PDS PDP432HRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031048287), received between Oct 28, 2019 and Jul 9, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE NEEDLE WAS BROKEN AT THE PROXIMAL END DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22457983 ↗
• MalfunctionMay 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE NURSE AT THE OPERATION ROOM SAID THAT THE SUTURE WAS BROKEN BOTH WHEN TYING THE SUTURE AND TAKING OUT THE SUTURE FROM THE PACKAGE. ALTHOUGH ANOTHER LOT OF THE PRODUCT WAS USED, THE SUTURE ALSO WAS BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WAS NO PROBLEM TO THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019255 ↗
• MalfunctionJul 1, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILIARY RECONSTRUCTION PROCEDURE ON (B)(6) 2022 HAND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURING. THIS HAPPENED SEVERAL TIMES. THE PRODUCT WAS USED ON SMALL INTESTINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14891367 ↗
• MalfunctionJul 1, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILIARY RECONSTRUCTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURING. THIS HAPPENED SEVERAL TIMES. THE PRODUCT WAS USED ON SMALL INTESTINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14891185 ↗
• MalfunctionJul 1, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILIARY RECONSTRUCTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURING. THIS HAPPENED SEVERAL TIMES. THE PRODUCT WAS USED ON SMALL INTESTINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14890944 ↗
• MalfunctionOct 28, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9246634 ↗
• MalfunctionOct 28, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING SUTURING. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9245185 ↗