PDS PDP359TRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031048188), received between Jul 17, 2023 and Oct 15, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

9 other recalls cover devices cleared under the same FDA submission (K061037, K212380, K243897); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE BROKE IN HALF. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285433 ↗
• MalfunctionMar 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE BROKE OFF SUTURE STRAND. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587520 ↗
• MalfunctionNov 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT OPEN GENERAL SURGERY IN 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, THE STRAND OF SUTURE BROKE WHILE CLOSING THE FASCIA. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20775471 ↗
• MalfunctionNov 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT OPEN GENERAL SURGERY IN 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, THE STRAND OF SUTURE BROKE WHILE CLOSING THE FASCIA. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20774636 ↗
• MalfunctionNov 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT EXPLORATORY LAPAROTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE STRAND OF SUTURE BROKE WHILE CLOSING THE FASCIA. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20772489 ↗
• MalfunctionNov 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT EXPLORATORY LAPAROTOMY PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE STRAND OF SUTURE BROKE WHILE CLOSING THE FASCIA. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20772410 ↗
• MalfunctionNov 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT EXPLORATORY LAPAROTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE STRAND OF SUTURE BROKE WHILE CLOSING THE FASCIA. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20772236 ↗
• MalfunctionAug 14, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UTERINE SUSPENSION SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE UTERINE SUSPENSION SURGERY, THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17540552 ↗
• MalfunctionJul 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17332407 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061037, K212380, K243897. 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-1339-2018 · Jan 10, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 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-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.