Coated VICRYL VCP774DRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705031055513), received between Nov 5, 2019 and Jun 17, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Break; Dull, Blunt

  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 AND THE NEEDLE COULD NOT BE PASSED THROUGH DURING LIGATION. SEVERAL PACKS WERE OPENED, BUT THE PROBLEM CONTINUED, AND A TOTAL OF FIVE PACKS FROM THE SAME LOT HAVE DISCARDED INCLUDING THE OPENED ONES. THE PRODUCT WAS USED ON THE SUBCUTANEOUS AND DERMIS. 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 25536778 ↗
• MalfunctionJun 17, 2026Break; Dull, Blunt

  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 AND THE NEEDLE COULD NOT BE PASSED THROUGH DURING LIGATION. SEVERAL PACKS WERE OPENED, BUT THE PROBLEM CONTINUED, AND A TOTAL OF FIVE PACKS FROM THE SAME LOT HAVE DISCARDED INCLUDING THE OPENED ONES. THE PRODUCT WAS USED ON THE SUBCUTANEOUS AND DERMIS. 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 25536769 ↗
• MalfunctionJun 17, 2026Break; Dull, Blunt

  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 AND THE NEEDLE COULD NOT BE PASSED THROUGH DURING LIGATION. SEVERAL PACKS WERE OPENED, BUT THE PROBLEM CONTINUED, AND A TOTAL OF FIVE PACKS FROM THE SAME LOT HAVE DISCARDED INCLUDING THE OPENED ONES. THE PRODUCT WAS USED ON THE SUBCUTANEOUS AND DERMIS. 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 25536761 ↗
• MalfunctionJun 17, 2026Break; Dull, Blunt

  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 AND THE NEEDLE COULD NOT BE PASSED THROUGH DURING LIGATION. SEVERAL PACKS WERE OPENED, BUT THE PROBLEM CONTINUED, AND A TOTAL OF FIVE PACKS FROM THE SAME LOT HAVE DISCARDED INCLUDING THE OPENED ONES. THE PRODUCT WAS USED ON THE SUBCUTANEOUS AND DERMIS. 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 25536747 ↗
• MalfunctionMar 17, 2026Material Separation; Component Missing

  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, IT WAS FOUND THAT THERE HAD BEEN ONE SUTURE WITH ONLY NEEDLE, THE SUTURE HAD NOT BEEN ATTACHED. 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 24618396 ↗
• InjuryJan 23, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SHUNT CASE IN NEUROSURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE TIP WAS BROKEN WHILE SUTURING THE ABDOMEN. THE NEEDLE TIP WAS RETRIEVED IN AN OPEN PROCEDURE AFTER THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24160084 ↗
• MalfunctionDec 23, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEUROSURGERY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN NEUROSURGERY, IT WAS FOUND DURING SUTURING THAT THE NEEDLE TIP HAD BEEN CHIPPED. IT WAS A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881799 ↗
• MalfunctionSep 19, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, A FOREIGN MATTER WAS FOUND. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20260186 ↗
• MalfunctionFeb 20, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE CHIEF SURGEON FOUND A MISSING NEEDLE TIP WITH A LENGTH OF ABOUT 3MM WHILE SUTURING THE SUBCUTANEOUS LAYER. THE SEARCH WAS UNSUCCESSFUL, AND THE TOURING NURSE IMMEDIATELY REPORTED TO THE HEAD NURSE. THE SEARCH FOR THE AREA AROUND THE INCISION, SURGICAL FIELD, AND OPERATING TABLE WAS UNSUCCESSFUL. THE RADIOLOGY DEPARTMENT WAS NOTIFIED TO TAKE A LATERAL LYING POSITION X-RAY IN THE OPERATING ROOM. AFTER READING THE X-RAY, IT WAS CONFIRMED THAT THERE WERE NO FOREIGN OBJECTS LEFT. THE CHIEF SURGEON REPORTED TO ATTENDING AND DECIDED TO ABANDON THE SEARCH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18744782 ↗
• MalfunctionOct 30, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE PATIENT EXPERIENCED INTRAOPERATIVE TISSUE BLEEDING AND THE DOCTOR USED SUTURE TO STOP THE BLEEDING. IT WAS FOUND THAT THE NEEDLE TIP WAS BROKEN WHEN RETRACTED AFTER USE. DOCTOR SEARCH, RINSE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18031857 ↗
• MalfunctionOct 6, 2023Material Deformation; Material Deformation

  IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT NEEDLE BREAKAGE WAS OBSERVED, A FRACTURE WAS OBSERVED AT THE SUTURE ATTACHMENT OF THE NEEDLE. IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE WAS DISTORTED BEFORE USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17885782 ↗
• MalfunctionJul 10, 2023Material Frayed; Defective Component; Material Frayed; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SLIPPAGE WAS POOR AND THE SURFACE OF THE SUTURE WAS ROUGH. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17292574 ↗
• MalfunctionAug 31, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REMOVAL OF INTRACEREBRAL HEMATOMA ON (B)(6) 2022 AND SUTURE WAS USED. DURING USE ON THE PATIENT THE NURSE CHECKED THAT THE OUTER PACKAGE WAS COMPLETE, AND THEN PUT IT ON THE OPERATING TABLE. THE NURSE CLAMPED THE NEEDLE AND HANDED IT TO THE OPERATING DOCTOR. AFTER THE DOCTOR SEWED SEVERAL NEEDLES, THE LAST NEEDLE OF THE MENINGEAL TISSUE WAS SUDDENLY BROKEN. AFTER CAREFUL SEARCHING ON AND OFF THE STAGE, THE BROKEN PART WAS FINALLY FOUND AND COULD BE CONSISTENT WITH THE REST. THE SURGERY TIME WAS PROLONGED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15326056 ↗
• MalfunctionJul 14, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. AFTER OPENING THE PACKAGE, A SCRUB NURSE FOUND THAT THERE WAS A NEEDLE WHICH DID NOT HAVE A SUTURE IN THE PACKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15019689 ↗
• MalfunctionDec 28, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN THE SUTURE WAS USED ON THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13094536 ↗
• MalfunctionJul 13, 2021Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ESOPHAGOGASTRECTOMY ON UNKNOWN DATE AND THE SUTURE WAS USED FOR GASTROINTESTINAL ANASTOMOSIS. DURING THE SURGERY, IT WAS FOUND THAT THE SURFACE OF THE SUTURE HAD BEEN FRAYED. ALSO, WHEN THE SUTURE WAS PASSING THROUGH THE INTESTINAL TRACT, IT CAME OUT OF THE NEEDLE HOLE MEANS THAT GASTROINTESTINAL FLUID LEAKED OUT. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO POST-OPERATIVE EFFECT ON THE PATIENT. IN ADDITION, A SURGEON COMMENTED THAT IT WAS POOR FLEXIBILITY; HE FELT THAT THE SUTURE WAS FIRMER THAN USUAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12164362 ↗
• MalfunctionNov 5, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ARTIFICIAL ELBOW JOINT REPLACEMENT SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING INTERRUPTED SUTURING ON THE SUBCUTIS, AFTER PASSING THE NEEDLE THROUGH THE TISSUE, THE SUTURE WAS BROKEN EASILY WHEN PULLING THE SUTURE. THE SURGEON OPINED THAT STRENGTH OF SUTURES WITH THE LOT # WAS WEAK, ANOTHER PACKAGE WAS USED FOR THE PATIENT WITH NO PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9281510 ↗
• MalfunctionNov 5, 2019Break; Tear, Rip or Hole in Device Packaging; Break; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ARTIFICIAL ELBOW JOINT REPLACEMENT SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING INTERRUPTED SUTURING ON THE SUBCUTIS, AFTER PASSING THE NEEDLE THROUGH THE TISSUE, THE SUTURE WAS BROKEN EASILY WHEN PULLING THE SUTURE. THE SURGEON OPINED THAT STRENGTH OF SUTURES WITH THE LOT # WAS WEAK, ANOTHER PACKAGE WAS USED FOR THE PATIENT WITH NO PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9281479 ↗

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