PDS Z711DRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031061590), received between Sep 13, 2019 and Dec 19, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

3 other recalls cover devices cleared under the same FDA submission (K183183); 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.

• MalfunctionDec 19, 2023Material Separation; Material Separation

  IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, IT WAS VERY HARD TO DETACH THE NEEDLE FROM THE SUTURE. IT WAS A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. AFFILIATE REFERENCE NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18354965 ↗
• MalfunctionOct 28, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 10/19/2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10748649 ↗
• MalfunctionOct 28, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10748614 ↗
• MalfunctionSep 24, 2019Break; Tear, Rip or Hole in Device Packaging; Break; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PANCREATICODUODENECTOMY ON (B)(6) 2019 AND SUTURE WAS USED. DURING INTERRUPTED SUTURING ON THE DIGESTIVE TRACT, THE SUTURE WAS BROKEN WHEN TYING A KNOT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9109781 ↗
• MalfunctionSep 13, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. DURING USE, THE SUTURE WAS BROKEN. ANOTHER LIKE SUTURE WAS USED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9038937 ↗
• MalfunctionSep 13, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. DURING USE, THE SUTURE WAS BROKEN. ANOTHER LIKE SUTURE WAS USED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9038791 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183183. One submission often covers many models, so check the product and lot details in each record.

• Z-1513-2025 · Mar 7, 2025 · Open, Classified
  PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
• Z-0319-2025 · Sep 25, 2024 · Open, Classified
  Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
• Z-2146-2024 · May 10, 2024 · Open, Classified
  PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery.