PDS PDP148HRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705031047921), received between Jun 27, 2019 and Mar 10, 2026 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Product Quality Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL THYROIDECTOMY PROCEDURE IN (B)(6) 2026 AND SUTURE WAS USED. IT WAS FOUND THAT THE DIAMETER OF THE SUTURE USED WAS THINNER THAN THE STANDARD ONE WHEN SEWING DURING THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENTS¿ INJURY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560192 ↗
• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN FEBRUARY OF 2026 AND SUTURE WAS USED. THE SUTURE GOT SPLIT IN THE SURGERY. 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 24560173 ↗
• MalfunctionMar 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. THE CUSTOMER FEEDBACK SAID THAT THE SUTURE BROKE EASILY WHEN IT WAS PULLED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24551402 ↗
• MalfunctionAug 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPERFICIAL TUMOR RESECTION SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE SURGICAL PROCEDURE, THE SUTURE BROKE ON ITS OWN, AFFECTING THE SURGICAL PROGRESS. THE SUTURE WAS REPLACED AND SUTURED AGAIN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22833668 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN THYROIDECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE SKIN. POST-OP, THE PATIENT EXPERIENCED POOR WOUND HEALING. THE PATIENT HAD INCISION INFECTION REPEATEDLY AND DID NOT HEAL WELL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 21547697 ↗
• MalfunctionNov 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SACRAL AND CAUDAL LESION RESECTION SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THIS CASE IS FROM HEALTH AUTHORITY. AT 10:10 AM, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED WHEN THE WOUND CAVITY WAS SUTURED WITH SUTURE AFTER THE PATIENT'S SACROCOCCYGEAL LESION WAS REMOVED. THE SURGEON IMMEDIATELY INFORMED THE INSTRUMENT NURSE AND CONFIRMED THE INTEGRITY OF THE SUTURE NEEDLE WITH THE CIRCULATING NURSE. 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 20602233 ↗
• InjuryOct 18, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY DUE TO SEBORRHEIC KERATOSIS OF THE ANTERIOR CHEST ON (B)(6) 2024 AND SUTURE WAS USED. ON THE SECOND DAY, THE SUTURE WAS FOUND TO BE BROKEN WHEN THE DRESSING WAS CHANGED. SYMPTOMATIC TREATMENT WAS GIVEN TO PREVENT INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Wound Dehiscence

  MAUDE report 20483129 ↗
• MalfunctionSep 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC LIVER AND GALLBLADDER PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT DURING SURGERY, THE NEEDLE BROKE DURING SEWING. THEN CT WAS USED TO LOOK FOR THE BROKEN NEEDLE BUT FAILED. THE PATIENT IS CURRENTLY STABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20181537 ↗
• MalfunctionJul 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN SUTURING WOUND. SO, A NEW NEEDLE WAS IMMEDIATELY REPLACED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711017 ↗
• MalfunctionJun 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHEN THE DOCTOR PULLED OUT THE SUTURE WITH A NEEDLE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED . CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19606490 ↗
• MalfunctionJun 24, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NURSE NOTICED THAT EACH BOX WAS FOUND A SMALL HOLE ON THE PRIMARY PACKAGE. THE NURSE CONSIDER IF THERE WAS RISK OF INFECTION NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19593631 ↗
• MalfunctionJun 24, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NURSE NOTICED THAT EACH BOX WAS FOUND A SMALL HOLE ON THE PRIMARY PACKAGE. THE NURSE CONSIDER IF THERE WAS RISK OF INFECTION NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19593624 ↗
• MalfunctionFeb 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING IN SURGERY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18663663 ↗
• MalfunctionFeb 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE WHEN SEWING. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18647342 ↗
• MalfunctionMay 30, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE IT WAS REPORTED THAT THERE WAS NO NEEDLE BUT ONLY SUTURE IMMEDIATELY ONCE OPENED THE PACKAGE. BESIDES, THE SUTURE WAS SHORTER THAN THE STANDARD ONE. 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 17019810 ↗
• MalfunctionOct 1, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE DURING KNOTTING IN SURGERY. 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 15523957 ↗
• MalfunctionJun 29, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE DAMAGED WHEN SEWING IN AN UNKNOWN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14857161 ↗
• MalfunctionFeb 25, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT WHIPPLE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING AN ANASTOMOSES, THE SUTURE BROKE AND WAS SAID TO BE "GRITTY" BY THE ATTENDING SURGEON. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378553 ↗
• MalfunctionFeb 25, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT WHIPPLE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING AN ANASTOMOSES, THE SUTURE BROKE AND WAS SAID TO BE "GRITTY" BY THE ATTENDING SURGEON. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378549 ↗
• MalfunctionFeb 25, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT WHIPPLE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING AN ANASTOMOSES, THE SUTURE BROKE AND WAS SAID TO BE "GRITTY" BY THE ATTENDING SURGEON. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378548 ↗
• MalfunctionJun 27, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HYPOSPADIAS REPAIR ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. A LIKE DEVICE WAS USED TO COMPLETE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8741908 ↗

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.