PDS Z358TRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031060760), received between May 5, 2021 and Apr 16, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A SURGERY, THE SURGEON WAS UNABLE TO VISUALIZE THE SUTURE LINE AND NOTED THAT THE MIDDLE PORTION OF THE SUTURE LINE HAD COMPLETELY DISAPPEARED. UPON POSTOPERATIVE ASSESSMENT, WHEN THE SURGEON EVALUATED THE PATIENT, THE SUTURE WAS NO LONGER PRESENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24899739 ↗
• InjuryApr 16, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. FOUR DAYS POSTOPERATIVELY, THE PHYSICIAN OBSERVED THAT THE MIDDLE PORTION OF THE SUTURE WAS MISSING, RESULTING IN WOUND DEHISCENCE. THE PATIENT WAS RETURNED TO THE PROCEDURE ROOM, AND THE WOUND WAS RE-SUTURED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Wound Dehiscence

  MAUDE report 24899738 ↗
• MalfunctionMar 3, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. AFTER A STITCH WAS SEWN DURING THE OPERATION, THE THREAD BROKE AND A NEW THREAD WAS REPLACED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24503875 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE ON BOTH PRODUCTS DURING THE PROCEDURE. THE TIP OF THE NEEDLE WAS NOT RETRIEVABLE; THEY HAVE A PHOTO ALSO. THERE IS NO ADVERSE IMPACT ON PATIENT/USER REPORTED. DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23695036 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE ON BOTH PRODUCTS DURING THE PROCEDURE. THE TIP OF THE NEEDLE WAS NOT RETRIEVABLE, THEY HAVE A PHOTO ALSO. THERE IS NO ADVERSE IMPACT ON PATIENT/USER REPORTED. DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451601 ↗
• MalfunctionJun 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CLOSURE OF ABDOMINAL FASCIA PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT THE SUTURE PRODUCT BROKE WITHOUT ANY FORCE OR DAMAGE. WE OPENED ANOTHER ONE FROM THE SAME BOX AND IT ALSO BROKE, SO THE BOX WAS REMOVED FROM SHELF. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22300106 ↗
• MalfunctionJun 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CLOSURE OF ABDOMINAL FASCIA PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT THE SUTURE PRODUCT BROKE WITHOUT ANY FORCE OR DAMAGE. WE OPENED ANOTHER ONE FROM THE SAME BOX AND IT ALSO BROKE, SO THE BOX WAS REMOVED FROM SHELF. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22300075 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. AT 19:00, THE PATIENT UNDERWENT SURGERY DUE TO LIVER AND SPLEEN RUPTURE. THE DOCTOR PREPARED TO CLOSE THE ABDOMINAL CAVITY, BUT WHEN USING SUTURE TO SUTURE THE ABDOMINAL MUSCLES HALFWAY, THE NEEDLE BROKE. THE INSTRUMENT NURSE CHECKED THAT THE BROKEN NEEDLE WAS INTACT AND THERE WAS NO POSSIBILITY OF MISSING THE ABDOMINAL CAVITY. A NEW NEEDLE WAS USED TO CONTINUE CLOSING THE ABDOMINAL CAVITY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066323 ↗
• MalfunctionApr 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE KEEPS BREAKING AWAY FROM THE SUTURE AFTER A FEW THROWS WITH THE SUTURE. THEY HAVE HAD TO GO THROUGH MULTIPLE SUTURES IN ONE SETTING. THERE WAS NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19107730 ↗
• MalfunctionApr 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 20-MAR-2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE KEEPS BREAKING AWAY FROM THE SUTURE AFTER A FEW THROWS WITH THE SUTURE. THEY HAVE HAD TO GO THROUGH MULTIPLE SUTURES IN ONE SETTING. THERE WAS NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19107717 ↗
• MalfunctionDec 1, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT HEMICOLECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SEWING THE COLON, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12912410 ↗
• MalfunctionMay 5, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGICAL PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE IS EASILY BROKEN WHEN TYING A KNOT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11779655 ↗