PDS PDP370TRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031048195), received between Jan 10, 2018 and Apr 1, 2025 — classified as 3 injuries, 2 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, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT LAST WEEK DURING A LABOR AND DELIVERY CASE, THE NEEDLE POPPED OFF THE SUTURE. NEEDLE WAS REMOVED FROM THE PATIENT. ANOTHER SUTURE WAS OPENED AND THE NEEDLE POPPED OFF AS THE PACKAGE WAS OPENED. CASE WAS COMPLETED WITH A LIKE DEVICE. NO PATIENT HARM WAS REPORTED. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741724 ↗
• InjuryMar 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LTCS ON (B)(6) 2025 AND SUTURE WAS USED. ON POD 6, THE PATIENT EXPERIENCED ACUTE ABDOMINAL PAIN AND POPPING SENSATION AFTER COUGHING FIT. THE PATIENT HAD A COMPLETE DEHISCENCE OF ABDOMINAL WALL INCISION. INTESTINES WERE PROTRUDING THROUGH INCISION SITE. ONSET DATE- 3/9/2025. PATIENT UNDERWENT ABDOMINAL WALL CLOSURE. PATIENT IS CURRENTLY STABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 21665411 ↗
• InjuryMar 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN LTCS ON (B)(6) 2025 AND SUTURE WAS USED. ON THE SAME DAY, (B)(6) 2025, THE PATIENT HAD BLEEDING FROM INCISION SITE. THE SUTURE SNAPPED IN THE MIDLINE OF THE INCISION, OMENTUM EXTRUDED IN THE SUBCUTANEOUS SPACE. PATIENT HAD A FASCIAL DEHISCENCE AND UNDERWENT A REPAIR OF THE FASCIAL DEHISCENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 21664945 ↗
• InjuryMar 7, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT RETURNED FOR WOUND DEHISCENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21547776 ↗
• MalfunctionJan 10, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2017 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE. NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7181009 ↗

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-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-1314-2009 · Feb 2, 2009 · Terminated
  PDS Plus Antibacterial (polydioxanone) Suture Sutures are intended for general soft tissue approximation and/or ligation.