PDS PDP468HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031048379), received between Aug 29, 2019 and Apr 20, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

9 other recalls cover devices cleared under the same FDA submission (K061037, K212380); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Use of Device Problem; Component Misassembled

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT DURING THE PROCEDURE, THE PHYSICIAN REQUESTED A TAPERING SUTURE. HOWEVER, THE SUTURE PROVIDED WAS NOT A TAPERING SUTURE AND WAS FOUND TO BE EXPIRED. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932293 ↗
• MalfunctionApr 23, 2024Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN LAPAROTOMY CLOSURE PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE IN THE MIDDLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 19162363 ↗
• MalfunctionFeb 13, 2024Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER REPORTED THAT DURING A K-9 SPAY PROCEDURE THE SURGEON (WHOSE USED SAME PRODUCT FOR YEARS) NOTED THE STITCHING PART IS WEEK AND FEELS LIKE FLIMSY MATERIAL. THREAD POPS IN HALF WHEN TRYING TO MANEUVER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699870 ↗
• MalfunctionAug 29, 2019Break; Break

  IT WAS REPORTED THAT A DOG UNDERWENT A LAPARATOMY FOR JEJUNAL INVAGINATION ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS USED CONTINUOUSLY TO APPROXIMATE THE MUSCLE LAYERS OF THE STERNO-UMBILICAL MEDIAN INCISION. ONE DAY POST OP THE SUTURE HAD BROKEN IN ONE OR MORE PLACES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8946413 ↗
• MalfunctionAug 29, 2019Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ECTOPIC URETHRA REMEDIATION PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS USED CONTINUOUSLY TO APPROXIMATE THE MUSCLE LAYERS OF THE STERNO-UMBILICAL MEDIAN INCISION. ONE DAY POST OP, THE SUTURE BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8945480 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061037, K212380. One submission often covers many models, so check the product and lot details in each record.

• Z-2147-2024 · May 10, 2024 · Open, Classified
  PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in oph
• Z-1571-2023 · Mar 31, 2023 · Open, Classified
  PDS Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatri
• Z-1135-2019 · Mar 12, 2019 · Terminated
  VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 UND VICRYL PLUS SUTURE 18"(45CM) 0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 VIO) VICRYL PLUS SU
• Z-2533-2018 · Jun 8, 2018 · Terminated
  PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)
• Z-2532-2018 · Jun 8, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (GTIN 10705031203983)
• Z-1338-2018 · Jan 10, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
• Z-1340-2018 · Jan 10, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
• Z-1339-2018 · Jan 10, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle
• Z-1314-2009 · Feb 2, 2009 · Terminated
  PDS Plus Antibacterial (polydioxanone) Suture Sutures are intended for general soft tissue approximation and/or ligation.