LOOKED FOR THE TIP IN THE PATIENT ABDOMEN CAVITY OR TABLE AND FLOOR, WHERE TO BE FOUND, AND NO NEEDLE FOUND. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14983412 ↗
• MalfunctionJun 7, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE WHILE SEWING A FAT LAYER IN THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14623009 ↗
• MalfunctionJun 6, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2021 AND SUTURE WAS USED. DURING USE ON THE PATIENT IT WAS NOTED THAT THE NEEDLE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THE MISSING PART COULD NOT BE FOUND OR DISCOVERED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14602522 ↗
• InjuryMay 25, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2022 AND SUTURE WAS USED. POST-OP, THE PATIENT HAD POOR WOUND HEALING. ON (B)(6) 2022, IT WAS FOUND THAT THERE WAS EXUDATION OF BLOODY FLUID DURING EXTRUSION FROM THE INCISION, THEN GAUZE STRIP DRAINAGE WAS GIVEN AND THE INCISION DRESSING WAS CHANGED. ON (B)(6) 2022, THERE WAS STILL BLOODY FLUID, ALSO DEBRIDEMENT AND DRESSING CHANGE WERE PERFORMED. ON (B)(6) 2022, THE PATIENT UNDERWENT DEBRIDEMENT AND SUTURING SURGERY OF ABDOMINAL INCISION, AND THE SUTURE OF THE ANTERIOR SHEATH OF THE ORIGINAL ABDOMINAL INCISION WAS FOUND BROKEN. THEN THE ANTERIOR SHEATH WAS SEWED AGAIN WITH SILK SUTURE. THE CURRENT CONDITION OF THE PATIENT WAS REPORTED AS DISCHARGED SMOOTHLY. NO ADDITIONAL INFORMATION AS PROVIDED.

  Patient problems: Fluid Discharge; Insufficient Information

  MAUDE report 14497968 ↗
• MalfunctionMay 9, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE PULLED OFF OF THE NEEDLE IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14340497 ↗
• MalfunctionFeb 23, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF HUMERAL FRACTURE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. BEFORE USE ON PATIENT, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. UPON EVALUATION OF THE RETURNED SAMPLE, A SHORT INSERTION WAS OBSERVED IN THE STRAND. THE VISUAL INSPECTION CONCLUDED THAT THE COMBINATION OF THE NEEDLE/SUTURE WAS FOUND DETACHED SINCE THE INSERTION END OF THE SUTURE DID NOT MEET THE REQUIREMENT. THE DEFECT IS CAUSED BECAUSE THE SUTURE WAS NOT PROPERLY INSERTED INSIDE OF THE NEEDLE BARREL HOLE RESULTING IN A PULL-OUT DEFECT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13585707 ↗
• MalfunctionDec 10, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. WHILE SUTURING THE NEEDLE TIP BROKE AND IT IS SUSPECTED IT STILL INSIDE THE PATIENT ABDOMEN. THE PROCEDURE WAS DELAYED 30 MINUTES IN ORDER TO DO MORE EXPLORATION TO TRY TO FIND THE TIP. THE TIP WAS NOT FOUND, AND THE PATIENT WAS CLOSED. THE PATIENT WENT FOR AN X-RAY. THERE ARE NO PLANS TO REMOVE THE SUSPECTED RETAINED NEEDLE. THERE WERE NO UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12976934 ↗
• MalfunctionSep 21, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYSTEROSUSPENSION ON (B)(6) 2021 AND A SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AFTER ENTERING THE PELVIS, THE NEEDLE COULD NOT BE FOUND. AFTER REPEATED FLUOROSCOPY WITH A C-ARM, THE IMAGE WAS FOUND ONE AND A HALF HOURS LATER, THE NEEDLE WAS FOUND AND REMOVED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12505422 ↗
• MalfunctionMay 20, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860528 ↗
• MalfunctionFeb 11, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT C-SECTION ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING DURING THE SURGERY. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11316022 ↗

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