PDS Z316HRecalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 10705031060470), received between Feb 13, 2018 and Jun 24, 2026 — classified as 91 malfunctions.

The most frequently reported specific device problem is “Break” (46 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 25 most recent of 91 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2026Break

  IT WAS REPORTED THAT A CAT UNDERWENT A STERILIZATION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE BREAKAGE AND TISSUE SEPARATION OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Wound Dehiscence

  MAUDE report 25607715 ↗
• MalfunctionJun 24, 2026Break

  IT WAS REPORTED THAT A CAT UNDERWENT A STERILIZATION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE BREAKAGE AND TISSUE SEPARATION OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Wound Dehiscence

  MAUDE report 25607714 ↗
• MalfunctionJun 24, 2026Break

  IT WAS REPORTED THAT A CAT UNDERWENT A STERILIZATION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE BREAKAGE AND TISSUE SEPARATION OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Wound Dehiscence

  MAUDE report 25607713 ↗
• MalfunctionJun 24, 2026Break

  IT WAS REPORTED THAT A CAT UNDERWENT A STERILIZATION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE BREAKAGE AND TISSUE SEPARATION OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Wound Dehiscence

  MAUDE report 25607709 ↗
• MalfunctionJun 24, 2026Break

  IT WAS REPORTED THAT A CAT UNDERWENT A STERILIZATION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE BREAKAGE AND TISSUE SEPARATION OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Wound Dehiscence

  MAUDE report 25607707 ↗
• MalfunctionJun 24, 2026Break

  IT WAS REPORTED THAT A CAT UNDERWENT A STERILIZATION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE BREAKAGE AND TISSUE SEPARATION OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Wound Dehiscence

  MAUDE report 25607682 ↗
• MalfunctionMar 19, 2026Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING A CAESAREAN SECTION (C-SECTION), ONE PACKAGE OF VCPB977H IN ICKIT HAD A KNOT ON THE SUTURE. AND AFTER OPENING THE PACKAGE OF Z316H, THE NEEDLE AND THREAD HAD ALREADY DETACHED, SO THE CUSTOMER STOPPED USING THESE TWO PRODUCTS AND TOOK OUT A NEW SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. NO SAMPLE WILL BE RETURNED. LOT NUMBER - F000102563 (PRODUCT CODE: VCPB977H) - UNKNOWN IF THIS IS THE CORRECT LOT NUMBER. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641838 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE, THE NEEDLE-SUTURE WAS DETACHED WHEN IT WAS PULLED. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843963 ↗
• MalfunctionNov 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURE AFTER MASTECTOMY THE NEEDLE CAME OF FROM THE THREAD, THEY TOOK ANOTHER ONE AND CONTINUED THE CLOSURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597838 ↗
• MalfunctionDec 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY WHEN THE DOCTOR WAS HOLDING THE NEEDLE AND TRYING TO GET THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20923944 ↗
• MalfunctionDec 6, 2024Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNSPECIFIED PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE FIRST SX WERE DONE AT AN ANIMAL HOSPITAL FOR JEJUNAL ENTEROTOMY, THE DVM IS NOT KNOWN, THE ORIGINAL SURGERY USED 4-0 SUTURE IN A SIMPLE CONTINUOUS PATTERN WITH AN ADDITIONAL SINGLE STITCH ELSEWHERE ON THAT SAME INCISION LINE AT LEAK CHECKED FINE. THE PET WAS SEEN AT AN EMERGENCY ROOM AND 3-0 SUTURE WAS USED FOR R&A REVISITATION SURGERY. THIS THEN DEHISCED AND THE PET WAS EUTHANIZED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Wound Dehiscence

  MAUDE report 20867182 ↗
• MalfunctionDec 4, 2024Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT " THIS REPORT IS BASED ON THE MIR SUBMITTED BY THE CUSTOMER: "DOCTOR HAD A CONCERN ABOUT THE 3-0 PDS VIOLET MONOFILAMENT (TAPER) SUTURE. THE SUTURE ITSELF DOESN'T SEEM AS STRONG AS IT NORMALLY IS. WHEN PULLED AT, IT SEEMS TO SNAP OFF. WHAT DO YOU THINK WOULD BE THE CAUSE OF THIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846207 ↗
• MalfunctionNov 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A AN ANIMAL UNDERWENT AN UNKNOWN ABDOMINAL CLOSURE VETERINARY PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER CUSTOMER THAT SUTURE KEEPS COMING OFF THE NEEDLE MIDWAY THROUGH SURGERY. THIS HAS HAPPENED SIX TIMES TO THE 3-0 SERIES. THEY ALREADY GAVE THE SUTURES AWAY TO DEPARTMENTS AND THEY GOT RID OF ALL THE BOXES. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20787736 ↗
• MalfunctionNov 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ABDOMINAL CLOSURE VETERINARY PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER CUSTOMER THAT SUTURE KEEPS COMING OFF THE NEEDLE MIDWAY THROUGH SURGERY. THIS HAS HAPPENED SIX TIMES TO THE 3-0 SERIES. THEY ALREADY GAVE THE SUTURES AWAY TO DEPARTMENTS AND THEY GOT RID OF ALL THE BOXES. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786467 ↗
• MalfunctionNov 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A ANIMAL UNDERWENT AN UNKNOWN ABDOMINAL CLOSURE VETERINARY PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER CUSTOMER THAT SUTURE KEEPS COMING OFF THE NEEDLE MIDWAY THROUGH SURGERY. THIS HAS HAPPENED SIX TIMES TO THE 3-0 SERIES. THEY ALREADY GAVE THE SUTURES AWAY TO DEPARTMENTS AND THEY GOT RID OF ALL THE BOXES. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786034 ↗
• MalfunctionNov 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A ANIMAL UNDERWENT AN UNKNOWN ABDOMINAL CLOSURE VETERINARY PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER CUSTOMER THAT SUTURE KEEPS COMING OFF THE NEEDLE MIDWAY THROUGH SURGERY. THIS HAS HAPPENED SIX TIMES TO THE 3-0 SERIES. THEY ALREADY GAVE THE SUTURES AWAY TO DEPARTMENTS AND THEY GOT RID OF ALL THE BOXES. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786003 ↗
• MalfunctionNov 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ABDOMINAL CLOSURE VETERINARY PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER CUSTOMER THAT SUTURE KEEPS COMING OFF THE NEEDLE MIDWAY THROUGH SURGERY. THIS HAS HAPPENED SIX TIMES TO THE 3-0 SERIES. THEY ALREADY GAVE THE SUTURES AWAY TO DEPARTMENTS AND THEY GOT RID OF ALL THE BOXES. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784755 ↗
• MalfunctionNov 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A AN ANIMAL UNDERWENT AN UNKNOWN ABDOMINAL CLOSURE VETERINARY PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER CUSTOMER THAT SUTURE KEEPS COMING OFF THE NEEDLE MIDWAY THROUGH SURGERY. THIS HAS HAPPENED SIX TIMES TO THE 3-0 SERIES. THEY ALREADY GAVE THE SUTURES AWAY TO DEPARTMENTS AND THEY GOT RID OF ALL THE BOXES. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784146 ↗
• MalfunctionNov 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20587833 ↗
• MalfunctionOct 15, 2024Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE HAD FALLEN APART AND THE ANIMAL EXPERIENCED A WOUND DEHISCENCE WHICH LED TO THE ANIMAL'S DEATH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 20452311 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. DURING THE ANIMAL SURGERY, THE MIDDLE OF SUTURE BREAKING DURING SURGERY AND POST SURGERY INCISION OPENED. THERE WAS NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906981 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. DURING THE ANIMAL SURGERY, THE MIDDLE OF SUTURE BREAKING DURING SURGERY AND POST SURGERY INCISION OPENED. THERE WAS NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 19906977 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE SUTURE WAS BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690548 ↗
• MalfunctionMar 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022, AND SUTURE WAS USED. THE NEEDLE WAS LOOSE FROM THE SURGICAL THREAD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18903443 ↗
• MalfunctionOct 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE SURGERY WHILE PULLING THE SUTURE OUT OF THE TROCAR THE NEEDLE POPPED OFF THE SUTURE. ANOTHER SUTURE WAS USED TO CONTINUE WITH THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18023679 ↗