PDS PDP845GRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031048638), received between Dec 31, 2025 and Aug 3, 2026 — classified as 2 injuries, 1 malfunction.

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. 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.

• InjuryAug 3, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50122498 ↗
• InjuryJul 31, 2026Break

  It was reported that a patient underwent an unknown cardiovascular surgery on an unknown date and suture was used for buried dermal closure. During the procedure, the needle was broken. It occurred with 2 sutures with the same lot in a row. Half of the needle remained inside the patient's body. The doctor insisted that nothing could possibly remain inside the patient's body, so the incision was closed; however, a foreign matter was detected on the post-operative X-ray, and a CT scan revealed that the tip of one of the two broken pieces had not been found, and that approximately half of that piece remained inside the patient's body. Reoperation was performed but the broken needle was not found. The patient is stable after reoperation. The surgeon opined that at least, it had not fallen into the thoracic cavity, so it may be expelled eventually. The patient will proceed with observation. As the patient had a history of the same surgery, it is possible that the skin was stiff. Additional information was requested.

  Patient problems: Foreign Body In Patient

  MAUDE report 50098399 ↗
• MalfunctionDec 31, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT NEEDLE BREAKAGE WAS OBSERVED. IT WAS REPORTED AFTER OPENING THE PACKAGE, THE NEEDLE TIP WAS UNUSUALLY BENT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936084 ↗