PDS PDP127HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031047907), received between Mar 19, 2020 and Oct 28, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 7, 2025Open, Classified

   Identified curing issues with the silicone during the needles manufacturing process.

   Z-1513-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KIDNEY TRANSPLANT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A KIDNEY TRANSPLANT RECIPIENT, DURING ANASTOMOSIS, DOCTOR PICKED UP THE SUTURE TO START TYING THE KNOT WHEN THE SUTURE SNAPPED COMPLETELY. DOCTOR OPENED A SECOND SUTURE AND HAD TO DO THE WHOLE ANASTOMOSIS OVER AGAIN. CASE WAS ABLE TO BE COMPLETED. NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20546608 ↗
• MalfunctionMar 19, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CHILD PROCEDURE ON AN UNKNOWN DATE AND THE SUTURE WAS USED. DURING USUAL MANIPULATION WITH SIMPLE TRACTION, THE THREAD WAS CUT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9857608 ↗