PDS PDP422HRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031048263), received between May 15, 2019 and Apr 8, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL FUSION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING USE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THE PRODUCT HAS BEEN DISCARDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821012 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL FUSION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING USE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THE PRODUCT HAS BEEN DISCARDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821008 ↗
• InjuryNov 27, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON (B)(6) 2023 AND SUTURE WAS USED ON THE SUBCUTANEOUS LAYER. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE BODY PART. THE SURGEON REALIZED THAT THE BROKEN NEEDLE WAS SOMEWHERE IN THE PATIENT¿S BODY BUT COULDN¿T FIND IT AND CLOSED THE WOUND. AFTER THAT, THE PATIENT WAS EXAMINED USING AN INSTRUMENT CALLED CALM AND THE SURGEON GUESSED THE LOCATION OF THE BROKEN NEEDLE AND RE-OPENING OF THE ABDOMEN WAS PERFORMED. SINCE THE NEEDLE REMAINED IN THE SUBCUTANEOUS AND NOT INTRAPERITONEAL, THE RE-OPERATION WAS LIMITED TO OPENING THE EPIDERMAL AND DERMAL LAYERS BY ABOUT 1 CM. THE OPERATION TIME WAS EXTENDED FOR MORE THAN 30 MINUTES. THE SURGEON OPINED THAT THIS EVENT MAY HAVE OCCURRED SINCE THE PATIENT HAD A THICK SUBCUTANEOUS LAYER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18208595 ↗
• MalfunctionJan 18, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13281489 ↗
• MalfunctionMay 7, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN CLOSURE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURE BROKE DURING CLOSURE OF BACK SKIN. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11793767 ↗
• InjuryMay 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CV PORT FIXATION PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE SUTURE WAS USED ON DERMAL LAYER FOR WOUND OF THE UPPER RIGHT ARM. A CATHETER WAS PLACED UNDER THE DERMIS. ON (B)(6) 2019 THE PATIENT EXPERIENCED FATIGUE, FEVER, PAIN AND REDDENING AT THE CV PORT SITE. ON (B)(6) 2019 THE PATIENT WAS EVALUATED AT THE HOSPITAL AND INCISION SITE WITH PUS ADHESION. THE SURGEON OPINED THAT THERE WAS POSSIBILITY OF CATHETER INFECTION. CHEST XRAY CONFIRMED THAT THE PORT SYSTEM WAS NOT DAMAGED. AN ADDITIONAL PROCEDURE WAS PERFORMED, AND THE SUTURE AND CATHETER WERE REMOVED FLUOROSCOPICALLY. DEBRIDEMENT WAS PERFORMED FOR THE REDDENING ON THE WOUND EDGE AND THE WOUND EDGE WAS CLOSED WITH A DIFFERENT SUTURE TYPE. THE PATIENT CONDITION IS REPORTED AS STABLE. THE SURGEON OPINED THAT THE INFECTION IS NOT CAUSED BY THE PRODUCT BUT IS CONSIDERED TO BE DUE TO THE PROCEDURE OR COMMUNICATION WITH THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Fatigue; Fever; Not Applicable; Pain; Unspecified Infection

  MAUDE report 8612193 ↗

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-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.