PDS Z466HRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705031061057), received between Dec 3, 2018 and Mar 11, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT ONE OF THEIR ACCOUNTS HAS HAD 3 OR 4 SUTURE FAILURES FROM SUTURE. THE PRODUCT WAS PURCHASED IN (B)(6) 2025. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569083 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT ONE OF THEIR ACCOUNTS HAS HAD 3 OR 4 SUTURE FAILURES FROM SUTURE. THE PRODUCT WAS PURCHASED IN DECEMBER 2025. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569076 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT ONE OF THEIR ACCOUNTS HAS HAD 3 OR 4 SUTURE FAILURES FROM SUTURE. THE PRODUCT WAS PURCHASED IN (B)(6) 2025. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569075 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT ONE OF THEIR ACCOUNTS HAS HAD 3 OR 4 SUTURE FAILURES FROM SUTURE. THE PRODUCT WAS PURCHASED IN (B)(6) 2025. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569072 ↗
• MalfunctionAug 20, 2024Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE ISSUE IS THAT THE SUTURE KEEPS BREAKING WITH ANY TENSION, DURING USE. VET OPENED 2 PACKS BACK TO BACK WITH THE SAME PATIENT DURING SURGERY. THE SECOND PACK OF SUTURES THAT THE VET TRIED BROKE 3 TIMES BEFORE GIVING UP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20006412 ↗
• MalfunctionAug 19, 2024Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE ISSUE IS THAT THE SUTURE KEEPS BREAKING WITH ANY TENSION, DURING USE. VET OPENED 2 PACKS BACK TO BACK WITH THE SAME PATIENT DURING SURGERY. THE SECOND PACK OF SUTURES THAT THE VET TRIED BROKE 3 TIMES BEFORE GIVING UP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19999417 ↗
• MalfunctionDec 7, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNSPECIFIED PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THE DOCTOR WAS USING THE SUTURE, HE WENT TO TIE THE STITCH AND THE SUTURE RIPPED. HE TRIED PULLING IT AND PIECES OF THE SUTURE WOULD COME OFF. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15932974 ↗
• MalfunctionSep 7, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15369712 ↗
• MalfunctionJan 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE AND IT WAS NOTED THAT THE SUTURE DID NOT HAVE THE SAME TENSILE STRENGTH IT NORMALLY DOES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13284562 ↗
• MalfunctionJan 5, 2022Break; 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 WHILE TYING KNOTS WITH MINIMAL TENSION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13173137 ↗
• MalfunctionDec 14, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BROKE WITH MINIMAL TENSION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13001923 ↗
• MalfunctionApr 2, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. PRIOR TO USE, IT WAS NOTED THAT THE OUTER PACKAGING IS Z466H, BUT INNER PACKAGING IS Z358T. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611214 ↗
• MalfunctionJan 22, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON (B)(6) 2020 DATE AND SUTURE WAS USED. THE SUTURE BROKE POST-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11214449 ↗
• MalfunctionJan 22, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON (B)(6) 2020 DATE AND SUTURE WAS USED. THE SUTURE BROKE INTRA-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11214444 ↗
• MalfunctionJan 22, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON DATE (B)(6) 2020, AND SUTURE WAS USED. THE SUTURE BROKE POST-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11214359 ↗
• MalfunctionJan 22, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON (B)(6) 2020 DATE AND SUTURE WAS USED. THE SUTURE BROKE POST-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11214358 ↗
• MalfunctionDec 3, 2018Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED PARTWAY DOWN THE LENGTH DURING NORMAL USE. THERE WERE NO ADVERSE CONSEQUENCES. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8125600 ↗
• MalfunctionDec 3, 2018Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED PARTWAY DOWN THE LENGTH DURING NORMAL USE. THERE WERE NO ADVERSE CONSEQUENCES. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8125592 ↗
• MalfunctionDec 3, 2018Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED PARTWAY DOWN THE LENGTH DURING NORMAL USE. THERE WERE NO ADVERSE CONSEQUENCES. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8125591 ↗