PDS PDP303HRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031047969), received between May 16, 2018 and Nov 21, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, WHEN PDP303H WAS USING, THE NEEDLE AND THE SUTURE WERE DETACHED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618777 ↗
• MalfunctionOct 24, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THREAD BROKEN 2 CM FROM NEEDLE. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994916 ↗
• MalfunctionOct 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17974458 ↗
• MalfunctionOct 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17974457 ↗
• MalfunctionOct 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17974455 ↗
• MalfunctionJun 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RHINOPLASTY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE GOT DETACHED FROM THE SUTURE THREAD WHEN PERFORMING THE SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17219307 ↗
• MalfunctionJun 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM SUTURE WHILE IN USE. IT HAPPENED MORE THAN 5 TIMES WITH THE SAME LOT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17158544 ↗
• MalfunctionJun 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM SUTURE WHILE IN USE. IT HAPPENED MORE THAN 5 TIMES WITH THE SAME LOT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17158469 ↗
• MalfunctionJun 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM SUTURE WHILE IN USE. IT HAPPENED MORE THAN 5 TIMES WITH THE SAME LOT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17158421 ↗
• MalfunctionJun 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM SUTURE WHILE IN USE. IT HAPPENED MORE THAN 5 TIMES WITH THE SAME LOT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17158379 ↗
• MalfunctionJun 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM SUTURE WHILE IN USE. IT HAPPENED MORE THAN 5 TIMES WITH THE SAME LOT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17158378 ↗
• MalfunctionAug 4, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FRACTURE OF LEFT FEMORAL NECK SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, PULLING OFF OF THE SUTURE NEEDLE OCCURRED WHILE PLACING THE FIRST STITCH. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12273504 ↗
• MalfunctionAug 15, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT RHINOPLASTY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE UNCOUPLED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8896324 ↗
• MalfunctionMay 16, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEMICOLECTOMY ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULL-OFF DURING TISSUE PASSAGE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAD BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7518317 ↗