PDS Z353HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031060722), received between Apr 25, 2018 and Jun 13, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENTERORRAPHY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. WHILE PASSING THE POINT IN THE APONEUROSIS, THE THREAD BECAME DISASSEMBLED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14680097 ↗
• MalfunctionJun 13, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENTERORRAPHY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. WHILE PASSING THE POINT IN THE APONEUROSIS, THE THREAD BECAME DISASSEMBLED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14679910 ↗
• MalfunctionApr 25, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT ABDOMINAL LIPECTOMY PROCEDURE ON (B)(6) 2017 AND SUTURE WAS USED. THE THREAD OF THE NEEDLE WAS DISASSEMBLED (PULLED OFF) DURING KNOTTING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7461201 ↗