PDS PDPB347Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031048836), received between Nov 1, 2019 and Aug 31, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERVICAL ENLARGEMENT ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE FASCIA. IT WAS REPORTED THAT FOR THE SUBCUTANEOUS DERMIS, EPIDERMAL NYLON (BULLET NEEDLE, CROWNJUN¿S PRODUCT) WAS ALSO USED. POSTOPERATIVE REDNESS AND OTHER SYMPTOMS WERE OBSERVED, AND INFECTION OCCURRED EVENTUALLY. THE REDNESS OCCURRED A FEW DAYS AFTER SURGERY, POST-OP, IN THE WARD / ICU, THE PATIENT GOT INFECTED, AND A RE-OPERATION WAS PERFORMED ABOUT ONE WEEK AFTER THE SURGERY. AFTER REOPERATION, NEGATIVE PRESSURE CLOSURE THERAPY WAS DONE. IT WAS STATED THAT THE PATIENT WAS A BIT OF A FILTHY PATIENT, AND THIS WAS THE FIRST TIME OF THIS SURGERY IN THE HOSPITAL. THE SURGEON¿S OPINION ABOUT CAUSAL RELATIONSHIP BETWEEN THE PRODUCT AND EVENT WAS REPORTED AS NO. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 17666695 ↗
• MalfunctionNov 1, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. WHEN HOLDING THE NEEDLE WITH A NEEDLE-HOLDER, THE NEEDLE WAS BROKEN AT THE SWAGE PART. NO BROKEN PIECES FELL INTO THE PATIENT. SINCE THE SWAGE PART WAS WET/ USED, IT HAS BEEN ALREADY DISCOLORED. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9269102 ↗

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.