PDS PDP334HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031048072), received between May 30, 2022 and Mar 13, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Break

  IT WAS REPORTED BY THE SALES REP THAT DURING THE HERNIA PROCEDURE, THREE DIFFERENT SUTURES ON THE SAME LOT WAS USED. THE FIRST ONE THE NEEDLE GOT BROKEN OFF. THEY USED TWO MORE SUTURES AND BOTH NEEDLES GOT BENT. THE NEEDLES WERE SUCCESSFULLY RETRIEVED FROM PATIENT'S BODY. DEVICES ARE RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597051 ↗
• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A ROBOTIC ASSISTED LAPAROSCOPIC EXPLORATORY SURGERY WITH BILATERAL SALPINGO-OOPHORECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. NEEDLE BROKE ON SUTURES CODES DURING THE PROCEDURE. NEEDLE WAS RECOVERED. NO X-RAY NEEDED TO RECOVER THE NEEDLE. ANOTHER LIKE DEVICE OF SUTURE CODE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21584305 ↗
• MalfunctionSep 17, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP CHOLE ON (B)(6) 2024 AND SUTURE WAS USED. THE SURGEON WAS CLOSING HIS UMBILICAL PORT SITE. UPON HIS FIRST PASS OF THE SUTURE, THE NEEDLE BROKE OFF JUST BELOW THE SWAGE. THE BODY OF THE NEEDLE ENTERED THE INCISION AND WAS UNABLE TO BE IMMEDIATELY LOCATED. SURGEON HAD TO ELONGATE HIS INCISIONAL SITE, AND CALL FOR X-RAY TO LOCATE THE REMAINING NEEDLE PORTION BEFORE BEING FOUND. THE PROCEDURE WAS DELAYED BY 30 MINUTES AND NO KNOWN POSTOPERATIVE COMPLICATIONS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20236657 ↗
• MalfunctionNov 9, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FASCIAL CLOSURE PROCEDURE IN 2023 AND SUTURE WAS USED. DURING FASCIAL CLOSURE, TWO SUTURES HAD ALREADY TORN FOR NO APPARENT REASON; WITH ANOTHER ONE, THE SURGERY HAD BEEN CONTINUED AND COMPLETED AS PLANNED. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103813 ↗
• MalfunctionNov 9, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FASCIAL CLOSURE PROCEDURE IN 2023 AND SUTURE WAS USED. DURING FASCIAL CLOSURE, TWO SUTURES HAD ALREADY TORN FOR NO APPARENT REASON; WITH ANOTHER ONE, THE SURGERY HAD BEEN CONTINUED AND COMPLETED AS PLANNED. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103809 ↗
• MalfunctionAug 8, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE SUTURE BROKE IN A PATIENT INTRA-OP, DURING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484923 ↗
• MalfunctionFeb 9, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, TWO BATCHES OF PDS WHICH HAVE BEEN USED IN ABDOMINAL SURGERIES AND 3 OF THE PATIENTS HAVE RETURNED WITH HERNIATION DUE TO THE MUSCLE LAYER SUTURE SNAPPING AND NEEDED FOLLOW UP REPAIR SURGERY. WE HAVE REMOVED THESE TWO BATCHES FROM OUR STOCK AND HAVE SINCE NOT ENCOUNTERED ANY FURTHER ISSUES. TESTING THE SUTURE IT DOES SNAP WITH MINIMAL FORCE SO I WOULD ASSUME THERE IS A PROBLEM WITH IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia

  MAUDE report 16344951 ↗
• MalfunctionFeb 9, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, TWO BATCHES OF PDS WHICH HAVE BEEN USED IN ABDOMINAL SURGERIES AND 3 OF THE PATIENTS HAVE RETURNED WITH HERNIATION DUE TO THE MUSCLE LAYER SUTURE SNAPPING AND NEEDED FOLLOW UP REPAIR SURGERY. WE HAVE REMOVED THESE TWO BATCHES FROM OUR STOCK AND HAVE SINCE NOT ENCOUNTERED ANY FURTHER ISSUES. TESTING THE SUTURE IT DOES SNAP WITH MINIMAL FORCE SO I WOULD ASSUME THERE IS A PROBLEM WITH IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia

  MAUDE report 16344948 ↗
• MalfunctionFeb 9, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, TWO BATCHES OF PDS WHICH HAVE BEEN USED IN ABDOMINAL SURGERIES AND 3 OF THE PATIENTS HAVE RETURNED WITH HERNIATION DUE TO THE MUSCLE LAYER SUTURE SNAPPING AND NEEDED FOLLOW UP REPAIR SURGERY. WE HAVE REMOVED THESE TWO BATCHES FROM OUR STOCK AND HAVE SINCE NOT ENCOUNTERED ANY FURTHER ISSUES. TESTING THE SUTURE IT DOES SNAP WITH MINIMAL FORCE SO I WOULD ASSUME THERE IS A PROBLEM WITH IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia

  MAUDE report 16344947 ↗
• MalfunctionMay 30, 2022Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14545280 ↗
• MalfunctionMay 30, 2022Material Separation; Material Separation

  THE SURGEON HAS REPORTED THAT A PDS SUTURE HAD FOR A 2ND TIME IN TWO WEEKS COME OFF THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14545276 ↗

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-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-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.