PDS PDP6659HRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705031207387), received between Jul 12, 2019 and Sep 24, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (18 reports).

9 other recalls cover devices cleared under the same FDA submission (K061037); 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break

  It was reported that a patient underwent a Laparoscopic Appendectomy procedure on (b)(6)2026 and suture was used. It was reported by a sales rep that, during a laparoscopic Appendectomy, the suture was broken during the 1st ligation. It was not a control release needle. Another product was used to complete the case. No sample will be returned. There were no adverse consequences to the patient. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886657 ↗
• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SUTURE WAS BROKEN DURING LIGATION. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. 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 25136673 ↗
• MalfunctionMar 20, 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 OF PDP6659 FROM ICKIT36 WAS REPEATEDLY BROKEN DURING THE FIRST KNOT. 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 24651884 ↗
• MalfunctionMar 20, 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 OF PDP6659 FROM ICKIT36 WAS REPEATEDLY BROKEN DURING THE FIRST KNOT. 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 24651867 ↗
• MalfunctionMar 20, 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 OF PDP6659 FROM ICKIT36 WAS REPEATEDLY BROKEN DURING THE FIRST KNOT. 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 24651848 ↗
• MalfunctionMar 20, 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 OF PDP6659 FROM ICKIT36 WAS REPEATEDLY BROKEN DURING THE FIRST KNOT. 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 24651829 ↗
• MalfunctionMar 20, 2026Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE A SUTURE WAS USED. THE SUTURE WAS BROKEN DURING THE FIRST LIGATION. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24648130 ↗
• MalfunctionMar 20, 2026Break

  T WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE SUTURE WAS USED. THE SUTURE WAS BROKEN DURING THE FIRST LIGATION. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647963 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CHOLECYSTECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING SEMI-OPEN LAPAROSCOPIC CHOLECYSTECTOMY, THE SUTURE OF PDP6659H FROM ICKIT36 WAS OFTEN BROKEN DURING TYING. ALTHOUGH THE HOSPITAL TIED IT CARING OF FRICTION AND TWIST BUT IT WAS EASY TO BREAK. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570511 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CHOLECYSTECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING SEMI-OPEN LAPAROSCOPIC CHOLECYSTECTOMY, THE SUTURE OF PDP6659H FROM ICKIT36 WAS OFTEN BROKEN DURING TYING. ALTHOUGH THE HOSPITAL TIED IT CARING OF FRICTION AND TWIST BUT IT WAS EASY TO BREAK. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570510 ↗
• MalfunctionJun 25, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A HERNIA SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS BROKEN AT THE MOMENT OF GRASPING WITH A NEEDLE HOLDER. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19605289 ↗
• MalfunctionAug 14, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC LIVER RESECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE SWAGE PART DURING INTERRUPTED SUTURE ON FASCIA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17546510 ↗
• MalfunctionApr 26, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY ON (B)(6) 2023 AND SUTURE WAS USED. DURING USE ON THE PATIENT IT WAS NOTED THAT THE NEEDLE BROKE. THE NEEDLE WAS BROKEN AT THE MIDDLE PART DURING USE ON FASCIA. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815546 ↗
• MalfunctionApr 22, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN LAPAROSCOPIC PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE WAS BROKEN AT THE MIDDLE PART WHEN PASSING THE NEEDLE THROUGH. THE NEEDLE TIP WAS FOUND, AND THERE WAS NO EFFECT ON THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189312 ↗
• MalfunctionDec 30, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 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 13118639 ↗
• MalfunctionNov 24, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE SWAGE PART. THERE WAS NO EFFECT ON THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869192 ↗
• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP BROKE. X-RAY WAS TAKEN, AND THERE WAS NO PROBLEM WITH THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863253 ↗
• MalfunctionJul 12, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ENDOSCOPY ON (B)(6) 2019 AND SUTURE WAS USED FOR ABDOMINAL FASCIA ON THE TROCAR PORT INSERTION HOLE. THE NEEDLE WAS BROKEN AT THE BODY PART DURING CLOSING THE WOUND OF THE TROCAR. THE BROKEN NEEDLE WAS DROPPED IN THE BODY CAVITY, SO X-RAY WAS TAKEN, AND IT WAS FOUND ON THE SUBCUTIS, THEN THE BROKEN NEEDLE WAS RETRIEVED. THERE IS NO OPINION ON THE CAUSE OF THE BROKEN NEEDLE. THE PATIENT WAS DISCHARGED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8785089 ↗
• MalfunctionJul 12, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ENDOSCOPY ON (B)(6) 2019 AND SUTURE WAS USED FOR ABDOMINAL FASCIA ON THE TROCAR PORT INSERTION HOLE. THE NEEDLE WAS BROKEN AT THE BODY PART DURING CLOSING THE WOUND OF THE TROCAR. THE NEEDLE BREAK HAS NOT FALLEN INTO THE BODY. THERE IS NO OPINION ON THE CAUSE OF THE BROKEN NEEDLE. THE PATIENT WAS DISCHARGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8785085 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061037. 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.