PDS PDP358TRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031048171), received between Jul 10, 2018 and Sep 17, 2024 — classified as 1 injury, 11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. UPON VISUAL ASSESSMENT OF THE SAMPLE, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE BARREL HOLE WAS EXAMINED, AND REMNANT OF SUTURE WAS OBSERVED. THE SUTURES CANNOT BE DISPENSED SINCE HAVE BEGUN THE DEGRADATION PROCESS THIS CONDITION PROBABLY CAUSED THE DETACHED NEEDLE. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE LOT OF THE IP IS UNAVAILABLE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20242061 ↗
• MalfunctionJul 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAVH PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE. THE TEAM WAS UNABLE TO INITIALLY LOCATE THE SUTURE NEEDLE TIP. THE PATIENT WAS X-RAYED AS PER POLICY AND PROTOCOL. THE TIP WAS LOCATED AND RETRIEVED BY THE SURGEON. SUTURE BOX WAS REMOVED FROM SET UP ROOM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19841824 ↗
• MalfunctionMar 29, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON 12-DECEMBER-2023 AND SUTURE WAS USED. DURING THE SURGERY, WHEN THE DOCTOR USED THE SUTURE TO PULL THE PATIENT'S MUSCLES, THE SUTURE BROKE AND WAS DISCARDED AND NOT USED. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19006025 ↗
• MalfunctionApr 26, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING USE ON THE PATIENT IT WAS NOTED THAT THE NEEDLE BROKE. THE NEEDLE BROKE WHEN SEWING IN SURGERY. THE DOCTOR IMMEDIATELY REMOVED THE BROKEN PART AND SUCCESSFULLY ANASTOMOSED IT WITH THE BROKEN END. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815341 ↗
• MalfunctionApr 4, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED 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 16678633 ↗
• MalfunctionFeb 10, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN SEWING. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16354537 ↗
• MalfunctionFeb 10, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE BROKE WHEN SEWING IN SURGERY. THEY TOOK OUT THE BROKEN PART AND FIT IT WITH THE BROKEN END SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16351517 ↗
• MalfunctionJan 5, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE WHEN SEWING IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16108531 ↗
• MalfunctionFeb 23, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021, AND SUTURE WAS USED. THE SUTURE BROKE AT THE TIME OF KNOTTING WHEN SEWING. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11368928 ↗
• InjuryDec 11, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A STUMP RECONSTRUCTION PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIGNS OF (B)(6) WITHIN THREE DAYS AFTER DISCHARGE. ELEVEN DAYS POST PROCEDURE, AN ADDITIONAL PROCEDURE WAS PERFORMED WHERE THE WOUND WAS DRAINED, DEBRIDEMENT AND A DRAIN WAS PLACED WHICH WAS SECURED WITH "CLOTH LIKE" SUTURES WHICH CAUSED NO ISSUES. THE CAUSE OF THE (B)(6) IS UNKNOWN. THE PATIENT EXPERIENCED SIX STITCH ABSCESSES, SUTURES NOT DISSOLVING AND POKING THROUGH OR ERUPTING THE INCISION. THE PATIENT EXPERIENCED MULTIPLE INFECTIONS AND WAS TREATED WITH MULTIPLE ANTIBIOTICS WITH NO RESOLUTION. THE PATIENT EXPERIENCED RASH. THE SUTURES WERE REMOVED ON (B)(6) 2018 AND THE INCISION WAS RE-CLOSED WITH STAPLES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess; No Code Available; Not Applicable; Rash; Unspecified Infection

  MAUDE report 8153263 ↗
• MalfunctionJul 10, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A C-SECTION PROCEDURE ON A PATIENT ON (B)(6) 2018 SUTURE WAS USED. WHILE CLOSING THE TISSUE THE NEEDLE POPPED OFF THE SUTURE. ANOTHER SUTURE WAS OPENED, THE NEEDLE POPPED OFF OF THE SECOND SUTURE AS WELL. BOTH NEEDLES WERE RECOVERED WITH NO PATIENT INCIDENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO DEVICE WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7673983 ↗
• MalfunctionJul 10, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A C-SECTION PROCEDURE ON (B)(6) 2018 SUTURE WAS USED ON A PATIENT. WHILE CLOSING THE TISSUE THE NEEDLE POPPED OFF THE SUTURE. ANOTHER SUTURE WAS OPENED, THE NEEDLE POPPED OFF OF THE SECOND SUTURE AS WELL. BOTH NEEDLES WERE RECOVERED WITH NO PATIENT INCIDENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO DEVICE WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7673425 ↗

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