PDS Z968HRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031061934), received between Sep 3, 2019 and Oct 15, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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

• MalfunctionOct 15, 2024Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE HAD FALLEN APART AND THE ANIMAL EXPERIENCED A WOUND DEHISCENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 20452629 ↗
• MalfunctionJun 6, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE GOT DISCONNECTED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14606146 ↗
• MalfunctionMar 24, 2020Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAY PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR WAS SUTURING TISSUE AND THE SUTURE WAS CORK SCREWING AND BREAKING IN THE MIDDLE OF THE STRAND, UNKNOWN TISSUE LAYER, UNKNOWN LOOP. ANOTHER LIKE DEVICE WAS USED. NO CONSEQUENCES TO THE ANIMAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9871720 ↗
• MalfunctionMar 24, 2020Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAY PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR WAS SUTURING TISSUE AND THE SUTURE WAS CORK SCREWING AND BREAKING IN THE MIDDLE OF THE STRAND, UNKNOWN TISSUE LAYER, UNKNOWN LOOP. ANOTHER LIKE DEVICE WAS USED. NO CONSEQUENCES TO THE ANIMAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9871719 ↗
• MalfunctionMar 24, 2020Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAY PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR WAS SUTURING TISSUE AND THE SUTURE WAS CORK SCREWING AND BREAKING IN THE MIDDLE OF THE STRAND, UNKNOWN TISSUE LAYER, UNKNOWN LOOP. ANOTHER LIKE DEVICE WAS USED. NO CONSEQUENCES TO THE ANIMAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9871713 ↗
• MalfunctionSep 4, 2019Material Separation; Material Separation

  IT WAS REPORTED BY A VETERINARIAN THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS SEPARATING FROM THE NEEDLE WHILE SUTURING TISSUE, UNKNOWN LAYER, INTERRUPTED LOOP. ADDITIONAL SUTURE FROM THE SAME BOX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8962237 ↗
• MalfunctionSep 4, 2019Material Separation; Material Separation

  IT WAS REPORTED BY A VETERINARIAN THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS SEPARATING FROM THE NEEDLE WHILE SUTURING TISSUE, UNKNOWN LAYER, INTERRUPTED LOOP. ADDITIONAL SUTURE FROM THE SAME BOX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8962234 ↗
• MalfunctionSep 3, 2019Material Separation; Material Separation

  IT WAS REPORTED BY A VETERINARIAN THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS SEPARATING FROM THE NEEDLE WHILE SUTURING TISSUE, UNKNOWN LAYER, INTERRUPTED LOOP. ADDITIONAL SUTURE FROM THE SAME BOX WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8958097 ↗