PDS PDP990GRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10705031048713), received between Feb 20, 2018 and May 12, 2026 — classified as 3 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150943 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING C-SECTION PROCEDURE, THE SUTURE WAS BREAKING OFF. THERE WAS A DELAY IN THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301909 ↗
• MalfunctionSep 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE NEEDLE WAS DEEMED DEFECTIVE UPON USAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977507 ↗
• MalfunctionJun 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY THE SALES REP THAT THE NEEDLE KEEPS POPPING OFF THE SUTURE. RETURNING 24 IN TOTAL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203915 ↗
• MalfunctionJun 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY THE SALES REP THAT THE NEEDLE KEEPS POPPING OFF THE SUTURE. RETURNING 24 IN TOTAL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203911 ↗
• MalfunctionApr 2, 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, THE SUTURE PULLED OFF THE NEEDLE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753701 ↗
• MalfunctionApr 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREAS PROCEDURE ON (B)(6) 2025, AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN THE SURGERY. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. 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 21752254 ↗
• MalfunctionApr 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREAS PROCEDURE ON (B)(6) 2025, AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN THE SURGERY. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. 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 21752239 ↗
• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN INTO TWO. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ANY FRAGMENTS GENERATED WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805554 ↗
• InjuryDec 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2023 AND SUTURE WAS USED TO SEW MUSCLE FASCIA TISSUE. ABOUT 7 DAYS AFTER THE SURGERY, THE WOUND WAS FOUND WITH INFECTION. THEN DRAINAGE WAS PERFORMED ON THE WOUND. THE PATIENT IS CURRENTLY STABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 18392113 ↗
• InjuryDec 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2023 AND SUTURE WAS USED TO SEW MUSCLE FASCIA TISSUE. ABOUT 7 DAYS AFTER THE SURGERY, THE WOUND WAS FOUND WITH INFECTION. THEN THE SUTURE WAS REMOVED. THE PATIENT IS CURRENTLY STABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 18392111 ↗
• InjuryDec 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2023 AND SUTURE WAS USED TO SEW MUSCLE FASCIA TISSUE. ABOUT 7 DAYS AFTER THE SURGERY, THE WOUND WAS FOUND WITH INFECTION. THEN DRAINAGE WAS PERFORMED ON THE WOUND. THE PATIENT IS CURRENTLY STABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 18392110 ↗
• MalfunctionJun 2, 2023Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT IT WAS IMMEDIATELY FOUND ON (B)(6) 2023 THAT THERE HAD BEEN FOREIGN MATTER IN THE NEWLY DISPENSED SUTURE DURING NORMAL CHECKING BY THE HOSPITAL. THE PACKAGE ISN'T OPENED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17052589 ↗
• MalfunctionMay 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COLECTOMY PROCEDURE ON (B)(6) 2023 AND BARBED 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 CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. 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 16942591 ↗
• MalfunctionMay 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COLECTOMY PROCEDURE ON (B)(6) 2023 AND BARBED 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 CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. 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 16942590 ↗
• MalfunctionApr 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COLECTOMY PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16780739 ↗
• MalfunctionApr 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COLECTOMY PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY AND THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16780692 ↗
• MalfunctionJan 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ECTOPIC PREGNANCY PROCEDURE IN (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT TWO SUTURES BROKE WHILE TYING. A THIRD SUTURE WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16275418 ↗
• MalfunctionJan 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ECTOPIC PREGNANCY PROCEDURE IN DECEMBER 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT TWO SUTURES BROKE WHILE TYING. A THIRD SUTURE WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16275416 ↗
• MalfunctionJan 26, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRECTOMY PROCEDURE ON (B)(6) 2021 AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11232678 ↗
• MalfunctionJan 26, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRECTOMY PROCEDURE ON (B)(6) 2021 AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11232627 ↗
• MalfunctionDec 16, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE OFF OF THE SUTURE TOWARDS THE END OF THE CLOSURE. THE TIP WAS LOCATED AND REMOVED FROM THE PATIENT. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9474646 ↗
• MalfunctionFeb 20, 2019Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2018 AND SUTURE WAS USED. THE NEEDLE BROKE DURING USE BY SURGEON. ALL PIECES OF NEEDLE RETRIEVED. NO ADVERSE PATIENT CONSEQUENCE WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8355710 ↗
• MalfunctionFeb 20, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE CLOSING FASCIA, THE ONE-QUARTER END OF THE NEEDLE CLOSEST TO THE SUTURE BROKE IN TWO WHILE THE DOCTOR WAS USING THE SUTURE IN THE STANDARD DESIGNED MANNER, UTILIZING A NEEDLE DRIVER. A BROKEN PORTION OF THE NEEDLE FELL INTO THE PATIENT'S ABDOMINAL CAVITY BUT WAS FULLY RETRIEVED BY THE DOCTOR. ALL PIECES OF THE SUTURE NEEDLE WERE REMOVED AND ACCOUNTED FOR. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7282236 ↗

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.