PDS Z341HRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031060647), received between Feb 27, 2018 and Oct 17, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ILEOSTOMY CLOSURE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. NEEDLE WAS ARMED AT THE SWAGE AND BROKE WHILE SUTURING FASCIA. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324869 ↗
• MalfunctionNov 25, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN CLOSING A WOUND, THE SURGEON WAS PULLING ON THE NEEDLE WITH THE NEEDLE DRIVER AND THE NEEDLE POPPED OFF THE SUTURE STRAND. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9368676 ↗
• MalfunctionNov 5, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE IN 2019 AND THE SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE BROKE IN TWO PIECES. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9278924 ↗
• MalfunctionOct 15, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE TIP BROKE IN THE PATIENT AT THE TIME OF USE AND IT WAS NOT FOUND. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9193205 ↗
• MalfunctionJul 1, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE BROKE WHEN TRYING TO CLOSE THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8751066 ↗
• MalfunctionJul 1, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE BROKE WHEN TRYING TO CLOSE THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8751062 ↗
• MalfunctionFeb 27, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2017 AND SUTURE WAS USED. DURING USE THE SUTURE DISCONNECTED FROM THE THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7300129 ↗
• MalfunctionFeb 27, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2017 AND SUTURE WAS USED. DURING USE THE SUTURE DISCONNECTED FROM THE THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7300128 ↗
• MalfunctionFeb 27, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2017 AND SUTURE WAS USED. DURING USE THE SUTURE DISCONNECTED FROM THE THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7300127 ↗