Coated VICRYL VCP316H (UDI 10705031052239)Recalls & reported problems

Summary

The FDA's MAUDE database contains 146 adverse event reports that list this exact device (DI 10705031052239), received between Feb 7, 2018 and Sep 24, 2026 — classified as 22 injuries, 124 malfunctions.

The most frequently reported specific device problem is “Break” (62 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 25 most recent of 146 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890065 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a surgery on the right colon on (b)(6) 2026 and suture was used. The patient underwent a revision surgery on (b)(6) 2026 because the anastomosis completely disunited, the thread seemed rejected. A suture not coated with triclosan was used during the surgical resumption on (b)(6). There was a total absence of healing 10 days after surgery. It was stated there was a serious deterioration of health with a fistula and a surgical resumption with temporary stoma. Temporary deletion of baseline. There were no risk factors identified in the patient. The patient was discharged on (b)(6) 2026. Additional information was requested.

  Patient problems: Fistula; Impaired Healing; Wound Dehiscence

  MAUDE report 50325434 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a surgery on the right colon on (b)(6) 2026 and suture was used. The patient underwent a revision surgery on (b)(6) 2026 because the anastomosis completely disunited, the thread seemed rejected. A suture not coated with triclosan was used during the surgical resumption on (b)(6). There was a total absence of healing 10 days after surgery. It was stated there was a serious deterioration of health with a fistula and a surgical resumption with temporary stoma. Temporary deletion of baseline. There were no risk factors identified in the patient. The patient was discharged on (b)(6) 2026. Additional information was requested.

  Patient problems: Fistula; Impaired Healing; Wound Dehiscence

  MAUDE report 50325428 ↗
• MalfunctionApr 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LOWER SEGMENT CESAREAN SECTION PROCEDURE ON (B)(6) 2026 SUTURE WAS USED. AFTER THE DELIVERY OF THE BABY AND PLACENTA, THE DOCTOR USED SUTURE TO SUTURE THE PATIENT'S UTERUS, BUT THE SUTURE AND NEEDLE SUDDENLY BROKE. IMMEDIATELY STOP USING AND REPLACE WITH NEW SUTURE OF THE SAME ORIGIN, MODEL, AND BATCH NUMBER. IN SUBSEQUENT OPERATIONS, NO SIMILAR ISSUES WERE FOUND WITH THE SAME BATCH OF PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889183 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BREAST REDUCTION SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. AT THE POSTOPERATIVE FOLLOW-UP, THE SUTURES ARE REMOVED FROM THE RIGHT AREOLA DUE TO EXTRUSION. APPLY HEALING CREAM AND THEN PERFORM VIGOROUS SCAR MASSAGE. MEDICAL OR SURGICAL INTERVENTION IS REQUIRED TO PREVENT PERMANENT DAMAGE TO A STRUCTURE OR BODILY FUNCTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 24709251 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR INSERTED THE BONE ANCHORED DEVICE UNDER THE PERIOST AND SUTURED IT WITH SUTURES AS WELL AS THE SUBCUTANEOUS TISSUE. AFTER A MONTH A LARGE DEHISCENCE FORMED WITH PARTIAL NECROSIS OF THE SKIN. THE DOCTOR WHO REPORTED THE EVENT INQUIRED WHETHER THAT COULD BE CAUSED BY AN ALLERGY TO THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Necrosis; Wound Dehiscence

  MAUDE report 24513856 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR INSERTED THE BONE ANCHORED DEVICE UNDER THE PERIOST AND SUTURED IT WITH SUTURES AS WELL AS THE SUBCUTANEOUS TISSUE. AFTER A MONTH A LARGE DEHISCENCE FORMED WITH PARTIAL NECROSIS OF THE SKIN. THE DOCTOR WHO REPORTED THE EVENT INQUIRED WHETHER THAT COULD BE CAUSED BY AN ALLERGY TO THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Necrosis; Wound Dehiscence

  MAUDE report 24513711 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS EASILY CUT DURING USING THE PRODUCTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555603 ↗
• InjuryNov 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANAL FISTULA SURGERY ON (B)(6) 2025 AND 5 DAYS AFTER SURGERY, THE PATIENT EXPERIENCED SUDDEN ACTIVE BLEEDING. THE PATIENT WAS SUTURED IN THE WARD ON (B)(6) 2025 TO STOP THE BLEEDING. DURING THE SUTURING PROCESS, THE NEEDLE BROKE IN THE PATIENT'S BODY. THE EMERGENCY CT CONFIRMED THE LOCATION, AND THE BROKEN NEEDLE WAS SURGICALLY TAKEN OUT ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23467898 ↗
• MalfunctionAug 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO TIE A KNOT WITH SUTURE. 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 22906918 ↗
• MalfunctionJun 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OVARIAN RADICAL SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. WHEN THE DOCTOR NEEDED TO SUTURE DURING THE OPERATION, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, MAKING IT IMPOSSIBLE FOR THE DOCTOR TO USE SUTURE NORMALLY. AFTER REPLACING THE SUTURE, THE SURGERY CONTINUED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298983 ↗
• MalfunctionJun 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. AFTER CONTACTING THE MANUFACTURER, IT WAS REPLIED THAT DURING THE VISUAL INSPECTION OF THE SEPARATED NEEDLE, TRACES CAUSED BY SURGICAL TOOLS WERE NOTICED IN THE FORGING AREA AND HOLES. UNDER A MAGNIFYING GLASS, IT WAS OBSERVED THAT THERE WERE RESIDUAL SUTURES INSIDE THE HOLE. IN ADDITION, UPON INSPECTION OF THE SUTURE, IT WAS FOUND THAT THE END CUT MAY HAVE BEEN CAUSED BY SURGICAL TOOLS. THE USER MANUAL INCLUDES THE FOLLOWING PRECAUTIONS: TO AVOID SUCH DAMAGE, GRAB THE NEEDLE IN THE AREA FROM ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE CONNECTION END TO THE NEEDLE TIP. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22154380 ↗
• InjuryMay 13, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT HAD A LEAK FROM HIS SMALL BOWEL WITH A COLLECTION ON HIS RIGHT PSOAS. THIS WAS DRAINED (B)(6) 2025 WITH ENTERIC CONTENTS. HE IS BEING MANAGED CONSERVATIVELY FOR HIS ENTERIC LEAK WITHOUT A RELOOK LAPAROTOMY. HOWEVER, HE HAS HAD FURTHER COMPLICATIONS WITH A CODE BLUE THIS MORNING NEEDING FURTHER IR INTERVENTIONS. THE SURGEON HAS NOTICED THAT THE SUTURE WAS MORE COARSE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Perforation

  MAUDE report 22014983 ↗
• InjuryMay 1, 2025Defective Component; Defective Component

  THE IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED TO ANASTOMOSE BOWEL. IT WAS FOUND TO HAVE A SERRATED TEXTURE INSTEAD OF SMOOTH. THIS RESULTED IN THE BOWEL BEING CUT BY THE PASSING OF THE SUTURE THROUGH THE TISSUE MUCH LIKE A SAW BLADE. THE PATIENT WAS TAKEN BACK TO THE OT 2 DAYS AFTER FOR A DUODENAL LEAK. SHE HAD A SEROSAL TEAR TO THE DUODENUM WHICH WAS OVERSEWN WITH THE FAULTY SUTURE AND HAD A FULL THICKNESS TEAR TO THE DUODENUM ON THE RE-LOOK. SHE HAD THE INJURY OVERSEWN ON THE 3RD APRIL DURING THE TAKE BACK AND POST-OPERATIVE COMPLICATIONS HAVE INCLUDED SEPSIS AND RAPID ATRIAL FLUTTER NEEDING RE-ADMISSION TO ICU UNTIL 16TH APRIL. SHE HAS ALSO HAD A PROLONGED PERIOD OF NBM (NIL BY MOUTH) DUE THE LEAK AND NEEDED TPN FOR THAT DURATION. THERE WAS NOT A SUBSTANTIAL BLOOD LOSS AT THE TAKE BACK (I WOULD ESTIMATE ONLY 200ML). ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Atrial Flutter; Perforation; Sepsis

  MAUDE report 21946365 ↗
• MalfunctionJan 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A OB-GYN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM SUTURE WHEN SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21258783 ↗
• MalfunctionJan 8, 2025Material 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 SWAGE AFTER DOCTOR MAKING THE FIRST BITE ON TISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21100247 ↗
• MalfunctionDec 31, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE COMES LOOSE FROM THE THREAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047328 ↗
• MalfunctionNov 21, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE KEEPS COMING OFF THE NEEDLE MIDWAY THROUGH SURGERY. THIS HAS HAPPENED SIX TIMES. THEY ALREADY GAVE THE SUTURES AWAY TO DEPARTMENTS AND THEY GOT RID OF ALL THE BOXES. THERE WAS NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20752320 ↗
• MalfunctionNov 21, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE KEEPS COMING OFF THE NEEDLE MIDWAY THROUGH SURGERY. THIS HAS HAPPENED SIX TIMES. THEY ALREADY GAVE THE SUTURES AWAY TO DEPARTMENTS AND THEY GOT RID OF ALL THE BOXES. THERE WAS NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20752313 ↗
• MalfunctionNov 21, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE KEEPS COMING OFF THE NEEDLE MIDWAY THROUGH SURGERY. THIS HAS HAPPENED SIX TIMES. THEY ALREADY GAVE THE SUTURES AWAY TO DEPARTMENTS AND THEY GOT RID OF ALL THE BOXES. THERE WAS NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20751763 ↗
• MalfunctionNov 21, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE KEEPS COMING OFF THE NEEDLE MIDWAY THROUGH SURGERY. THIS HAS HAPPENED SIX TIMES. THEY ALREADY GAVE THE SUTURES AWAY TO DEPARTMENTS AND THEY GOT RID OF ALL THE BOXES. THERE WAS NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20751626 ↗
• MalfunctionNov 21, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE KEEPS COMING OFF THE NEEDLE MIDWAY THROUGH SURGERY. THIS HAS HAPPENED SIX TIMES. THEY ALREADY GAVE THE SUTURES AWAY TO DEPARTMENTS AND THEY GOT RID OF ALL THE BOXES. THERE WAS NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20751598 ↗
• MalfunctionNov 21, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE KEEPS COMING OFF THE NEEDLE MIDWAY THROUGH SURGERY. THIS HAS HAPPENED SIX TIMES. THEY ALREADY GAVE THE SUTURES AWAY TO DEPARTMENTS AND THEY GOT RID OF ALL THE BOXES. THERE WAS NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20751591 ↗
• MalfunctionNov 12, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE OPERATION, THE DOCTOR USED SUTURE TO SUTURE THE PATIENT'S FAT LAYER, BUT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND GOT STUCK IN THE FAT LAYER. THE CHIEF SURGEON AND ASSISTANT CAREFULLY SEARCHED FOR THE NEEDLE ONE BY ONE, AND AFTER FINDING IT, THEY CHECKED WITH THE CIRCULATING NURSE TO SEE IF IT WAS INTACT. THEY THEN REPLACED IT WITH ANOTHER SUTURE OF THE SAME BATCH NUMBER AND SUCCESSFULLY COMPLETED THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20667055 ↗
• MalfunctionOct 28, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A LACERATION CLOSURE PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2024 AD SUTURE WAS USED. THE 3-0 SUTURE NEEDLE DISCONNECTED OFF DURING LAST STITCH OF REPAIR. CNM WAS PERFORMING THE LAST STITCH AND WHEN SHE PULLED THROUGH THE NEEDLE WAS GONE. UNKNOWN IF THE DEVICE WAS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20548287 ↗

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