PDS PDP126HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031047891), received between Dec 20, 2021 and Jul 27, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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.

• MalfunctionJul 27, 2026Material Separation

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. The suture was detached while tying the node. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50001813 ↗
• MalfunctionJun 12, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT NA UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHILE SUTURING, THE SUTURE WAS DETACHED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488955 ↗
• MalfunctionDec 20, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREAS ANASTOMOSIS PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE AND NEEDLE DETACHED EASILY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13044082 ↗