Coated VICRYL VCP317H (UDI 10705031052253)Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 10705031052253), received between Feb 5, 2018 and Sep 23, 2026 — classified as 30 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Break” (29 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 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Material Separation

  It was reported that a patient underwent an Iliac artery stent implantation+lower limb angiography+iliac artery balloon angioplasty procedure on (b)(6)2026 and suture was used. The cardiovascular surgeon sutured the patient after surgery. The doctor opened the suture and found that the needle and suture were separated and unusable. The doctor immediately replaced the suture with a new one and continued suturing. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872719 ↗
• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC PARTIAL NEPHRECTOMY ON(B)(6) 2017 AND SUTURE WAS USED. DURING THE PROCEDURE, A SURGICAL NEEDLE WAS INADVERTENTLY RETAINED. THE PATIENT HAD A TOMOGRAPHY/CT SCANS PERFORMED IN (B)(6) 2018 AND 2020 WHICH CONFIRMED THE PRESENCE OF A CURVED METAL STRUCTURE (HALF-MOON SHAPE), RADIOPAQUE, WITH ABOUT 2.5 CM IN THE LARGEST AXIS, HOUSED NEAR THE LOWER POLE OF THE RIGHT KIDNEY AND ENCAPSULATED BY FIBROSIS, WITHOUT MOBILITY. FROM THE LIST OF MATERIALS USED IN THE SURGERY, THE NEEDLE CORRESPONDS, WITH A HIGH PROBABILITY, TO THE CT-1 NEEDLE. THE PATIENT CURRENTLY NEEDS TO CHECK IF SHE CAN HAVE AN MRI SCAN SAFELY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25689948 ↗
• MalfunctionJun 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE OPERATION OF SUTURING THE SKIN, THE SUTURE SUDDENLY BROKE. IMMEDIATELY REPLACED IT WITH A NEW ONE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25427887 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED. THE NEEDLE BROKE WHEN SEWING IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE LOT NUMBER IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24997952 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLATING AND SCREW FIXATION SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT HAD A BICYCLE ACCIDENT ON (B)(6) 2025 AND EXPERIENCED FRACTURES OF THE LATERAL, TIBIAL, AND SINUS JOINTS. ON (B)(6) 2025, THE SUTURES WERE REMOVED. ON (B)(6) 2025, THE STAPLES WERE REMOVED. ON (B)(6) 2025, NODULAR FRAGMENTS OF SUTURE MATERIAL WERE VISIBLE ALONG THE INCISION OVER A LENGTH OF 1 CM ¿ TREATED WITH HONEY ONCE. ON (B)(6) 2025, THE PATIENT WAS HEALED. IT WAS REPORTED THAT THE PATIENT REQUIRED LASERTHERAPIE. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS GOOD. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Local Reaction; Pocket Erosion

  MAUDE report 24713020 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLATING AND SCREW FIXATION SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT HAD A BICYCLE ACCIDENT ON (B)(6) 2025 AND EXPERIENCED FRACTURES OF THE LATERAL, TIBIAL, AND SINUS JOINTS. ON (B)(6) 2025, THE SUTURES WERE REMOVED. ON (B)(6) 2025, THE STAPLES WERE REMOVED. ON (B)(6) 2025, NODULAR FRAGMENTS OF SUTURE MATERIAL WERE VISIBLE ALONG THE INCISION OVER A LENGTH OF 1 CM ¿ TREATED WITH HONEY ONCE. ON (B)(6) 2025, THE PATIENT WAS HEALED. IT WAS REPORTED THAT THE PATIENT REQUIRED LASER THERAPIE. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS GOOD. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Local Reaction; Pocket Erosion

  MAUDE report 24712883 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE DUE TO BIMALLEOLAR FRACTURE THAT OCCURRED ON (B)(6) 2025. THE SURGERY TOOK PLACE ON (B)(6) 2025 WITH SCREWS AND PLATES AND SUTURE WAS USED. COURSE: ON (B)(6): ITCHING REACTION TO DRESSING ¿ SUSPECTED ALLERGY TO ADHESIVE BANDAGE. ON (B)(6): SUTURE REMOVAL ¿ SUBSEQUENT APPLICATION OF STERI-STRIPS/BLISTERS FORMING NEXT TO THE SUTURE. ON (B)(6): PROXIMAL HEMATOMA DRAINED ¿ APPLICATION OF A PICCO-VAC DRESSING. ON (B)(6): AT THE DISTAL END OF THE INCISION, OVER 4 CM IN LENGTH, TWO RETRACTED AREAS OF THE SUTURE LINE ARE VISIBLE/CLEAR SIGNS OF INFLAMMATION WITH REDNESS AND SWELLING ARE VISIBLE ON (B)(6): IDENTICAL CONDITION TO ON (B)(6) 2025. ON (B)(6): REDUCTION OF INFLAMMATION ¿ TREATMENT WITH BETADINE. ON (B)(6): REDUCING INFLAMMATION ¿ TREATMENT WITH BETADINE. ON (B)(6): WOUND SHOWS SIGNS OF HEALING ¿ SILVER ALGINATE DRESSING. ON (B)(6): CONTINUED SIGNS OF HEALING. ON (B)(6): HEALING OF THE DISTAL AREA / REGARDING THE SUTURE ISSUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Fluid Discharge; Hematoma; Inflammation; Swelling/ Edema; Wound Dehiscence

  MAUDE report 24405824 ↗
• MalfunctionDec 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. AS THE REGISTRAR WAS RELOADING A SUTURE, THE TIP BROKE OFF. THE TIP WAS FOUND ATTACHED TO THE FORCEPS. THE SURGEON CONFIRMED ALL COMPONENTS OF THE SUTURE WERE RECOVERED. THE INCIDENT OCCURRED OVER THE STERILE FIELD BUT NOT OVER THE WOUND. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742938 ↗
• MalfunctionNov 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT LYMPH NODE BIOPSY SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE HOLDERS WERE RETURNED TO THE INSTRUMENTALIST WHEN THE SUBCUTANEOUS WAS CLOSED. THE INSTRUMENTALIST, WHEN CLEANING AND LOADING THE NEEDLE HOLDER ITSELF FOR THE SUBSEQUENT SKIN SUTURES, NOTICED THE PRESENCE OF THE NEEDLE TIP (PREVIOUSLY USED) BETWEEN THE NEEDLE HOLDER LEGS. USED ANOTHER DEVICE. NEEDLE BREAKAGE. NO PROBLEMS PER PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658396 ↗
• MalfunctionNov 11, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS FOUND DETACHED FROM THE SUTURE WHEN THE STAFF OPENED A NEW PACKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524140 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR RESECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. AFTER REMOVING NEEDLE AND SUTURE FROM RELAY PACKET AND LOADING WITH NEEDLE DRIVER, THE NURSE NOTED THE TIP OF THE NEEDLE ON TROLLEY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442742 ↗
• MalfunctionMay 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021700 ↗
• MalfunctionMar 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON WAS DOING THE SUTURING KNOT, SURGEON REALIZED THAT THE SUTURE BECAME BRITTLE AND SNAPPED. THE ACTUAL SUTURE USED WILL BE RETURNED FOR INVESTIGATION. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21654376 ↗
• MalfunctionMar 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, MISSING TIP OF SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606028 ↗
• MalfunctionFeb 25, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SIGMOID COLECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE RUPTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21463096 ↗
• MalfunctionNov 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20617079 ↗
• MalfunctionOct 3, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT SUTURE DEGRADATION WAS OBSERVED. IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING PLASTIC SURGERY, THE MOMENT THE PRIMARY CONTAINER OF THE SUTURE IS OPENED, THE SURGEON NOTICES THAT THE NEEDLE IS DETACHED FROM THE THREAD, SO HE REQUESTS TO CHANGE IT FOR ONE IN GOOD CONDITION. THERE WERE NO PROBLEMS IN THE PATIENT AND THE TIME OF SURGERY WAS LENGTHENED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358066 ↗
• MalfunctionApr 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS RELEASED FROM THE SUTURE WHEN PASSING THE FIRST STITCH. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19127946 ↗
• MalfunctionJan 18, 2024Material Separation; Material Separation

  IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT SUTURE DEGRADATION WAS OBSERVED, THE SUTURES CANNOT BE DISPENSED SINCE THEY HAVE BEGUN THE DEGRADATION PROCESS. THIS CONDITION CAUSES THE NEEDLE TO BE DETACHED FROM THE SUTURE. IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN OCTOBER 2023 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED BEFORE USING ON PATIENT DURING SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535164 ↗
• MalfunctionJan 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UMBILICAL HERNIA PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE BROKE ON THE SECOND PASS, THE SECOND TIME NEEDLE DRIVERS WERE CLAMPED ON THE NEEDLE, WHEN FIXATING THE MESH. THE NEEDLE BROKE BETWEEN THE 1/3 TO 1/2 POINT OF THE NEEDLE DISTAL TO THE SWAGE. NEEDLE FELL INTO THE PATIENT'S ABDOMINAL CAVITY BUT WAS SUCCESSFULLY RETRIEVED. THE SURGERY WAS DELAYED 2 MIN. COMPLETED THE PROCEDURE SUCCESSFULLY WITH ANOTHER LIKE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18508596 ↗
• MalfunctionJan 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL TEAR REPAIR ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE VAGINA. DURING THE PROCEDURE, WHEN SUTURE WAS HANDED BACK TO SCRUB NURSE BY SURGEON AFTER USE, THE TIP OF THE NEEDLE WAS MISSING. THE SURGICAL SITE WAS INSPECTED BY THE SURGEON, WHO WAS UNABLE TO FIND THE NEEDLE POINT AS IT WAS VERY TINY. NO X-RAYS WERE TAKEN. THERE ARE NO PLANS IN PLACE TO REMOVE THE NEEDLE PIECE IN THE FUTURE AS IT WAS NOT IDENTIFIED AS BEING RETAINED IN THE TISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18449784 ↗
• MalfunctionDec 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KIDNEY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER COMPLAINS OF INSUFFICIENT STRENGTH OF THE THREAD CONNECTION TO THE NEEDLE. THE NEEDLE FALLS OFF DURING THE SUTURE WHEN PROPERLY HELD IN THE NEEDLE HOLDER. THE CONNECTION IS NOT STRONG ENOUGH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369040 ↗
• MalfunctionNov 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PYELOPLASTY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, DURING THE PYELOPLASTY PROCEDURES, DR EXPERIENCE SUTURE SNAPPED INTRA-OP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18079045 ↗
• MalfunctionOct 31, 2023Device Markings/Labelling Problem; Component Misassembled; Device Markings/Labelling Problem; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS FOUND IN THE CITY OF BARQUISIMETO A COMPLAINT WHERE THEY BOUGHT A 2-0 VICRYL FOR A SURGERY PERFORMED ON FRIDAY, (B)(6) ACCORDING TO THE ENVELOPE, AND WHEN THEY OPEN THE ENVELOPE IN THE OPERATING ROOM, THE BLISTER THAT COMES INSIDE IS 3-0 VICRYL, THE ENVELOPE IT IS VISIBLY A FAKE, THE 3-0 BLISTER SEEMS REAL, HOWEVER WE ASSUME THAT IT IS EXPIRED AND THEY INSERT IT INTO SUPPOSEDLY VALID ENVELOPES (WE ATTACH PHOTOS). NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18040698 ↗
• MalfunctionOct 31, 2023Device Markings/Labelling Problem; Component Misassembled; Device Markings/Labelling Problem; Component Misassembled

  IT WAS FOUND IN THE CITY OF BARQUISIMETO A COMPLAINT WHERE THEY BOUGHT A 2-0 VICRYL FOR A SURGERY PERFORMED ON FRIDAY, SEPTEMBER 29, ACCORDING TO THE ENVELOPE, AND WHEN THEY OPEN THE ENVELOPE IN THE OPERATING ROOM, THE BLISTER THAT COMES INSIDE IS 3-0 VICRYL, THE ENVELOPE IT IS VISIBLY A FAKE, THE 3-0 BLISTER SEEMS REAL, HOWEVER WE ASSUME THAT IT IS EXPIRED AND THEY INSERT IT INTO SUPPOSEDLY VALID ENVELOPES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18040004 ↗

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