PDS Z452GRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031218703), received between Nov 15, 2018 and Jan 14, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2025Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THEY RECENTLY PURCHASED SUTURE. THE PRODUCT SEEMS TO BE FAULTY AS WHEN THE DOCTOR WAS PERFORMING SURGERY THE NEEDLE COMES OFF OF THE SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21153911 ↗
• MalfunctionJan 14, 2025Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THEY RECENTLY PURCHASED SUTURE. THE PRODUCT SEEMS TO BE FAULTY AS WHEN THE DOCTOR WAS PERFORMING SURGERY THE NEEDLE COMES OFF OF THE SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21153892 ↗
• MalfunctionJan 14, 2025Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THEY RECENTLY PURCHASED SUTURE. THE PRODUCT SEEMS TO BE FAULTY AS WHEN THE DOCTOR WAS PERFORMING SURGERY THE NEEDLE COMES OFF OF THE SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21153885 ↗
• MalfunctionMar 12, 2024Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT 3 NEEDLES COME LOOSE FROM SUTURE DURING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885399 ↗
• MalfunctionMar 12, 2024Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT 3 NEEDLES COME LOOSE FROM SUTURE DURING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885398 ↗
• MalfunctionMar 12, 2024Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT 3 NEEDLES COME LOOSE FROM SUTURE DURING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885394 ↗
• MalfunctionMar 22, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A BOX OF 12 SUTURES HAS 10 CORRECT PACKS OF SUTURE AND 2 INCORRECT PACKS INSIDE OF THE BOX. (ORDERED Z452G BOX 12. BOX HAS 10 PACKS OF Z452G AND 2 PACKS Z824G). THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16593119 ↗
• MalfunctionSep 13, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A FELINE UNDERWENT A SPAY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12465524 ↗
• MalfunctionJul 1, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CANINE OVARIOHYSTERECTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. POST-OPERATIVELY, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 12105130 ↗
• MalfunctionJul 1, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CANINE OVARIOHYSTERECTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. POST-OPERATIVELY, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 12105129 ↗
• MalfunctionJul 1, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CANINE OVARIOHYSTERECTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. POST-OPERATIVELY, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 12105128 ↗
• MalfunctionJul 1, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CANINE OVARIOHYSTERECTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. POST-OPERATIVELY, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 12105127 ↗
• MalfunctionJul 1, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CANINE OVARIOHYSTERECTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. POST-OPERATIVELY, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 12105126 ↗
• MalfunctionNov 10, 2020Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE TRYING TO TIE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10816784 ↗
• MalfunctionMar 25, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE KEPT BREAKING. UPON INSPECTING THE SUTURE LATER ON, SMALL WEAK SPOTS WERE NOTICED ALONG THE WHOLE LENGTH OF THE SUTURE. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9876354 ↗
• MalfunctionNov 28, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED A PATIENT UNDERWENT AND UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE PACKAGES PRODUCT CODE INSIDE OF BOX DO NOT MATCH PRODUCT CODE ON BOX. SUTURE PACKET LABELED AS Z332H (PDS II SUTURE) AND OUTSIDE OF BOX IS PRODUCT CODE Z452G (PDS II SUTURE). CUSTOMER DID OPEN ONE PACKAGE BEFORE NOTICING THE ERROR. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8112194 ↗
• MalfunctionNov 15, 2018Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CAT SPAYING PROCEDURE ON (B)(6) 2018 AND A SUTURE WAS USED. AFTER SURGERY, THE ANIMAL WAS X-RAYED AND FOUND THAT THE SUTURE HAD BROKEN IN THE MIDDLE. THE KNOTS WERE INTACT BUT THE MIDDLE OF THE SUTURE LINE WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8073936 ↗