PDS Z259HRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031060340), received between Mar 11, 2025 and Jan 8, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Aug 10, 2023Open, Classified

   Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.

   Z-2617-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEY HAVE HAD 2 INSTANCES WHERE THESE SUTURES HAVE BEEN BREAKING OFF DURING SURGERY. IT SEEMS THAT APPROXIMATELY THE LAST 10 SUTURES IN THE PACK WERE VERY WEAK AND KEPT BREAKING. THIS HAPPENED WHILE DR. WAS SUTURING A PATIENT ON (B)(6) 2025 AND AGAIN ON (B)(6) 2025. THEY SAID THAT THERE WERE PROBABLY 7 TOTAL SUTURES OUT OF THAT BOX THAT BROKE WITH VERY LITTLE TENSION AND THEY COULDN'T BE USED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE AVAILABILITY WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004464 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEY HAVE HAD 2 INSTANCES WHERE THESE SUTURES HAVE BEEN BREAKING OFF DURING SURGERY. IT SEEMS THAT APPROXIMATELY THE LAST 10 SUTURES IN THE PACK WERE VERY WEAK AND KEPT BREAKING. THIS HAPPENED WHILE DR. WAS SUTURING A PATIENT ON (B)(6) 2025 AND AGAIN (B)(6) 2025. THEY SAID THAT THERE WERE PROBABLY 7 TOTAL SUTURES OUT OF THAT BOX THAT BROKE WITH VERY LITTLE TENSION AND THEY COULDN¿T BE USED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE AVAILABILITY WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004460 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEY HAVE HAD 2 INSTANCES WHERE THESE SUTURES HAVE BEEN BREAKING OFF DURING SURGERY. IT SEEMS THAT APPROXIMATELY THE LAST 10 SUTURES IN THE PACK WERE VERY WEAK AND KEPT BREAKING. THIS HAPPENED WHILE DR. WAS SUTURING A PATIENT ON (B)(6) 2025 AND AGAIN ON (B)(6) 2025. THEY SAID THAT THERE WERE PROBABLY 7 TOTAL SUTURES OUT OF THAT BOX THAT BROKE WITH VERY LITTLE TENSION AND THEY COULD NOT BE USED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE AVAILABILITY WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004388 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEY HAVE HAD 2 INSTANCES WHERE THESE SUTURES HAVE BEEN BREAKING OFF DURING SURGERY. IT SEEMS THAT APPROXIMATELY THE LAST 10 SUTURES IN THE PACK WERE VERY WEAK AND KEPT BREAKING. THIS HAPPENED WHILE DR. WAS SUTURING A PATIENT ON (B)(6) 2025 AND AGAIN (B)(6) 2025. THEY SAID THAT THERE WERE PROBABLY 7 TOTAL SUTURES OUT OF THAT BOX THAT BROKE WITH VERY LITTLE TENSION AND THEY COULDN'T BE USED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE AVAILABILITY WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004385 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEY HAVE HAD 2 INSTANCES WHERE THESE SUTURES HAVE BEEN BREAKING OFF DURING SURGERY. IT SEEMS THAT APPROXIMATELY THE LAST 10 SUTURES IN THE PACK WERE VERY WEAK AND KEPT BREAKING. THIS HAPPENED WHILE DR. WAS SUTURING A PATIENT ON (B)(6) 2025 AND AGAIN (B)(6) 2025. THEY SAID THAT THERE WERE PROBABLY 7 TOTAL SUTURES OUT OF THAT BOX THAT BROKE WITH VERY LITTLE TENSION AND THEY COULDN¿T BE USED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE AVAILABILITY WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004380 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEY HAVE HAD 2 INSTANCES WHERE THESE SUTURES HAVE BEEN BREAKING OFF DURING SURGERY. IT SEEMS THAT APPROXIMATELY THE LAST 10 SUTURES IN THE PACK WERE VERY WEAK AND KEPT BREAKING. THIS HAPPENED WHILE DR. WAS SUTURING A PATIENT ON (B)(6) 2025 AND AGAIN (B)(6) 2025. THEY SAID THAT THERE WERE PROBABLY 7 TOTAL SUTURES OUT OF THAT BOX THAT BROKE WITH VERY LITTLE TENSION AND THEY COULDN'T BE USED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE AVAILABILITY WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004379 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEY HAVE HAD 2 INSTANCES WHERE THESE SUTURES HAVE BEEN BREAKING OFF DURING SURGERY. IT SEEMS THAT APPROXIMATELY THE LAST 10 SUTURES IN THE PACK WERE VERY WEAK AND KEPT BREAKING. THIS HAPPENED WHILE DR. WAS SUTURING A PATIENT ON (B)(6) 2025 AND AGAIN (B)(6) 2025. THEY SAID THAT THERE WERE PROBABLY 7 TOTAL SUTURES OUT OF THAT BOX THAT BROKE WITH VERY LITTLE TENSION AND THEY COULDN¿T BE USED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE AVAILABILITY WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004378 ↗
• MalfunctionMar 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION ON (B)(6)2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE FROM THE SUTURE. THE STRING COMPLETELY BROKE OFF. THE CASE WAS EXTENDED BY TWENTY-FIVE MINUTES. THE NEEDLE WAS FOUND AND REMOVED FROM THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21572348 ↗