PDS PDP513GRecalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10705031048485), received between Apr 10, 2018 and Apr 30, 2026 — classified as 1 injury, 42 malfunctions.

The most frequently reported specific device problem is “Break” (36 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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN DURING THE SECOND LIGATION OF THE DERMAL SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046269 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE, AND IT OCCURRED 2 TIMES IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT 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 24475303 ↗
• MalfunctionFeb 27, 2026Break

  AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE, AND IT OCCURRED 2 TIMES IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT 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 24475289 ↗
• MalfunctionJun 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213852 ↗
• MalfunctionNov 11, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE DOCTOR FELT THE NEEDLE TIP WAS NOT SHARP ENOUGH DURING SUTURING. WHEN THE NEEDLE WAS REMOVED, IT WAS FOUND THAT THE NEEDLE TIP WAS MISSING AND GONE. A VISUAL SEARCH WAS CONDUCTED, BUT THE NEEDLE TIP WAS NOT FOUND, SO X-RAYS WERE TAKEN. AS A RESULT, THE NEEDLE TIP WAS SUCCESSFULLY FOUND ON THE DRAPE OUTSIDE OF THE PATIENT¿S BODY. IT WAS NOT A CONTROL RELEASE NEEDLE. THE PRODUCT WAS USED ON SUBCUTANEOUS DERMIS. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20655038 ↗
• MalfunctionSep 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING USE IN AN UNKNOWN OB-GYN SURGERY, THE NEEDLE AND SUTURE DETACHED EASILY WHEN TENSION WAS APPLIED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279001 ↗
• MalfunctionFeb 20, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18744151 ↗
• MalfunctionJan 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18579309 ↗
• MalfunctionAug 8, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND A SUTURE WAS USED. DURING SURGERY, WHEN THE NEEDLE-SUTURE WAS PASSING THROUGH THE SKIN, THE SUTURE WAS BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484954 ↗
• MalfunctionJul 1, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE DURING INTERRUPTED SUTURING ON THE DERMIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14885676 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN PAPILLECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING SUTURING. NO FRAGMENT WAS LEFT IN THE PATIENT¿S BODY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13861433 ↗
• MalfunctionMar 14, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE LOOKED BENT. UPON THE VALUATION OF THE RETURNED SAMPLE, A FRACTURE WAS OBSERVED AT THE TIP OF THE NEEDLE. ONE SIDE OF THE NEEDLE WAS RECEIVED, THE MATING FRACTURE SURFACE WAS NOT PROVIDED FOR THIS EVALUATION. A SCANNING ELECTRON MICROSCOPE WAS USED TO EXAMINE THE FRACTURE SURFACES AND SURROUNDING AREA OF THE NEEDLE. THE FRACTURE SURFACES WERE EXAMINED IN MULTIPLE LOCATIONS TO DETERMINE THE FRACTURE MODE. THE EVALUATION OF (B)(4) REVEALED THE FRACTURE WAS COMPOSED OF MICROVOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE FRACTURE MODE. THIS WAS A DUCTILE FRACTURE. THE EVIDENCE OF THIS EXAMINATION INDICATES THAT THE BREAKAGE OCCURRED AT THE TIP OF THE NEEDLE DURING USE DUE TO TENSILE OVERLOAD. THERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13764587 ↗
• MalfunctionMar 12, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE TIP BROKE, ON (B)(6) 2022 ADDITIONAL INFORMATION RECEIVED CONFIRMING THAT THE NEEDLE DID NOT BROKE. UPON EVALUATION OF THE RETURNED SAMPLE, A FRACTURE WAS OBSERVED AT THE TIP OF THE NEEDLE. ONE SIDE OF THE NEEDLE WAS RECEIVED, THE MATING FRACTURE SURFACE WAS NOT PROVIDED FOR THIS EVALUATION. A SCANNING ELECTRON MICROSCOPE WAS USED TO EXAMINE THE FRACTURE SURFACES AND SURROUNDING AREA OF THE NEEDLE. THE FRACTURE SURFACES WERE EXAMINED IN MULTIPLE LOCATIONS TO DETERMINE THE FRACTURE MODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13743785 ↗
• MalfunctionJan 14, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING INTERRUPTED SUTURING. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13257809 ↗
• MalfunctionJan 14, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING INTERRUPTED SUTURING. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13257805 ↗
• MalfunctionJan 4, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING PROCEDURE THE NURSE SET THE NEEDLE IN THE NEEDLE HOLDER AND LEFT IT THERE, BUT WHEN TRYING TO USE IT, THE TIP OF THE NEEDLE HAD BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13161015 ↗
• MalfunctionSep 21, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE 3 CM FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12508427 ↗
• MalfunctionSep 3, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS REPORTED THAT SUTURE BREAKAGE OCCURRED DURING CONTINUOUS SUTURING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422990 ↗
• MalfunctionAug 3, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268455 ↗
• MalfunctionAug 3, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268447 ↗
• MalfunctionAug 3, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268430 ↗
• MalfunctionJun 24, 2021Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER STARTING THE DERMAL SUTURE, THE SUTURE BROKE AROUND THE SWAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12057605 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON UNKNOWN DATE AND THE SUTURE WAS USED. AFTER SURGERY, THE PATIENT EXPERIENCED PAINFUL INFLAMMATION. IT WAS REPORTED THAT LOCAL NEGATIVE PRESSURE THERAPY, VAC THERAPY, OR PICO THERAPY CANNOT BE APPLIED ANYWHERE, BECAUSE WHEN ABDOMINAL SUTURE WAS PERFORMED THERE WAS AN INFLAMMATORY REACTION WITH SEVERE PAIN AFTER SURGERY. MRI ALSO CONFIRMED INFLAMMATION. THE PATIENT IS STILL HOSPITALIZED AT THE DEPARTMENT OF PLASTIC SURGERY. THE PATIENT IS SUSPECTED TO HAVE INTRACTABLE DISEASE. THE POSSIBILITY OF INTRACTABLE DISEASE IS HIGH AND CURRENTLY THE PATIENT VISITED VARIOUS MEDICAL DEPARTMENTS FOR EXAMINATIONS. AT PRESENT, THE PATIENT IS BEING TREATED AT THE PLASTIC SURGERY DEPARTMENT BUT THE CAUSE IS ALSO UNKNOWN AT THE THORACIC SURGERY DEPARTMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Inflammation; Pain

  MAUDE report 11941208 ↗
• MalfunctionApr 23, 2021Break; Break

  IT WAS REPORTED BY A SALES REP THAT, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, WHEN CLOSING THE SURGICAL WOUND, THE NEEDLE WAS BROKEN AT THE SWAGE PART. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. AFFILIATE REFERENCE NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11718683 ↗
• MalfunctionMar 25, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2021 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BREAKAGE OCCURRED DURING SKIN CLOSURE. THERE WERE NO PATIENT CONSEQUENCES. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11573019 ↗

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.