PDS Z451GRecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10705031218697), received between Jun 4, 2018 and Jun 24, 2026 — classified as 46 malfunctions.

The most frequently reported specific device problem is “Break” (39 reports).

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 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2026Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2026 AND SUTURE WAS USED. REPORT A FAULTY SUTURE NEEDLE. NO CONSEQUENCES REPORTED. PRODUCT AVAILABILITY UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25611432 ↗
• MalfunctionMar 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY SALES REP THAT ACCOUNT HAD MULTIPLE INCIDENTS WHERE THE NEEDLES WERE FALLING OFF OF THE MONOCRYL 2-0 AND 4-0 AND PDS THEY ORDERING. THIS HAPPENED WITH VARIOUS LOT NUMBER OVER A PERIOD OF ABOUT A YEAR. THEY WERE UNABLE TO RECORD THE LOT NUMBERS OF THE AFFECTED PRODUCTS AT THE TIME. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE AVAILABILITY IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24703040 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEY HAD A BIT OF A NEAR DISASTER, DR REMOVED A MASS AND WHEN THE DOG WAS SET TO GO HOME THE INCISION ACTUALLY LET GO, WHEN DR WENT IN TO FIND OUT WHAT WAS HAPPENING, DR FOUND THAT THE SUTURE HAD ACTUALLY BEEN IN PIECES, LIKE IT HAD DISINTEGRATED. HE USED MOST OF THE BOX ON PRIOR SURGERIES AND THEY ARE BIT APPREHENSIVE ABOUT THIS HAPPENING AGAIN. THE REASON THIS CONCERNS IS BECAUSE THIS HAPPENED MANY MANY YEARS AGO TO ANOTHER DR, IT WAS A CASSETT, SEVERAL OF THEM, IT LEFT A BAD TASTE IN THEIR MOUTH. IT HAPPENED WHEN THE DOG WAS STILL HERE AND IS DOING VERY WELL AT HOME NOW. DEVICE AVAILABILITY IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316594 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEY HAD A BIT OF A NEAR DISASTER, DR REMOVED A MASS AND WHEN THE DOG WAS SET TO GO HOME THE INCISION ACTUALLY LET GO, WHEN DR WENT IN TO FIND OUT WHAT WAS HAPPENING, DR FOUND THAT THE SUTURE HAD ACTUALLY BEEN IN PIECES, LIKE IT HAD DISINTEGRATED. HE USED MOST OF THE BOX ON PRIOR SURGERIES AND THEY ARE BIT APPREHENSIVE ABOUT THIS HAPPENING AGAIN. THE REASON THIS CONCERNS IS BECAUSE THIS HAPPENED MANY YEARS AGO TO ANOTHER DR, IT WAS A CASSETTE, SEVERAL OF THEM, IT LEFT A BAD TASTE IN THEIR MOUTH. IT HAPPENED WHEN THE DOG WAS STILL HERE AND IS DOING VERY WELL AT HOME NOW. DEVICE AVAILABILITY IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316387 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. POST-OP, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEY HAD A BIT OF A NEAR DISASTER, DR REMOVED A MASS AND WHEN THE DOG WAS SET TO GO HOME THE INCISION ACTUALLY LET GO, WHEN DR WENT IN TO FIND OUT WHAT WAS HAPPENING, DR FOUND THAT THE SUTURE HAD ACTUALLY BEEN IN PIECES, LIKE IT HAD DISINTEGRATED. HE USED MOST OF THE BOX ON PRIOR SURGERIES AND THEY ARE BIT APPREHENSIVE ABOUT THIS HAPPENING AGAIN. THE REASON THIS CONCERNS IS BECAUSE THIS HAPPENED MANY YEARS AGO TO ANOTHER DR, IT WAS A CASSETT, SEVERAL OF THEM, IT LEFT A BAD TASTE IN THEIR MOUTH. IT HAPPENED WHEN THE DOG WAS STILL HERE AND IS DOING VERY WELL AT HOME NOW. DEVICE AVAILABILITY IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316375 ↗
• MalfunctionApr 22, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. POST-OP ON (B)(6) 2025, IT WAS REPORTED BY DISTRIBUTOR THAT PER CLINIC TWO CAT SPAYS THEY DID THE WEEK OF (B)(6) HAD THEIR ABDOMINAL CONTENTS HERNIATE OUT OF THE ABDOMEN. THE SURGERY WAS DONE BY A DECADES LONG EXPERIENCED VET WHO DOES SURGERY ALL THE TIME. THEY USED THIS SUTURE TO TIE OFF THE OVARIES AND CLOSE THE ABDOMINAL WALL. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia; Wound Dehiscence

  MAUDE report 21882293 ↗
• MalfunctionApr 22, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. POST-OP ON (B)(6) 2025, IT WAS REPORTED BY DISTRIBUTOR THAT PER CLINIC TWO CAT SPAYS THEY DID THE WEEK OF (B)(6) HAD THEIR ABDOMINAL CONTENTS HERNIATE OUT OF THE ABDOMEN. THE SURGERY WAS DONE BY A DECADES LONG EXPERIENCED VET WHO DOES SURGERY ALL THE TIME. THEY USED THIS SUTURE TO TIE OFF THE OVARIES AND CLOSE THE ABDOMINAL WALL. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia; Wound Dehiscence

  MAUDE report 21882273 ↗
• MalfunctionApr 22, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. POST-OP ON (B)(6) 2025, IT WAS REPORTED BY DISTRIBUTOR THAT PER CLINIC TWO CAT SPAYS THEY DID THE WEEK ON (B)(6) HAD THEIR ABDOMINAL CONTENTS HERNIATE OUT OF THE ABDOMEN. THE SURGERY WAS DONE BY A DECADES LONG EXPERIENCED VET WHO DOES SURGERY ALL THE TIME. THEY USED THIS SUTURE TO TIE OFF THE OVARIES AND CLOSE THE ABDOMINAL WALL. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia; Wound Dehiscence

  MAUDE report 21882272 ↗
• MalfunctionMar 26, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. POST-OP ON (B)(6) 2025, IT WAS REPORTED BY DISTRIBUTOR THAT PER CLINIC TWO CAT SPAYS THEY DID THE WEEK OF (B)(6) HAD THEIR ABDOMINAL CONTENTS HERNIATE OUT OF THE ABDOMEN. THE SURGERY WAS DONE BY A DECADES LONG EXPERIENCED VET WHO DOES SURGERY ALL THE TIME. THEY USED THIS SUTURE TO TIE OFF THE OVARIES AND CLOSE THE ABDOMINAL WALL. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia; Wound Dehiscence

  MAUDE report 21699183 ↗
• MalfunctionMar 26, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. POST-OP ON (B)(6) 2025, IT WAS REPORTED BY DISTRIBUTOR THAT PER CLINIC TWO CAT SPAYS THEY DID THE WEEK OF (B)(6) HAD THEIR ABDOMINAL CONTENTS HERNIATE OUT OF THE ABDOMEN. THE SURGERY WAS DONE BY A DECADES LONG EXPERIENCED VET WHO DOES SURGERY ALL THE TIME. THEY USED THIS SUTURE TO TIE OFF THE OVARIES AND CLOSE THE ABDOMINAL WALL. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia

  MAUDE report 21699172 ↗
• MalfunctionSep 3, 2024Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER CUSTOMER: "CLINIC PURCHASED A BOX OF SUTURE SUT PDS II 2-0 FS-1 27". THE FIRST TWO PACKS OF SUTURE BROKE IN THE MIDDLE WHEN TRYING TO USE THEM. THE SUTURE WAS OPENED WHILE PERFORMING A SPAY PROCEDURE. WHEN BEGINNING TO USE IT ON A PATIENT, IT BROKE. THE DOCTOR OPENED A NEW SUTURE PACK, ATTEMPTED TO USE IT AND IT BROKE. THEY CHOSE A DIFFERENT SUTURE FOR COMPLETING THE PROCEDURE. THE CLINIC WANTS TO RETURN THE TEN REMAINING PACKS. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20126626 ↗
• MalfunctionSep 3, 2024Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER CUSTOMER: "CLINIC PURCHASED A BOX OF SUTURE SUT PDS II 2-0 FS-1 27". THE FIRST TWO PACKS OF SUTURE BROKE IN THE MIDDLE WHEN TRYING TO USE THEM. THE SUTURE WAS OPENED WHILE PERFORMING A SPAY PROCEDURE. WHEN BEGINNING TO USE IT ON A PATIENT, IT BROKE. THE DOCTOR OPENED A NEW SUTURE PACK, ATTEMPTED TO USE IT AND IT BROKE. THEY CHOSE A DIFFERENT SUTURE FOR COMPLETING THE PROCEDURE. THE CLINIC WANTS TO RETURN THE TEN REMAINING PACKS.THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20126617 ↗
• MalfunctionAug 14, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT MASS REMOVAL PROCEDURE IN 2024 AND SUTURE WAS USED. DURING MASS REMOVAL, THE INCISION GOT INFECTED AND CAME APART. THE SUTURE WAS HANGING OUT, KNOTS WERE NOT INTACT AT SITE OF DEHISCENCE. SKIN WAS INFECTED, INFLAMED WITH DISCHARGE AT THIS LOCATION. THE SUTURE PULLED OUT OF THE TISSUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 19981680 ↗
• MalfunctionApr 2, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ANIMAL SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. WHEN THE DOCTOR WAS USING THE SUTURE, IT WAS TEARING IN THE MIDDLE AND LOOKED LIKE IT WAS SHREDDING. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THIS HAPPENED TWICE DURING THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19028151 ↗
• MalfunctionApr 2, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ANIMAL SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. WHEN THE DOCTOR WAS USING THE SUTURE, IT WAS TEARING IN THE MIDDLE AND LOOKED LIKE IT WAS SHREDDING. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THIS HAPPENED TWICE DURING THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19026491 ↗
• MalfunctionApr 20, 2023Break; Break

  THE SUTURE KEEPS BREAKING WHEN THE SURGEON TRIES TO TIE A KNOT PATIENT STATUS/ OUTCOME / CONSEQUENCES --> , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, INCIDENT 3/4 RELATED TO (B)(4) REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16782030 ↗
• MalfunctionApr 20, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE SUTURE KEEPS BREAKING WHEN THE SURGEON TRIES TO TIE A KNOT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16782029 ↗
• MalfunctionApr 20, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE SUTURE KEEPS BREAKING WHEN THE SURGEON TRIES TO TIE A KNOT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781994 ↗
• MalfunctionApr 10, 2023Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWED PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE SUTURE KEEPS BREAKING WHEN THE SURGEON TRIES TO TIE A KNOT, NO ADVERSE CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16710218 ↗
• MalfunctionFeb 10, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAYING PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE IN HALF. ANOTHER DEVICE WITH SAME LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16355590 ↗
• MalfunctionOct 25, 2022Break; Break

  IT WAS REPORTED BY AN ATTORNEY THAT AN ANIMAL UNDERWENT AN OVARIOHYSTERECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE SUTURE BROKE. IT WAS REPORTED THAT THE KNOTS HELD AND THAT IT APPEARED THE SUTURE BROKE SOMEWHERE IN THE MIDDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666256 ↗
• MalfunctionOct 25, 2022Break; Break

  IT WAS REPORTED BY AN ATTORNEY THAT AN ANIMAL UNDERWENT AN OVARIOHYSTERECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE SUTURE BROKE. IT WAS REPORTED THAT THE KNOTS HELD AND THAT IT APPEARED THE SUTURE BROKE SOMEWHERE IN THE MIDDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666223 ↗
• MalfunctionJul 7, 2022Break; Break

  IT WAS REPORTED THAT A ANIMAL UNDERWENT A CYSTOTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. AFTER FULLY HEALED THE K-9 GNAWED AT THE LOCATION OF THE INCISION CAUSING TISSUE DAMAGE ON (B)(6) 2022. K-9 WAS TREATED WITH A TOPICAL ANTIBIOTIC. ON (B)(6) 2022 AREA ON K-9 HAS GOTTEN LARGER AND IS RED. CONE HAD BEEN REMOVED ALLOWING THE K-9 TO LICK AT THE AREA. OWNER WAS ADVISED TO REPLACE THE CONE AND MONITOR FURTHER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 14947220 ↗
• MalfunctionJul 7, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. AFTER FULLY HEALED THE K-9 GNAWED AT THE LOCATION OF THE INCISION CAUSING TISSUE DAMAGE ON (B)(6) 2022. OWNER WAS INSTRUCTED TO WASH WITH LIGHT SOAP AND REPLACE THE CONE AND MONITOR FURTHER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 14947015 ↗
• MalfunctionJul 7, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A ORCHIDECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. AFTER FULLY HEALED THE K-9 GNAWED AT THE LOCATION OF THE INCISION CAUSING TISSUE DAMAGE ONCE THE CONE WAS REMOVED ON (B)(6) 2022. K-9 STARTED OPENING THE INCISION ON (B)(6) 2022 SO THE CONE WAS REPLACED. K-9 WAS SEEN IN OFFICE ON (B)(6) 2022 WHERE THE INCISION WAS SPRAYED WITH AN ANTIBIOTIC ONCE A DAY. THE SCAB WAS STARTING TO FALL OFF ON (B)(6) 2022 AND UNDER APPEARED TO BE A RED HEMATOMA. ON (B)(6) 2022 APPEARS TO HAVE A KELOID HEALING ON IT WITH THE AREA STILL RED AND RAW WITH A HOLE SUBCUTANEOUSLY. PICTURES AVAILABLE. K-9 RETURNED TO OFFICE ON (B)(6) 2022 AND WAS SENT HOME WITH CESASEPTIN ORAL ANTIBIOTIC. K-9 HAS CONTINUED TO WEAR HIS CONE THROUGH THIS TIME. THERE WERE NO CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hematoma; Impaired Healing; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 14946886 ↗