PDS PDP712DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031218758), received between Jun 12, 2025 and Apr 7, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

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 7, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NECK PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN HEAD AND NECK SURGERY, 4-0 PDS WAS PREPARED BY STICKING INTO A NEEDLE SPONGE, BUT THE DOCTOR TOLD A NURSE TO USE A DIFFERENT TYPE OF NEEDLE/SUTURE WHEN THE NURSE HAD PREPARED 4-0 PDS TO BE USED IN SURGERY AND HOLD THE NEEDLE WITH THE NEEDLE-HOLDER. THE DOCTOR TOLD THE NURSE TO USE 4-0 PDS AGAIN, AND WHEN THE NURSE HOLD IT WITH THE NEEDLE HOLDER AND HANDED IT TO THE DOCTOR, THE DOCTOR POINTED OUT THAT THE TIP OF THE NEEDLE WAS MISSING. THE NURSE CHECKED THE NEEDLE SPONGE THAT HAD BEEN USING, BUT THEY COULDN'T FIND IT. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800972 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE NEEDLE TIP WAS BROKEN. THE NEEDLE TIP WAS LOST BUT FOUND BY X-RAY, AND IT WAS REMOVED. THIS PRODUCT IS IN THE SOT TRAY. IT WAS A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888898 ↗
• MalfunctionJul 31, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE SEAL WAS FOUND UNTIGHT WHEN IT WAS OPENED TO PREPARE FOR SURGERY. THE CUSTOMER SUSPECTED THAT THE SEAL OF THE PACKAGE ISN'T TIGHT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680700 ↗
• InjuryJun 12, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNILATERAL THYROIDECTOMY UNDER THE CLAVICLE ON (B)(6) 2024 AND SUTURE WAS USED TO SEW THE MUSCLES AND SUBCUTANEOUS TISSUE INTERMITTENTLY. THE REMAINING PART OF THE SAME SUTURE WAS USED FOR CONTINUOUS INTRADERMAL SEWING OF THE SKIN. THE INTRAOPERATIVE OPERATION WAS SMOOTH, AND NO INSTRUMENT MALFUNCTIONS OR PATIENT INJURIES WERE REPORTED. THREE MONTHS AFTER SURGERY (EXACT DATE UNKNOWN), A FOLLOW-UP EXAMINATION REVEALED SKIN PIGMENTATION. IN (B)(6) 2024 (EXACT DATE UNKNOWN), THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING THAT THERE WERE STILL BLUE PURPLE RESIDUES ON THE NECK SKIN INCISION, AFFECTING AESTHETICS. IN (B)(6) 2025, THE PATIENT ONCE AGAIN COMPLAINED THAT THE BLUE PURPLE RESIDUE HAD NOT DISAPPEARED. THE DOCTOR PRELIMINARILY DETERMINED THAT IT WAS CAUSED BY THE USE OF SUTURE MATERIAL PIGMENT PRECIPITATION DURING SURGERY, AND SUBSEQUENTLY PLANNED TO PERFORM LASER OR SECONDARY SURGERY TO REMOVE THE STAINED EPIDERMIS. NO SUBSEQUENT ADVERSE EVENT REPORTS HAVE BEEN RECEIVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Local Reaction

  MAUDE report 22199787 ↗
• InjuryJun 12, 2025Material Integrity Problem; Material Integrity Problem

  SUTURE DYE RESIDUE ON SKIN. IT'S REPORTED THAT THE SUTURE WAS USED IN SUBCUTANEOUS AND SKIN LAYERS DURING OPEN THYROIDECTOMY IN THE DEPARTMENT OF GENERAL SURGERY ON (B)(6) 2023. HOWEVER, IN (B)(6) 2024, PATIENT COMPLAINED TO HOSPITAL THERE WERE BLUE-PURPLE RESIDUE IN THE NECK INCISION, AFFECTING THE AESTHETICS. AND THEN IN (B)(6) 2025, THE PATIENT COMPLAINED AGAIN THAT BLUE-PURPLE RESIDUE DIDN'T DISAPPEAR AND PROVIDED RECENT PHOTO TAKEN BY (B)(6) 2025, CLAIMED FOR COMPENSATION. THE EVENT INVOLVED LOT WOULD BE SMMHTT OR SMMERL.

  Patient problems: Local Reaction

  MAUDE report 22199786 ↗

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-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-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.