PDS Z452HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031061026), received between Mar 31, 2020 and Apr 6, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2023Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING PROCEDURE, THE SUTURE BREAKS, AND THE DAY AFTER SURGERY THERE HAS ALSO BEEN A STITCH REACTION ON THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16689181 ↗
• MalfunctionApr 6, 2023Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING PROCEDURE, THE SUTURE BREAKS, AND THE DAY AFTER SURGERY THERE HAS ALSO BEEN A STITCH REACTION ON THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16689137 ↗
• MalfunctionMar 31, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A DOG UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE VETERINARIAN WAS PRICKING WITH THE NEEDLE, THE NEEDLE DETACHED FROM THE THREAD AND WITHOUT EXERTING EXCESSIVE TENSION TO THE THREAD. NO CONSEQUENCES TO THE DOG. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9903094 ↗