PDS Z695HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031061576), received between Feb 18, 2025 and Feb 18, 2025 — classified as 4 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, LATELY WITH THE LAST BATCH THEY HAVE BEEN SEEING A BREAK DOWN/DEHISCENCE OF THE SURGICAL SITE. THEY HAVE SEEN FOUR BREAKDOWNS OVER THE PAST TWO WEEKS. ALL FOUR PATIENTS HAVE BEEN SURGICALLY REPAIRED AND ARE DOING WELL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21407150 ↗
• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, LATELY WITH THE LAST BATCH THEY HAVE BEEN SEEING A BREAK DOWN/DEHISCENCE OF THE SURGICAL SITE. THEY HAVE SEEN FOUR BREAKDOWNS OVER THE PAST TWO WEEKS. ALL FOUR PATIENTS HAVE BEEN SURGICALLY REPAIRED AND ARE DOING WELL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21407143 ↗
• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, LATELY WITH THE LAST BATCH THEY HAVE BEEN SEEING A BREAK DOWN/DEHISCENCE OF THE SURGICAL SITE. THEY HAVE SEEN FOUR BREAKDOWNS OVER THE PAST TWO WEEKS. ALL FOUR PATIENTS HAVE BEEN SURGICALLY REPAIRED AND ARE DOING WELL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21407035 ↗
• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN JANUARY 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, LATELY WITH THE LAST BATCH THEY HAVE BEEN SEEING A BREAK DOWN/DEHISCENCE OF THE SURGICAL SITE. THEY HAVE SEEN FOUR BREAKDOWNS OVER THE PAST TWO WEEKS. ALL FOUR PATIENTS HAVE BEEN SURGICALLY REPAIRED AND ARE DOING WELL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21406160 ↗