PDS PDP507GRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031048478), received between Jun 7, 2018 and Jun 30, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (8 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.

• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS BROKEN DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22361980 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE NEEDLE TIP WAS BROKEN AFTER TWO OR THREE STITCHES. NO REMAINING INSIDE THE BODY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306810 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE 4-0PDSPLUS WAS BROKEN. PREVIOUSLY NON-ANTIMICROBIAL Z507G WAS USED AND HAD NO PROBLEMS, BUT SINCE SWITCHING TO ANTIMICROBIAL, THE SUTURES BREAK FREQUENTLY. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067030 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE 4-0PDSPLUS WAS BROKEN. PREVIOUSLY NON-ANTIMICROBIAL Z507G WAS USED AND HAD NO PROBLEMS, BUT SINCE SWITCHING TO ANTIMICROBIAL, THE SUTURES BREAK FREQUENTLY. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067025 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE 4-0PDSPLUS WAS BROKEN. PREVIOUSLY NON-ANTIMICROBIAL Z507G WAS USED AND HAD NO PROBLEMS, BUT SINCE SWITCHING TO ANTIMICROBIAL, THE SUTURES BREAK FREQUENTLY. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067024 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE 4-0PDSPLUS WAS BROKEN. PREVIOUSLY NON-ANTIMICROBIAL Z507G WAS USED AND HAD NO PROBLEMS, BUT SINCE SWITCHING TO ANTIMICROBIAL, THE SUTURES BREAK FREQUENTLY. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067023 ↗
• MalfunctionFeb 26, 2024Material Separation; Difficult to Open or Remove Packaging Material; Material Separation; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE-SUTURE COULD NOT BE TAKEN OUT OF THE PACKAGE SMOOTHLY AND ALSO THE NEEDLE WAS EASILY DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18783952 ↗
• MalfunctionJan 9, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18477140 ↗
• MalfunctionAug 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE-SUTURE WAS BROKEN IMMEDIATELY DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17512926 ↗
• MalfunctionNov 3, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020; AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10778026 ↗
• MalfunctionAug 27, 2018Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT THE SUTURE LOOKED THICKER THAN USUAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7818289 ↗
• MalfunctionAug 27, 2018Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT THE SUTURE LOOKED THICKER THAN USUAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7818256 ↗
• MalfunctionAug 27, 2018Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT THE SUTURE LOOKED THICKER THAN USUAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7818250 ↗
• MalfunctionJun 7, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONECTOMY PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE NEEDLE DETACHED FROM THE SUTURE DURING CONTINUOUS SUTURING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7580271 ↗