PDS PDP423HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031048270), received between May 2, 2018 and Apr 8, 2022 — classified as 3 malfunctions.

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

• MalfunctionApr 8, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE (B)(6) 2022. AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE WOUND WAS CLOSED, THE SURGEON HAD AN UNUSUAL FEELING AT THE FIRST STICH DURING SUTURING FAT. THE SURGEON REALIZED THAT THE NEEDLE WAS BROKEN AT THE SWAGE PART. AN X-RAY WAS PERFORMED TO CHECK FOR ANY BROKEN NEEDLE REMAINING IN THE BODY, AND THE NEEDLE WHICH WAS REMAINING IN THE FAT LAYER WAS RETRIEVED. THE OPERATION TIME WAS EXTENDED OVER 30 MINUTES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14058544 ↗
• MalfunctionAug 23, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURING THE NAVEL, THE NAVEL WAS HARD AND DIFFICULT TO SUTURE, THEN THERE WAS A BREAKING SOUND, AND THE SWAGE PART OF THE NEEDLE HAD BEEN BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356650 ↗
• MalfunctionMay 2, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE NEEDLE BROKE AT THE SWAGE PART DURING USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7481134 ↗