PDS PDP259HRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10705031047952), received between Jul 12, 2019 and Dec 12, 2020 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Break” (30 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 10, 2023Open, Classified

   Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.

   Z-2616-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MID STRAND. IT WAS REPORTED THAT THE ISSUE OCCURRED WHILE SUTURING DEEPER BREAST TISSUE UNDER MINIMAL TENSION. THE PHYSICIAN REPORTED SHE WAS NOT APPLYING SIGNIFICANT FORCE TO SUTURE AT THE TIME OF BREAKAGE. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10995735 ↗
• MalfunctionDec 12, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MID STRAND. IT WAS REPORTED THAT THE ISSUE OCCURRED WHILE SUTURING DEEPER BREAST TISSUE UNDER MINIMAL TENSION. THE PHYSICIAN REPORTED SHE WAS NOT APPLYING SIGNIFICANT FORCE TO SUTURE AT THE TIME OF BREAKAGE. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10995727 ↗
• MalfunctionDec 12, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MID STRAND. IT WAS REPORTED THAT THE ISSUE OCCURRED WHILE SUTURING DEEPER BREAST TISSUE UNDER MINIMAL TENSION. THE PHYSICIAN REPORTED SHE WAS NOT APPLYING SIGNIFICANT FORCE TO SUTURE AT THE TIME OF BREAKAGE. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10995725 ↗
• MalfunctionDec 12, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MID STRAND. IT WAS REPORTED THAT THE ISSUE OCCURRED WHILE SUTURING DEEPER BREAST TISSUE UNDER MINIMAL TENSION. THE PHYSICIAN REPORTED SHE WAS NOT APPLYING SIGNIFICANT FORCE TO SUTURE AT THE TIME OF BREAKAGE. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10995710 ↗
• MalfunctionDec 12, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MID STRAND. IT WAS REPORTED THAT THE ISSUE OCCURRED WHILE SUTURING DEEPER BREAST TISSUE UNDER MINIMAL TENSION. THE PHYSICIAN REPORTED SHE WAS NOT APPLYING SIGNIFICANT FORCE TO SUTURE AT THE TIME OF BREAKAGE. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10995708 ↗
• MalfunctionDec 12, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MID STRAND. IT WAS REPORTED THAT THE ISSUE OCCURRED WHILE SUTURING DEEPER BREAST TISSUE UNDER MINIMAL TENSION. THE PHYSICIAN REPORTED SHE WAS NOT APPLYING SIGNIFICANT FORCE TO SUTURE AT THE TIME OF BREAKAGE. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10995704 ↗
• MalfunctionDec 12, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MID STRAND. IT WAS REPORTED THAT THE ISSUE OCCURRED WHILE SUTURING DEEPER BREAST TISSUE UNDER MINIMAL TENSION. THE PHYSICIAN REPORTED SHE WAS NOT APPLYING SIGNIFICANT FORCE TO SUTURE AT THE TIME OF BREAKAGE. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10995702 ↗
• MalfunctionDec 8, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN BREAST SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS BRITTLE AND BROKE UNDER MINIMAL TENSION WHILE SUTURE DEEPER BREAST TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10972378 ↗
• MalfunctionDec 8, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN BREAST SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS BRITTLE AND BROKE UNDER MINIMAL TENSION WHILE SUTURE DEEPER BREAST TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10972364 ↗
• MalfunctionDec 8, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN BREAST SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS BRITTLE AND BROKE UNDER MINIMAL TENSION WHILE SUTURE DEEPER BREAST TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10972304 ↗
• MalfunctionDec 8, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN BREAST SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS BRITTLE AND BROKE UNDER MINIMAL TENSION WHILE SUTURE DEEPER BREAST TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10972284 ↗
• MalfunctionDec 8, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN BREAST SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS BRITTLE AND BROKE UNDER MINIMAL TENSION WHILE SUTURE DEEPER BREAST TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10972281 ↗
• MalfunctionDec 8, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN BREAST SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS BRITTLE AND BROKE UNDER MINIMAL TENSION WHILE SUTURE DEEPER BREAST TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10972272 ↗
• MalfunctionDec 8, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BREAST PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS FOUND TO BE BRITTLE AND BROKE MID-STRAND UNDER MINIMAL TENSION WHILE SUTURING DEEPER BREAST TISSUE. IT WAS REPORTED THAT SIGNIFICANT FORCE WAS NOT APPLIED AT THE TIME OF SUTURE BREAKAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10971359 ↗
• MalfunctionDec 8, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BREAST PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS FOUND TO BE BRITTLE AND BROKE MID-STRAND UNDER MINIMAL TENSION WHILE SUTURING DEEPER BREAST TISSUE. IT WAS REPORTED THAT SIGNIFICANT FORCE WAS NOT APPLIED AT THE TIME OF SUTURE BREAKAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10971357 ↗
• MalfunctionDec 8, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BREAST PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS FOUND TO BE BRITTLE AND BROKE MID-STRAND UNDER MINIMAL TENSION WHILE SUTURING DEEPER BREAST TISSUE. IT WAS REPORTED THAT SIGNIFICANT FORCE WAS NOT APPLIED AT THE TIME OF SUTURE BREAKAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10971305 ↗
• MalfunctionDec 8, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BREAST PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS FOUND TO BE BRITTLE AND BROKE MID-STRAND UNDER MINIMAL TENSION WHILE SUTURING DEEPER BREAST TISSUE. IT WAS REPORTED THAT SIGNIFICANT FORCE WAS NOT APPLIED AT THE TIME OF SUTURE BREAKAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10971299 ↗
• MalfunctionDec 8, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BREAST PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS FOUND TO BE BRITTLE AND BROKE MID-STRAND UNDER MINIMAL TENSION WHILE SUTURING DEEPER BREAST TISSUE. IT WAS REPORTED THAT SIGNIFICANT FORCE WAS NOT APPLIED AT THE TIME OF SUTURE BREAKAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10971232 ↗
• MalfunctionDec 7, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BREAST SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS BRITTLE AND BROKE UNDER MINIMAL TENSION WHILE SUTURE DEEPER BREAST TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10963588 ↗
• MalfunctionDec 7, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BREAST SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS BRITTLE AND BROKE UNDER MINIMAL TENSION WHILE SUTURE DEEPER BREAST TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10963583 ↗
• MalfunctionDec 7, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BREAST SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS BRITTLE AND BROKE UNDER MINIMAL TENSION WHILE SUTURE DEEPER BREAST TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10963582 ↗
• MalfunctionDec 7, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BREAST SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS BRITTLE AND BROKE UNDER MINIMAL TENSION WHILE SUTURE DEEPER BREAST TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10963573 ↗
• MalfunctionDec 7, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BREAST SURGERY ON (B)(6)2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS BRITTLE AND BROKE UNDER MINIMAL TENSION WHILE SUTURE DEEPER BREAST TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10963569 ↗
• MalfunctionNov 20, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MID STRAND DURING PROCEDURE. THE PHYSICIAN REPORTED SHE WAS NOT APPLYING SIGNIFICANT FORCE TO SUTURE AT THE TIME OF BREAKAGE. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10879876 ↗
• MalfunctionNov 20, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MID STRAND DURING PROCEDURE. THE PHYSICIAN REPORTED SHE WAS NOT APPLYING SIGNIFICANT FORCE TO SUTURE AT THE TIME OF BREAKAGE. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10879867 ↗

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-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-1339-2018 · Jan 10, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 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-1314-2009 · Feb 2, 2009 · Terminated
  PDS Plus Antibacterial (polydioxanone) Suture Sutures are intended for general soft tissue approximation and/or ligation.