Coated VICRYL VCP959HRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031056237), received between Feb 6, 2019 and Jun 1, 2023 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2023Break; Break

  IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT SUTURE DEGRADATION WAS OBSERVED, THE STRAND HAS BEGUN WITH A DEGRADATION PROCESS CAUSED BY EXPOSURE TO THE ENVIRONMENT. IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE A SUTURE WAS USED. DURING REMOVAL FROM PACKAGE, THE SUTURE BROKE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17043456 ↗
• MalfunctionJun 1, 2023Break; Break

  IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT SUTURE DEGRADATION WAS OBSERVED, THE STRAND HAS BEGUN WITH A DEGRADATION PROCESS CAUSED BY EXPOSURE TO THE ENVIRONMENT. IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE A SUTURE WAS USED. DURING REMOVAL FROM PACKAGE, THE SUTURE BROKE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17043444 ↗
• InjuryMar 19, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROUTINE C-SECTION ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED TO CLOSE THE FASCIAL LAYER OF THE ABDOMINAL WALL. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS HOSPITALIZED POST-OP. A DAY AFTER THE SURGERY, WHILE THE PATIENT WAS IN HOSPITALIZATION, A GAP WAS NOTICED IN THE WOUND AND PARTS OF INTESTINE WERE VISIBLE. THE PATIENT UNDERWENT AN EMERGENCY SURGERY WHEN IT WAS FOUND THAT BOTH KNOTS WERE SECURED BUT THE SUTURE WAS TORN IN THE MIDDLE DUE TO HIGH PRESSURE. THE PATIENT WAS OPERATED ON AND CLOSED. THE SURGEON HAS MENTIONED THAT THE TECHNIQUE WAS NORMAL AND IT IS UNCLEAR WHY THE SUTURE WAS TORN AND THE FASCIA OPENED. THE HEAD SURGEON OPINE THAT ACCORDING TO THE PROBLEM IS PROBABLY NOT IN THE SUTURE ITSELF AND THIS IS A RARE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 11529777 ↗
• InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT GOT INFECTED WITH AN OPENING OF THE STERNUM SECTION. PER CUSTOM ROUTINE, THE STERNUM WAS CLOSED IN TWO STAGES: THE SUBCUTANEOUS LAYER WAS SEWN WITH ONE SUTURE THREAD AND THE SKIN WAS CLOSED WITH SKIN STAPLER. AFTER THE SURGERY, THE PATIENT RETURNED WHEN THE INCISION WAS REDDENED AND IT WAS OBSERVED THAT THE THREADS WERE EMITTED FROM THE INCISION. THE PATIENT HAD TO UNDERGO SEVERAL TREATMENTS UNTIL THE INFECTION PASSED. THE PATIENT HAD ANTIBIOTIC TREATMENT AND RESUTURE OF THE WOUND. TODAY THE CONDITION OF THE PATIENT IS WELL AND BACK TO NORMAL. THE SURGEON COULDN¿T POINT THE CAUSE OF THE INFECTION: WHETHER THE INFECTION AND OPENING OF THE INCISION ARE THE RESULT OF A PROBLEM WITH THE SUTURE OR BECAUSE OF AN UNKNOWN CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body Reaction; No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 8595755 ↗
• InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT GOT INFECTED WITH AN OPENING OF THE STERNUM SECTION. PER CUSTOM ROUTINE, THE STERNUM WAS CLOSED IN TWO STAGES: THE SUBCUTANEOUS LAYER WAS SEWN WITH ONE SUTURE THREAD AND THE SKIN WAS CLOSED WITH SKIN STAPLER. AFTER THE SURGERY, THE PATIENT RETURNED WHEN THE INCISION WAS REDDENED AND IT WAS OBSERVED THAT THE THREADS WERE EMITTED FROM THE INCISION. THE PATIENT HAD TO UNDERGO SEVERAL TREATMENTS UNTIL THE INFECTION PASSED. THE PATIENT HAD ANTIBIOTIC TREATMENT AND RESUTURE OF THE WOUND. TODAY THE CONDITION OF THE PATIENT IS WELL AND BACK TO NORMAL. THE SURGEON COULDN¿T POINT THE CAUSE OF THE INFECTION: WHETHER THE INFECTION AND OPENING OF THE INCISION ARE THE RESULT OF A PROBLEM WITH THE SUTURE OR BECAUSE OF AN UNKNOWN CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body Reaction; No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 8595718 ↗
• InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT GOT INFECTED WITH AN OPENING OF THE STERNUM SECTION. PER CUSTOM ROUTINE, THE STERNUM WAS CLOSED IN TWO STAGES: THE SUBCUTANEOUS LAYER WAS SEWN WITH ONE SUTURE THREAD AND THE SKIN WAS CLOSED WITH SKIN STAPLER. AFTER THE SURGERY, THE PATIENT RETURNED WHEN THE INCISION WAS REDDENED AND IT WAS OBSERVED THAT THE THREADS WERE EMITTED FROM THE INCISION. THE PATIENT HAD TO UNDERGO SEVERAL TREATMENTS UNTIL THE INFECTION PASSED. THE PATIENT HAD ANTIOBIOTICAL TREATMENT AND RESUTURE OF THE WOUND. TODAY THE CONDITION OF THE PATIENT IS WELL AND BACK TO NORMAL. THE SURGEON COULDN¿T POINT THE CAUSE OF THE INFECTION: WHETHER THE INFECTION AND OPENING OF THE INCISION ARE THE RESULT OF A PROBLEM WITH THE SUTURE OR BECAUSE OF AN UNKNOWN CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body Reaction; No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 8595660 ↗
• InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT GOT INFECTED WITH AN OPENING OF THE STERNUM SECTION. PER CUSTOM ROUTINE, THE STERNUM WAS CLOSED IN TWO STAGES: THE SUBCUTANEOUS LAYER WAS SEWN WITH ONE SUTURE THREAD AND THE SKIN WAS CLOSED WITH SKIN STAPLER. AFTER THE SURGERY, THE PATIENT RETURNED WHEN THE INCISION WAS REDDENED AND IT WAS OBSERVED THAT THE THREADS WERE EMITTED FROM THE INCISION. THE PATIENT HAD TO UNDERGO SEVERAL TREATMENTS UNTIL THE INFECTION PASSED. THE PATIENT HAD ANTIBIOTIC TREATMENT AND RESUTURE OF THE WOUND. TODAY THE CONDITION OF THE PATIENT IS WELL AND BACK TO NORMAL. THE SURGEON COULDN'T POINT THE CAUSE OF THE INFECTION: WHETHER THE INFECTION AND OPENING OF THE INCISION ARE THE RESULT OF A PROBLEM WITH THE SUTURE OR BECAUSE OF AN UNKNOWN CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body Reaction; No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 8595643 ↗
• InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT GOT INFECTED WITH AN OPENING OF THE STERNUM SECTION. PER CUSTOM ROUTINE, THE STERNUM WAS CLOSED IN TWO STAGES: THE SUBCUTANEOUS LAYER WAS SEWN WITH ONE SUTURE THREAD AND THE SKIN WAS CLOSED WITH SKIN STAPLER. AFTER THE SURGERY, THE PATIENT RETURNED WHEN THE INCISION WAS REDDENED AND IT WAS OBSERVED THAT THE THREADS WERE EMITTED FROM THE INCISION. THE PATIENT HAD TO UNDERGO SEVERAL TREATMENTS UNTIL THE INFECTION PASSED. THE PATIENT HAD ANTIBIOTIC TREATMENT AND RESUTURE OF THE WOUND. TODAY THE CONDITION OF THE PATIENT IS WELL AND BACK TO NORMAL. THE SURGEON COULDN¿T POINT THE CAUSE OF THE INFECTION: WHETHER THE INFECTION AND OPENING OF THE INCISION ARE THE RESULT OF A PROBLEM WITH THE SUTURE OR BECAUSE OF AN UNKNOWN CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body Reaction; No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 8595625 ↗
• InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT GOT INFECTED WITH AN OPENING OF THE STERNUM SECTION. PER CUSTOM ROUTINE, THE STERNUM WAS CLOSED IN TWO STAGES: THE SUBCUTANEOUS LAYER WAS SEWN WITH ONE SUTURE THREAD AND THE SKIN WAS CLOSED WITH SKIN STAPLER. AFTER THE SURGERY, THE PATIENT RETURNED WHEN THE INCISION WAS REDDENED AND IT WAS OBSERVED THAT THE THREADS WERE EMITTED FROM THE INCISION. THE PATIENT HAD TO UNDERGO SEVERAL TREATMENTS UNTIL THE INFECTION PASSED. THE PATIENT HAD ANTIBIOTIC TREATMENT AND RESUTURE OF THE WOUND. TODAY THE CONDITION OF THE PATIENT IS WELL AND BACK TO NORMAL. THE SURGEON COULDN¿T POINT THE CAUSE OF THE INFECTION: WHETHER THE INFECTION AND OPENING OF THE INCISION ARE THE RESULT OF A PROBLEM WITH THE SUTURE OR BECAUSE OF AN UNKNOWN CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body Reaction; No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 8595306 ↗
• InjuryMay 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT GOT INFECTED WITH AN OPENING OF THE STERNUM SECTION. PER CUSTOM ROUTINE, THE STERNUM WAS CLOSED IN TWO STAGES: THE SUBCUTANEOUS LAYER WAS SEWN WITH ONE SUTURE THREAD AND THE SKIN WAS CLOSED WITH SKIN STAPLER. AFTER THE SURGERY, THE PATIENT RETURNED WHEN THE INCISION WAS REDDENED AND IT WAS OBSERVED THAT THE THREADS WERE EMITTED FROM THE INCISION. THE PATIENT HAD TO UNDERGO SEVERAL TREATMENTS UNTIL THE INFECTION PASSED. THE PATIENT HAD ANTIBIOTIC TREATMENT AND RESUTURE OF THE WOUND. TODAY THE CONDITION OF THE PATIENT IS WELL AND BACK TO NORMAL. THE SURGEON COULDN¿T POINT THE CAUSE OF THE INFECTION: WHETHER THE INFECTION AND OPENING OF THE INCISION ARE THE RESULT OF A PROBLEM WITH THE SUTURE OR BECAUSE OF AN UNKNOWN CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body Reaction; No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 8593024 ↗
• InjuryMar 6, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION (FIRST BIRTH) ON (B)(6) 2019 AND SUTURE WAS USED ON THE FASCIA. THE PROCEDURE WAS NORMAL. ON (B)(6) 2019, THE PATIENT FELT AND HEARD SOMETHING SNAP WHILE TRYING TO GET UP FROM HER BED. THE PATIENT IMMEDIATELY COMPLAINED ABOUT A STRANGE FEELING AT THE SURGERY SITE. THE PATIENT WAS RE-EXAMINED (A VISUAL INSPECTION), AND AN EVENTRATION OF THE FASCIA LAYER WAS FOUND, WITH THE BOWELS POPPING OUT. THE PATIENT UNDERWENT A RE-LAPAROTOMY TO CLOSE THE FASCIA. ACCORDING TO THE SURGEON, THE SUTURE WAS TORN AT THE PATIENT'S LEFT SIDE OF THE FASCIA, ABOUT 1-2 CM FROM THE CUT'S END AND THE KNOT. THE KNOT ITSELF WAS INTACT. THE RE-LAPAROTOMY WENT NORMAL, AND THE FASCIA WAS RE-SUTURED USING A DIFFERENT SUTURE. THE PATIENT'S CONDITION WAS REPORTED AS DOING WELL. THE SURGEON OPINED THAT THERE WAS NO SPECIAL CONTRIBUTING FACTOR TO THE EVENT AND STATED THE PATIENT IS HEALTHY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 8396156 ↗
• InjuryFeb 6, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS USED ON THE FASCIA WITH A CONTINUOUS SUTURING TECHNIQUE. THE PATIENT EXPERIENCED PAIN ON (B)(6) 2019 AND EXAMINATION SHOWED A FULL EVENTRATION OF THE FASCIA LAYER WITH BOWELS POPPING OUT. A RE-LAPAROTOMY WAS PERFORMED ON (B)(6) 2019 AND THE SURGEON NOTED THAT THE SUTURE WAS TORN IN THE MIDDLE, WHILE THE KNOTS WERE INTACT. THE FASCIA WAS RE-SUTURED WITH A DIFFERENT SUTURE WITH A MIDDLE KNOT. IT WAS REPORTED THAT THE PATIENT DID NOT COUGH DURING THE POST-SECTION RECOVERY. THE PATIENT¿S CONDITION IS REPORTED AS WELL AND DISCHARGED (B)(6) 2019. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Pain; Wound Dehiscence

  MAUDE report 8312728 ↗

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