PDS PDP496GRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031048430), received between Jun 30, 2021 and Jun 26, 2024 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

9 other recalls cover devices cleared under the same FDA submission (K061037); 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN USING, TIE THE KNOT UNTIL HALF OF THE SUTURE BREAKS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19616317 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN USING, TIE THE KNOT UNTIL HALF OF THE SUTURE BREAKS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19616063 ↗
• MalfunctionFeb 26, 2024Material Separation; Difficult to Open or Remove Packaging Material; Material Separation; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE-SUTURE COULD NOT BE TAKEN OUT OF THE PACKAGE SMOOTHLY AND ALSO THE NEEDLE WAS EASILY DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784026 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ADOLESCENT IDIOPATHIC SCOLIOSIS PROCEDURE IN (B)(6) 2023 AND SUTURE WAS USED ON THE EPIDERMIS. AFTER THE SURGERY, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, AND AN OVAL BURN-LIKE SKIN ULCER DEVELOPED AROUND A PART OF THE WOUND (APPROXIMATELY 4-5 CM. THE ENTIRE WOUND WAS MORE THAN 20 CM). VISUALLY, IT LOOKED LIKE A SKIN ULCER AFTER 2 - 3 DEGREES BURN. MSSA WAS DETECTED FROM THE SURFACE LAYER, SO ANTIBIOTIC TREATMENT AND WOUND TREATMENT WERE PERFORMED TO TREAT THE SURFACE SSI, BUT THE CONDITION DID NOT IMPROVE. IN (B)(6), THE SAME AREA WAS TRIMMED, EXCISED, AND SUTURED AGAIN. INTRAOPERATIVE FINDINGS REVEALED NO SUBCUTANEOUS ABSCESS OR DEEP INFECTION. THE PATIENT HAS BEEN EXAMINED BY A PLASTIC SURGEON AND A DERMATOLOGIST, AND THE SURGEON IS CURRENTLY INVESTIGATING THE CAUSE. THE SURGEON OPINES THE MOST LIKELY CAUSE IS AN ALLERGY TO THE SUTURES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Ulcer

  MAUDE report 18540608 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE DUE TO AN OVAL BURN-LIKE SKIN ULCER IN (B)(6) 2023 AND SUTURE WAS USED ON THE EPIDERMIS. THERE WAS NO PROBLEM WITH THE PATIENT'S CONDITION FOR ABOUT TWO WEEKS AFTERWARD, BUT THE SKIN ULCER RECURRED AFTER THAT, AND THE PATIENT IS CURRENTLY HOSPITALIZED AND UNDERGOING TREATMENT. THE PATIENT HAS BEEN EXAMINED BY A PLASTIC SURGEON AND A DERMATOLOGIST, AND THE SURGEON IS CURRENTLY INVESTIGATING THE CAUSE. THE SURGEON OPINES THE MOST LIKELY CAUSE IS AN ALLERGY TO THE SUTURES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Ulcer

  MAUDE report 18540607 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ADOLESCENT IDIOPATHIC SCOLIOSIS PROCEDURE IN (B)(6) 2023 AND SUTURE WAS USED ON THE EPIDERMIS. THE PATIENT DEVELOPED AN OVAL BURN-LIKE SKIN ULCER. THE PATIENT IS CURRENTLY UNDERGOING TREATMENT AS AN OUTPATIENT. THE SURGEON OPINES THE MOST LIKELY CAUSE IS AN ALLERGY TO THE SUTURES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Ulcer

  MAUDE report 18540606 ↗
• MalfunctionNov 20, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2023 AND SUTURE WAS USED. DERMAL SUTURE WAS PERFORMED USING THE PRODUCT WITH INSTRUMENTED KNOT. AT ABOUT 2ND STITCHES, WHEN THE NEEDLE WAS PULLED WITH A NEEDLE HOLDER, THE SUTURE WAS BROKEN. THE PRODUCT WAS USED ON DERMIS. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18170930 ↗
• MalfunctionFeb 17, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, ALTHOUGH IT WAS USED WITH THE USUAL WAY AND NO EXTRA FORCE WAS APPLIED, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13553401 ↗
• MalfunctionNov 11, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE NEAR THE SWAGE PART DURING INTERRUPTED SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12799237 ↗
• MalfunctionSep 29, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12548487 ↗
• MalfunctionAug 25, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INTERBODY FUSION SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CAME OFF OF THE SWAGE DURING SUTURING. NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365371 ↗
• MalfunctionAug 25, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INTERBODY FUSION SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CAME OFF OF THE SWAGE DURING SUTURING OF DERMIS. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365192 ↗
• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY PROCEDURE ON AN UNKNOWN DATE IN 2020 AND SUTURE WAS USED. IT WAS REPORTED BY A FRIEND THAT THE PATIENT EXPERIENCED A REACTION LIKELY DUE TO THE SUTURE. THE PATIENT HAS BEEN BACK TO THE HOSPITAL TWICE SINCE THE PROCEDURE TO HAVE THE WOUND CLEANED OUT AND RE-SUTURED DUE TO SEVERE INFECTION. THE PATIENT IS CURRENTLY STABLE AND SEEMS TO BE IMPROVING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Local Reaction; Pain; Unspecified Infection

  MAUDE report 12095580 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061037. 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-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-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-1340-2018 · Jan 10, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
• Z-1338-2018 · Jan 10, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-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.