PDS Z467HRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031061071), received between Dec 20, 2019 and Feb 24, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, WHEN THEY OPENED THE PACK FOR THE FIRST 2 PACKS THE NEEDLE FELL OFF THE SUTURE. PER CUSTOMER THIS ONLY INVOLVED ONE SURGERY. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT IT WAS RECEIVED ONE NEEDLE AND SUTURE THAT PERTAINED TO PRODUCT CODE Z467H. AFTER INVESTIGATION OF THE SAMPLE, SHORT INSERTION WAS OBSERVED IN THE STRAND. THE VISUAL INSPECTION CONCLUDED THAT THE COMBINATION OF THE NEEDLE/SUTURE WAS DETACHED FROM THE NEEDLE SINCE THE INSERTION END OF THE SUTURE DID NOT MEET THE REQUIREMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18774759 ↗
• MalfunctionFeb 23, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY FOUND THAT THE SUTURE SEEMS TO BE GETTING CAUGHT WITHIN THE PLASTIC CASING AND THEY HAVE TO REALLY PULL HARD OR BREAK OPEN THE CASING TO GET THE SUTURE OUT. THEY DON'T HAVE ANY SAMPLES TO SUBMIT AS THEY ENDED UP USING THE SUTURE IN SURGERY AND DISPOSED OF THEM AFTER. THEY ALSO FOUND THAT IN 2 PACKAGES THE SUTURE BROKE EASILY WITHOUT MUCH FORCE DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18769315 ↗
• MalfunctionFeb 23, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY FOUND THAT THE SUTURE SEEMS TO BE GETTING CAUGHT WITHIN THE PLASTIC CASING AND THEY HAVE TO REALLY PULL HARD OR BREAK OPEN THE CASING TO GET THE SUTURE OUT. THEY DON'T HAVE ANY SAMPLES TO SUBMIT AS THEY ENDED UP USING THE SUTURE IN SURGERY AND DISPOSED OF THEM AFTER. THEY ALSO FOUND THAT IN 2 PACKAGES THE SUTURE BROKE EASILY WITHOUT MUCH FORCE DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18769313 ↗
• MalfunctionApr 7, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN NEUTER AND STOMACH TACK ON JANUARY 3, 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE AT THE NEEDLE, THE SUTURE UNSWEDGED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047303 ↗
• MalfunctionApr 7, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN NEUTER AND STOMACH TACK ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE AT THE NEEDLE, THE SUTURE UNSWEDGED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047299 ↗
• MalfunctionJan 4, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A BULLDOG UNDERWENT A CANINE C-SECTION PROCEDURE IN 2020 AND THE SUTURE WAS USED. AFTER THE SURGERY, THE SUTURE GOT LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11108047 ↗
• MalfunctionDec 20, 2019Break; Break

  IT WAS REPORTED THAT THE ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND SUTURE WAS USED. THE ANIMAL EXPERIENCED WOUND DEHISCENCE WITHIN 3 DAYS AFTER PROCEDURE. POST OPERATIVELY, THE SUTURE BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9506284 ↗
• MalfunctionDec 20, 2019Break; Break

  IT WAS REPORTED THAT THE ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND SUTURE WAS USED. THE ANIMAL EXPERIENCED WOUND DEHISCENCE WITHIN 3 DAYS AFTER PROCEDURE. POST OPERATIVELY, THE SUTURE BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9506267 ↗
• MalfunctionDec 20, 2019Break; Break

  IT WAS REPORTED THAT THE ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND SUTURE WAS USED. THE ANIMAL EXPERIENCED WOUND DEHISCENCE WITHIN 3 DAYS AFTER PROCEDURE. POST OPERATIVELY, THE SUTURE BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9506262 ↗
• MalfunctionDec 20, 2019Break; Break

  IT WAS REPORTED THAT THE ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND SUTURE WAS USED. THE ANIMAL EXPERIENCED WOUND DEHISCENCE WITHIN 3 DAYS AFTER PROCEDURE. POST OPERATIVELY, THE SUTURE BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9506245 ↗