PDS Z398HRecalls & reported problems
Ethicon, LLC · Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture · Class 2 · Implant
All models of PDS (224)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon PDS Z398H is a violet absorbable surgical suture made of polydioxanone, used to close incisions in surgery. The 28 reports, all involving animals rather than people, mostly describe the suture breaking during surgery or coming apart into pieces, with some operations reopening afterwards and a few abscesses at the incision site. There are no deaths and no injuries. No recalls name this device, and reports fell from 4 in the prior 12 months to none since.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10705031060845), received between Feb 27, 2019 and Sep 23, 2025 — classified as 28 malfunctions.
The most frequently reported specific device problem is “Break” (20 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break20
- Material Separation10
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Hernia6
- No Consequences Or Impact To Patient6
- Wound Dehiscence4
- Abscess1
- Purulent Discharge1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2025Material Separation; Material Separation
IT WAS REPORTED AN ANIMAL UNDERWENT A HYSTERECTOMY VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT, DURING THE PROCEDURE THE SUTURE WAS DETACHED TO THE NEEDLE. ABLE TO RETRIEVE. THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23124118 ↗MalfunctionMay 15, 2025Break; Break
IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT SUTURE KEEPS BREAKING DURING SURGERY PER DOCTOR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22026919 ↗MalfunctionMay 15, 2025Break; Break
IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT SUTURE KEEPS BREAKING DURING SURGERY PER DOCTOR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22026913 ↗MalfunctionDec 6, 2024Break; Break
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ENTEROTOMY AND GASTROTOMY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. 3-0 SUTURE WAS USED IN A S.I. PATTERN ENTEROTOMY AND 3-0 SUTURE WAS USED IN SC PATTERN GASTROTOMY WITH CUSHING OVERLAY. SUBCUTICULAR CLOSURE WITH 4-0 SUTURE (SQ WAS 3-0 PDS) RIDDLE. FIVE DAYS POST-OP, INCISION DEHISCED. FOUND THAT THE ENTEROTOMY SITE HAD ALSO DEHISCED. ELECTED HUMANE EUTHANASIA W/O WAKING PET FROM ANESTHESIA. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Wound Dehiscence
MAUDE report 20867572 ↗MalfunctionOct 4, 2024Break; Break
IT WAS REPORTED THAT A CANINE UNDERWENT SURGERY ON (B)(6) 2024 TO REMOVE A MASS AND SUTURE WAS USED. POST-OP, THE SUTURE DEHISCED AND THE SUTURE BROKE. THE CANINE UNDERWENT REVISION SURGERY ON (B)(6) 2024. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Wound Dehiscence
MAUDE report 20369174 ↗MalfunctionOct 4, 2024Break; Break
IT WAS REPORTED THAT A CANINE UNDERWENT SURGERY ON (B)(6) 2024 TO REMOVE THREE MASSES AND SUTURE WAS USED. POST-OP, THE SUTURE DEHISCED AND THE SUTURE BROKE. THE CANINE UNDERWENT REVISION SURGERY ON (B)(6) 2024. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Wound Dehiscence
MAUDE report 20369173 ↗MalfunctionOct 4, 2024Break; Break
IT WAS REPORTED THAT A CANINE UNDERWENT SURGERY ON (B)(6) 2024 TO REMOVE TWO MASSES AND SUTURE WAS USED. POST-OP, THE SUTURE DEHISCED AND THE SUTURE BROKE. THE CANINE UNDERWENT REVISION SURGERY ON (B)(6) 2024. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Wound Dehiscence
MAUDE report 20369159 ↗MalfunctionSep 27, 2024Break; Break
IT WAS REPORTED AN ANIMAL UNDERWENT A MASS REMOVAL VETERINARY PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. POST-OP, IT WAS REPORTED BY A CUSTOMER FROM PISMO BEACH VETERINARY CLINIC, THAT A PATIENT (DOG) HAD A REACTION TO THE SUTURE. THEY DID A MASS REMOVAL IN (B)(6) 2024, AND USED THE SUTURE FOR THAT. THEY SAID THAT ABSCESS APPEARED AT SURGICAL SITE, THEY CULTURED IT AND USED ANTIBIOTICS. THEY HAD TO DO ANOTHER SURGERY TO REMOVE THE TISSUE AROUND THE SUTURE, AND THERE WAS STILL SUTURE IN THERE ALONG WITH PUSS LIKE SUBSTANCE. ON (B)(6) 2024 ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT TISSUE WAS THICKENED AND FIBROUS WITH MULTIPLE DRAINING AREAS, AND MULITPLE SMALL PIECES OF CLEAR SUTURE THAT LOOKED LIKE FISHING LINE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Abscess; Purulent Discharge
MAUDE report 20318012 ↗MalfunctionApr 8, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A VETERINARY SPAY/NEUTER PROCEDURE WAS PERFORMED ON (B)(6) 2024 AND SUTURE WAS USED. WHILE CLOSING, THE NEEDLE CAME RIGHT OFF INTO THE DOG. THE NEEDLE WAS FOUND. NO PATIENT HARM WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19059796 ↗MalfunctionApr 8, 2024Material Separation; Material Separation
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ANIMAL SURGERY ON AN UNKNOWN DATE IN (B)(6) OR (B)(6) OF 2023 AND SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE CAME OFF, BUT THE VET WAS ABLE TO FEEL IT AND THAT NEEDLE DID NOT FALL. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19059738 ↗MalfunctionMay 11, 2023Break; Break
IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CASTRATION ON A CRYPTORCHID FOR THE NEUTERING PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THREE DAYS POST-OP DURING THE EXAMINATION, UPON RE-OPERATION IT WAS SEEN THAT THE SUTURE HAD BROKEN IN 2 DIFFERENT PLACES BUT THE DOCTOR'S KNOTS WERE STILL THERE AND INTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Hernia
MAUDE report 16915680 ↗MalfunctionApr 27, 2023Break; Break
IT WAS REPORTED BY THE CUSTOMER THAT THREE DAYS POST-OP TO SPAYING PROCEDURE THE OWNER CONTACTED THAT PATIENT HAD BULGING AT THE INCISION SITE. AN X-RAY WAS TAKIN THE SHOWED INTERNALLY THAT SHE HAD A HERNIA WHICH CAUSED HER INTESTINES TO HANG OUT. THE PATIENT IS CURRENTLY DOING FINE. ONE UNUSED BOX BEING RETURNED.
Patient problems: Hernia
MAUDE report 16828005 ↗MalfunctionApr 27, 2023Break; Break
IT WAS REPORTED BY THE CUSTOMER THAT THREE DAYS POST-OP TO SPAYING PROCEDURE THE OWNER CONTACTED THAT PATIENT HAD BULGING AT THE INCISION SITE. AN X-RAY WAS TAKIN THE SHOWED INTERNALLY THAT SHE HAD A HERNIA WHICH CAUSED HER INTESTINES TO HANG OUT. THE PATIENT IS CURRENTLY DOING FINE. ONE UNUSED BOX BEING RETURNED.
Patient problems: Hernia
MAUDE report 16827196 ↗MalfunctionApr 27, 2023Break; Break
IT WAS REPORTED BY THE CUSTOMER THAT THREE DAYS POST-OP TO SPAYING PROCEDURE THE OWNER CONTACTED THAT PATIENT HAD BULGING AT THE INCISION SITE. AN X-RAY WAS TAKIN THE SHOWED INTERNALLY THAT SHE HAD A HERNIA WHICH CAUSED HER INTESTINES TO HANG OUT. THE PATIENT IS CURRENTLY DOING FINE. ONE UNUSED BOX BEING RETURNED.
Patient problems: Hernia
MAUDE report 16827194 ↗MalfunctionApr 27, 2023Break; Break
IT WAS REPORTED BY THE CUSTOMER THAT THREE DAYS POST-OP TO SPAYING PROCEDURE THE OWNER CONTACTED THAT PATIENT HAD BULGING AT THE INCISION SITE. AN X-RAY WAS TAKIN THE SHOWED INTERNALLY THAT SHE HAD A HERNIA WHICH CAUSED HER INTESTINES TO HANG OUT. THE PATIENT IS CURRENTLY DOING FINE. ONE UNUSED BOX BEING RETURNED.
Patient problems: Hernia
MAUDE report 16827189 ↗MalfunctionApr 27, 2023Break; Break
IT WAS REPORTED BY THE CUSTOMER THAT THREE DAYS POST-OP TO SPAYING PROCEDURE THE OWNER CONTACTED THAT PATIENT HAD BULGING AT THE INCISION SITE. AN X-RAY WAS TAKIN THE SHOWED INTERNALLY THAT SHE HAD A HERNIA WHICH CAUSED HER INTESTINES TO HANG OUT. THE PATIENT IS CURRENTLY DOING FINE. ONE UNUSED BOX BEING RETURNED.
Patient problems: Hernia
MAUDE report 16827186 ↗MalfunctionApr 26, 2023Break; Break
IT WAS REPORTED AN ANIMAL UNDERWENT A LUMPECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. SHE TOOK OUT THE FIRST SUTURE AND PULLED THE SUTURE THROUGH, IT BROKE ABOUT 1 INCH FROM THE BASE OF THE NEEDLE. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16814200 ↗MalfunctionJul 1, 2022Material Separation; Material Separation
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE CONTINUES TO FALL OFF NEEDLE AND IS NOT USEABLE THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14892972 ↗MalfunctionSep 2, 2021Material Separation; Material Separation
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12418155 ↗MalfunctionSep 2, 2021Material Separation; Material Separation
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12418150 ↗MalfunctionSep 2, 2021Material Separation; Material Separation
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12418149 ↗MalfunctionMar 2, 2021Break; Break
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE VET THAT THE NEEDLE POPPED OF THE SUTURE ONE MILLIMETER AWAY FROM THE SWAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11399915 ↗MalfunctionNov 4, 2020Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE FROM THE SUTURE DURING INCISION CLOSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10784729 ↗MalfunctionAug 31, 2020Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE SEPARATED FROM THE SUTURE AND FELL INTO BODY CAVITY; THEN THE SUTURE BROKE IN HALF WHILE BEING PULLED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10472355 ↗MalfunctionAug 27, 2020Break; Break
IT WAS REPORTED THAT A DOG UNDERWENT A SPAY PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10459446 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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