PDS Z332HRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031060524), received between Jan 30, 2019 and Jan 17, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAYING & NEUTERING PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE CUSTOMER THAT DURING A SPAYING PROCEDURE THE SUTURES CONTINUED TO RIP EVEN WITH A GENTLE TUG. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183787 ↗
• MalfunctionJan 17, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A VETERINARY PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE CUSTOMER THAT DURING A PYOMETRA PROCEDURE THE SUTURES CONTINUED TO RIP EVEN WITH A GENTLE TUG. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183779 ↗
• MalfunctionJan 17, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A VETERINARY PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE CUSTOMER THAT DURING A PYOMETRA PROCEDURE THE SUTURES CONTINUED TO RIP EVEN WITH A GENTLE TUG. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183778 ↗
• MalfunctionMar 12, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT HAPPENED WITH ABOUT THREE TO FOUR PACKETS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11473816 ↗
• MalfunctionMar 12, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT HAPPENED WITH ABOUT THREE TO FOUR PACKETS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11473803 ↗
• MalfunctionJan 30, 2019Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE FINISHING AND TYING THE KNOT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8290042 ↗
• MalfunctionJan 30, 2019Break; Break

  IT WAS REPORTED THAT A ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE FINISHING AND TYING THE KNOT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8290037 ↗