PDS PDP880GRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031048669), received between Dec 12, 2018 and May 12, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY THE SALES REP THAT ON (B)(6) THEY HAD THE TIP OF A NEEDLE BREAK DURING A PROCEDURE. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153563 ↗
• MalfunctionJul 26, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING REVISION IN THE PHARMACY THE SUTURE PACKING IS INFLATED AND ANOMALIES ARE PRESENT IN THIS PACKING IN RELATION TO THE USUAL PRODUCT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108680 ↗
• MalfunctionFeb 24, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LIVER RESECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE ABOUT AN EIGHTH OF AN INCH FROM THE SWEDGE WHILE SUTURING THE FACIA. THE BROKEN PIECE OF THE NEEDLE WAS RETRIEVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11372046 ↗
• MalfunctionDec 3, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND CYSTOSCOPY ON (B)(6) 2020 AND SUTURE WAS USED. UPON COMPLETION OF THE SURGERY AND CLOSING THE INCISION, THE TIP OF THE NEEDLE BROKE OFF IN THE PATIENT. THE TIP WAS NOT LOCATED, BUT THE WOUND WAS IRRIGATED. NO X-RAY WAS TAKEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10938036 ↗
• MalfunctionNov 3, 2020Break; Material Separation

  MIDDLE AGED FEMALE WITH HISTORY OF PELVIC PAIN, VAGINAL BLEEDING AND FIBROIDS. PRESENTED TO OPERATING ROOM FOR SCHEDULED ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND CYSTOSCOPY. UPON COMPLETION OF THE SURGERY AND CLOSING THE INCISION, THE TIP OF THE 1 PDS LOOPED SUTURE BROKE OFF IN THE PATIENT. THE TIP WAS NOT LOCATED. WOUND WAS IRRIGATED, NO XRAY TAKEN. NO KNOWN HARM TO PATIENT. BROKEN DEVICE WAS NOT SAVED. PICTURES ARE REPRESENTATION OF WHAT WAS USED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10777947 ↗
• MalfunctionDec 12, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE IN 2018 AND A SUTURE WAS USED. DURING SURGERY, THE NEEDLE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8157119 ↗

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-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-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.