MONOCRYL Y427HRecalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10705031059153), received between May 9, 2018 and Sep 21, 2026 — classified as 9 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Break” (27 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K964072); 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.

Recalls naming this device

1. May 10, 2024Open, Classified

   Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

   Z-2148-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Break

  It was reported that a patient underwent an unknown procedure in (b)(6) 2026 and suture was used. During closing of surgical site, Surgeon and OPERATING ROOM tech informed them, Circulator RN that the tip of a small suture needle 17mm broke off (Monocryl 3-0 PS-2). Surgical Team immediately looked around the operative area and OPERATING ROOM for the tip of needle and did not find it. The tip of the needle is so small (less than 13mm) per policy they do not take x-ray. Since the C-arm that was used in the case was still in the room, Dr had call Radiology Tech and took some magnified C-arm x-rays to see if it is inside the patient's foot/leg. Dr did not see anything on the x-rays. Device is not available for return. There were no patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842611 ↗
• MalfunctionJun 22, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE TIP OF THE NEEDLE BROKE OFF DURING USE. THE STAFF STATED THAT THEY HAVE NOTICED IT OCCURRING MORE FREQUENTLY. NO HARM TO THE PATIENT. IT WAS IMMEDIATELY NOTICED AND SURGEON ASKED FOR A NEW NEEDLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25588325 ↗
• MalfunctionApr 6, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF DURING SUTURING. SEARCH FOR THE NEEDLE THAT FELL, FOUND ON THE GROUND. WIRE CHANGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791220 ↗
• InjuryJan 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT INTERVENTION FOR REDUCTION OF RIGHT BREAST SYMMETRIZATION AND LEFT MASTECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. DURING, FIRST OPERATIVE STAGE ON SYMMETRIZATION, WIRE BREAKAGE OF NEEDLE AT CRIMP POINT OCCURRED. THE NEEDLE IS LOST IN THE MASS, IMPOSSIBLE TO FIND. AS A FIRST INTENTION, USE OF AN ULTRASOUND SCANNER TO TRY TO FIND THE NEEDLE, IN VAIN. SECONDARY USE OF FLUOROSCOPY. THE NEEDLE IS INDEED PRESENT IN THE MASS, BUT LEADS TO PARTIAL DECAY OF THE PRESERVED PART AND THE POSITIONING OF THE PREPARED PILLARS. IN FINE, NEEDLE FOUND AND EXTRACTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 23981117 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN TOTAL HIP PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A DEHISCENCE. NO PATIENT INFECTION WAS NOTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22311099 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT 3 SUTURES BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967888 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT 3 SUTURES BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967843 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT 3 SUTURES BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967811 ↗
• MalfunctionMar 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THE THREAD USED FOR THE DEEP SUTURE BECAME WEAKENED, IT WAS BRITTLE, DID NOT HOLD, AND SPLIT INTO TWO. THE DEEP SUTURE WAS THEREFORE COMPROMISED, AND A CHANGE OF THREAD WAS NECESSARY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21713057 ↗
• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED ON THE SKIN. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE OFF WHEN GRABBED WITH THE NEEDLE DRIVER AS IT WAS PULLED OUT. THE PHYSICIAN WAS UNABLE TO FIND THE TIP. THE LOCATION OF THE NEEDLE TIP WAS UNKNOWN, HOWEVER, THE SURGEON OPINED, THE NEEDLE TIP COULD POSSIBLY BE IN THE PATIENT OR ON THE DRAPES. NO X-RAYS WERE PERFORMED AS THE SURGEON FELT THE PIECE WOULD BE TOO SMALL TO DETECT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19560199 ↗
• MalfunctionMar 22, 2024Delivered as Unsterile Product; Appropriate Device Problem Term/Code Not Available; Delivered as Unsterile Product; Appropriate Device Problem Term/Code Not Available

  BEFORE USE ON THE PATIENT, ON (B)(6) 2024. IT WAS REPORTED THAT THAT GLOBAL BRAND PROTECTION LATAM TEAM HAS PERFORMED A MARKET SURVEY IN VENEZUELA, IN (B)(6), 8 DIFFERENT NON-AUTHORIZED AND SUSPICIOUS SELLERS. ALL PRODUCTS BOUGHT ARE LISTED BELOW. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18963600 ↗
• MalfunctionJun 26, 2023Break; Break

  IT WAS REPORTED, THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2023. AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON USED MONOCRYL 3-0 PS2. AFTER HANDLING BACK, THE SUTURE TO THE SCRUB, THE SCRUB NOTICED THE SHARP END OF THE SUTURE WAS MISSING (FEW MILLIMETERS APPROXIMATELY). THE NURSE MENTIONED, IT TO THE SURGEON AND START SEARCHING .HOPING THEY WILL FIND IT EVEN THOUGH IT SEEMS TO BE IMPOSSIBLE, DUE TO THE SIZE OF IT. THE SCRUB NURSE FOUND IT SHORTLY ON PATIENTS CHEST. THIS SUTURE HAPPENED TO BE THE LAST ITEM FROM THIS BOX/BATCH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199978 ↗
• MalfunctionJun 26, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON USED MONOCRYL 3-0 PS2. AFTER HANDLING BACK, THE SUTURE TO THE SCRUB, THE SCRUB NOTICED THE SHARP END OF THE SUTURE WAS MISSING (FEW MILLIMETERS APPROXIMATELY). THE NURSE MENTIONED IT TO THE SURGEON AND START SEARCHING HOPING THEY WILL FIND IT EVEN THOUGH IT SEEMS TO BE IMPOSSIBLE DUE TO THE SIZE OF IT. THE SCRUB NURSE FOUND IT SHORTLY ON PATIENTS¿ CHEST. THIS SUTURE HAPPENED TO BE THE LAST ITEM FROM THIS BOX/BATCH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199976 ↗
• MalfunctionJul 19, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE CAME OF THE NEEDLE. DURING SURGERY, THE SUTURE SPLIT IN HALF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15059307 ↗
• MalfunctionJul 19, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE CAME OF THE NEEDLE. DURING SURGERY, THE SUTURE SPLIT IN HALF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15059257 ↗
• MalfunctionJul 19, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE CAME OF THE NEEDLE. DURING SURGERY, THE SUTURE SPLIT IN HALF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15059048 ↗
• MalfunctionJul 5, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYN PROCEDURE IN (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE GYN SURGEONS ARE HAVING PROBLEMS WITH THE SUTURE. THE SUTURE IS BREAKING WHEN CLOSING THE SKIN. LOT NUMBER IS NOT AVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14920113 ↗
• MalfunctionMay 30, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE ON FIRST PASS OUT OF PACKAGING, IT SNAPPED ONLY A FEW CM FROM THE NEEDLE. IT WAS A BRAND NEW SUTURE AND IT WAS THE VERY FIRST BITE THROUGH THE PATIENT'S SOFT TISSUE, NOT EVEN SKIN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14545324 ↗
• MalfunctionJan 5, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL VERTICAL MASTOPEXY AND ABDOMINOPLASTY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. HALFWAY THROUGH THE SUTURE IT HAD ALMOST A BARB AND AFTER THE FIRST PASS IT SPLIT LIKE A SPLIT HAIR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13167720 ↗
• MalfunctionJul 31, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR PROCEDURE ON (B)(6)2021 AND SUTURE WAS USED. WHEN TRYING TO USE THE SUTURE, IT BROKE WITHOUT EXERTING TENSION. THE PATIENT HAD NO REPERCUSSIONS; OTHER SUTURES WERE USED TO CONTINUE WITH THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12257033 ↗
• MalfunctionJul 20, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE SUTURE WAS IS NOT ABSORBING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12195990 ↗
• InjuryJul 20, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE SUTURE WAS IS NOT ABSORBING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12195982 ↗
• MalfunctionJul 20, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE SUTURE WAS IS NOT ABSORBING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12195979 ↗
• MalfunctionJul 20, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE SUTURE WAS IS NOT ABSORBING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12195976 ↗
• InjuryJul 20, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE SUTURE WAS IS NOT ABSORBING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12195973 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964072. One submission often covers many models, so check the product and lot details in each record.

• Z-0487-2025 · Oct 8, 2024 · Open, Classified
  MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and