PDS Z320HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031060517), received between Mar 13, 2019 and Aug 31, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 10, 2024Open, Classified

   Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

   Z-2146-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50519794 ↗
• MalfunctionFeb 7, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE WHEN PASSING THE STITCH AND TRYING TO TIE THE SUTURE, THE THREAD BREAKS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315418 ↗
• MalfunctionFeb 2, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SEPTOPLASTY PROCEDURE ON 1/25/2023 AND SUTURE WAS USED. WHEN PASSING THE STITCH AND TRYING TO TIE THE SUTURE, THE THREAD BREAKS. THE NEEDLE AND THREAD WERE REMOVED AND REMOVED FROM THE SURGICAL TABLE AND A NEW SUTURE WAS REQUESTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16283462 ↗
• MalfunctionMar 13, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NASAL SEPTAL RECONSTRUCTION PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. AT THE MOMENT OF RECEIVING THE SUTURE, THE NEEDLE SEPARATED FROM THE THREAD. A SECOND LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8418450 ↗