Coated VICRYL VCPB864DRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10705031056664), received between Feb 28, 2018 and Sep 4, 2026 — classified as 1 injury, 29 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50610623 ↗
• MalfunctionMar 6, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, THERE HAD BEEN SPLINTER-LIKE MATTER ATTACHED TO THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532885 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN ORTHOPEDIC SURGERY, WHEN PASSING THE NEEDLE THROUGH THE SKIN HOLDING BY THE NEEDLE HOLDER DURING USE, AROUND SWAGE PART OF THE NEEDLE BROKE. IT IS CONFIRMED THAT NO PIECES WERE LEFT INSIDE THE PATIENT. OTHER 7 NEEDLE-SUTURES COULD BE USED AS USUAL. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293819 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN. THIS EVENT OCCURRED IN SOME PACKS IN THE SAME BOX. THE SALES REP IS CURRENTLY CHECKING THE SPECIFIC NUMBER. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452280 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN. THIS EVENT OCCURRED IN SOME PACKS IN THE SAME BOX. THE SALES REP IS CURRENTLY CHECKING THE SPECIFIC NUMBER. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451896 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN. THIS EVENT OCCURRED IN SOME PACKS IN THE SAME BOX. THE SALES REP IS CURRENTLY CHECKING THE SPECIFIC NUMBER. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451815 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN. THIS EVENT OCCURRED IN SOME PACKS IN THE SAME BOX. THE SALES REP IS CURRENTLY CHECKING THE SPECIFIC NUMBER. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451810 ↗
• MalfunctionAug 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN INTO SMALL PIECES EVEN THOUGH THE PRODUCT HAS NOT BEEN USED YET. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. UPON EVALUATION, SUTURE DEGRADATION WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923286 ↗
• MalfunctionJul 30, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PRIMARY PACKAGE OF THE SUTURE WAS FOUND DAMAGED PRIOR TO USE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663862 ↗
• MalfunctionJun 26, 2025Material Separation; Material Separation

  IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. AFFILIATE REFERENCE NUMBER: (B)(4). PLEASE TAKE PHOTOS FOR JAPANESE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22336626 ↗
• MalfunctionMay 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE PRIMARY PACKAGE OF THE SUTURE WAS FOUND DAMAGED PRIOR TO USE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTO. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047807 ↗
• MalfunctionApr 3, 2025Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN ORTHOPEDIC SURGERY, THE SUTURING WAS NOT SMOOTHLY WHEN DERMIS SUTURING WAS PERFORMED (SINGLE NODULE, AND NOT INSTRUMENT TYING), SO WHEN THE NEEDLE TIP WAS CHECKED, IT WAS NOT SHARP. THERE IS A POSSIBILITY THAT THE NEEDLE TIP HAD BEEN BROKEN. IT WAS CONFIRMED THAT IT WAS NOT IN THE PATIENT'S BODY AFTER SURGERY. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21765599 ↗
• MalfunctionOct 31, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20579733 ↗
• MalfunctionOct 31, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN SEPTEMBER 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20579665 ↗
• MalfunctionApr 23, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHEN THE NURSE PASSED THE NEEDLE TO THE DOCTOR, THE NEEDLE TIP WAS BROKEN EASILY. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19162600 ↗
• MalfunctionJan 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BHA: BIPOLAR HIP ARTHROPLASTY ON (B)(6). 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP WAS BROKEN DURING INTERRUPTED SUTURE ON THE SUBCUTANEOUS. THE SURGEON DISCARDED THE BROKEN NEEDLE TIP. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18501908 ↗
• MalfunctionAug 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAMINOPLASTY ON (B)(6) 2023 AND SUTURE WAS USED ON THE SUBCUTANEOUS TO CLOSE THE WOUND. THE SUTURE METHOD WAS INTERRUPTED SUTURE. DURING THE PROCEDURE, A SCRUB NURSE NOTICED THAT THE NEEDLE TIP WAS BROKEN WHEN THE NURSE WAS COUNTING THE NUMBER OF NEEDLES AFTER WOUND CLOSURE AND REPORTED IT TO THE SURGEON ON THE SPOT. AN X-RAY WAS IMMEDIATELY PERFORMED TO LOOK FOR A NEEDLE TIP THAT MIGHT HAVE BEEN LEFT IN THE BODY, BUT NONE WAS FOUND. THE OPERATION TIME WAS EXTENDED BY 45 MINUTES. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS THE PATIENT IS IN THE HOSPITAL. THE SURGEON¿S OPINION ABOUT THE CAUSAL RELATIONSHIP BETWEEN PRODUCT AND EVENT WAS REPORTED AS NO. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17509555 ↗
• MalfunctionJul 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE BROKE AND THE BROKEN NEEDLE WAS FOUND. AN X-RAY WAS TAKEN AND THERE WAS NO RESIDUAL NEEDLE IN THE BODY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15041041 ↗
• MalfunctionApr 20, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PRODUCT WAS USED ON THE SUBCUTANEOUS DURING INTERRUPTED SUTURING, THE FOLLOWING EVENTS OCCURRED. THREE WEEKS AFTER THE SURGERY, IN THE WARD/ICU, MARKS LIKE WATER SWELLING OCCURRED. IT WAS SIMILAR TO WHEN THE BEARD IS BURIED UNDER THE SKIN. IT OCCURRED ABOUT 3 WEEKS AFTER THE SURGERY AND THE KNOT IS POINTING DOWNWARDS SO IT IS UNLIKELY THAT THE KNOT IS EXPOSED ON THE SURFACE. ADDITIONAL INFORMATION WAS REQUESTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Pocket Erosion; Purulent Discharge; Swelling/ Edema

  MAUDE report 14164381 ↗
• MalfunctionMay 20, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE TIP BROKE. THE SURGEON COMMENTED THAT THE GRIP POSITION MIGHT HAVE BEEN BAD. NO DEVICE LEFT IN THE PATIENT¿S BODY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11856531 ↗
• MalfunctionMar 24, 2021Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SCAPULA FRACTURE SURGERY ON (B)(6) 2021 AND THE SUTURE WAS USED FOR SUBCUTANEOUS SUTURING. WHEN TAKING OUT THE NEEDLE, IT WAS CONFIRMED THAT THE NEEDLE TIP HAD BEEN NOT SHARP IN THE SURGICAL FIELD. CONSIDERING THE POSSIBILITY THAT THE TIP OF THE NEEDLE MIGHT HAVE BROKEN, X-RAY WAS TAKEN, AND IT SHOWED A WHITE SHADOW, BUT IT COULD NOT BE CONFIRMED WHETHER IT WAS THE TIP. IT WAS UNKNOWN WHETHER OR NOT THERE WAS FOREIGN MATTER. ACCORDING TO THE RESULTS OF THE APPEARANCE AFTER LOCAL INSPECTION, THE NEEDLE WAS NOT BROKEN AND WAS UNPOLISHED. NO TREATMENT WAS PERFORMED AS OF NOW. THERE IS NO PROBLEM IN PATIENT CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11565596 ↗
• MalfunctionJan 13, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167970 ↗
• MalfunctionJan 11, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SWAGE PART OF THE NEEDLE WAS BROKEN OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11151289 ↗
• MalfunctionDec 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11057407 ↗
• MalfunctionDec 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11057387 ↗

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