PDS Z432HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031060937), received between Aug 17, 2020 and Feb 20, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PEDIATRIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN EASILY, THERE WAS NO EFFECT ON THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21425955 ↗
• MalfunctionFeb 20, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PEDIATRIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN EASILY,THERE WAS NO EFFECT ON THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21425954 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREAS-SPARING DUODENECTOMY: PSD FOR DUODENAL MUCUS MEMBRANE CARCINOMA WITH INFILTRATION INTO THE SECOND PART OF THE DUODENUM ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR HAD SUTURED THE BILE DUCT AND THE MAIN PANCREATIC DUCT, AND AN ANASTOMOSIS BETWEEN THE COMMON CHANNEL AND THE JEJUNUM. THERE THE SUTURE WAS USED. IT WAS RECOGNIZED THAT HE HAD A DELAYED GASTRIC EMPTYING AT 4 DAYS AFTER OPERATION AND AN INFECTION AT 6 DAYS AFTER OPERATION. THE DOCTOR ADMINISTERED ANTIBIOTICS TO THE PATIENT, AND THE PATIENT RECOVERED. IN ADDITION, NO PANCREATIC LEAKAGE OCCURRED AFTER THE OPERATION. THE PATIENT WAS DISCHARGED 44 DAYS AFTER THE OPERATION. THEREAFTER, NO SIGNS OF RECURRENCE WERE RECOGNIZED FOR 6 MONTHS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 19484119 ↗
• MalfunctionAug 17, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS ALSO REPORTED THAT THE NEEDLE WAS DETACHED FROM THE SUTURE IMMEDIATELY DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10418317 ↗