PDS Z513GRecalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10705031061354), received between Jan 10, 2018 and Nov 3, 2025 — classified as 12 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Break” (33 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. THE LOT NUMBER WILL BE REPORTED AT A LATER DATE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457461 ↗
• MalfunctionAug 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN OB-GYN SURGERY, 4-0PDS WAS USED FOR BURIED SUTURES. THERE WERE NO PROBLEMS WHEN A SCRUB NURSE ATTACHED THE NEEDLE TO THE NEEDLE HOLDER AND HANDED IT TO THE DOCTOR. THE SUTURE WAS BROKEN EVEN THOUGH NO APPLYING FORCE WHEN TYING AND THE DOCTOR APPLIED THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THE CUSTOMER REQUESTED TO CONDUCT THE SUTURE PULLING TEST. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22797645 ↗
• MalfunctionAug 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN OB-GYN SURGERY, 4-0PDS WAS USED FOR BURIED SUTURES. THERE WERE NO PROBLEMS WHEN A SCRUB NURSE ATTACHED THE NEEDLE TO THE NEEDLE HOLDER AND HANDED IT TO THE DOCTOR. THE SUTURE WAS BROKEN EVEN THOUGH NO APPLYING FORCE WHEN TYING AND THE DOCTOR APPLIED THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THE CUSTOMER REQUESTED TO CONDUCT THE SUTURE PULLING TEST. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22797639 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY ON (B)(6) 2025 AND SUTURE WAS USED ON THE DERMIS. DURING THE PROCEDURE, THE SUTURE WAS BROKEN ALTHOUGH NO EXTRA TENSION WAS APPLIED. 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 22029949 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE UNKNOWN SURGERY, TWO NEEDLES WERE BROKEN IN A ROW DURING USE. THE 1ST ONE WAS DISCARDED, BUT THE 2ND ONE WOULD BE RETURNED. IT WAS NOT A CONTROL RELEASE NEEDLE. IT WAS CONFIRMED THAT NO PIECES OF THE NEEDLE DUE TO BROKEN NEEDLES FELL INTO THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21861774 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE UNKNOWN SURGERY, TWO NEEDLES WERE BROKEN IN A ROW DURING USE. THE 1ST ONE WAS DISCARDED, BUT THE 2ND ONE WOULD BE RETURNED. IT WAS NOT A CONTROL RELEASE NEEDLE. IT WAS CONFIRMED THAT NO PIECES OF THE NEEDLE DUE TO BROKEN NEEDLES FELL INTO THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21861773 ↗
• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. THE SUTURES WERE 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 21740443 ↗
• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. THE SUTURES WERE 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 21740420 ↗
• MalfunctionJan 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO SAMPLE WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21184004 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE BREAKAGE OCCURRED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21095768 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE BREAKAGE OCCURRED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21095767 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE BREAKAGE OCCURRED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21095766 ↗
• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, THE SUTURE WAS BROKEN AT ABOUT 2 CENTIMETERS BELOW THE NEEDLE. THE OPERATION TIME WAS NO EXTENSION. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891294 ↗
• MalfunctionJun 17, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN OB-GYN PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE SURGERY, AFTER HOLDING THE NEEDLE WITH THE NEEDLE-HOLDER, WHEN TAKING IT OUT, THE NEEDLE WAS BROKEN 2 CM FROM THE CONNECTION PART. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547778 ↗
• MalfunctionFeb 21, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. THE SUTURE BROKE EASILY 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 18747769 ↗
• MalfunctionFeb 21, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. THE SUTURE BROKE EASILY 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 18747765 ↗
• MalfunctionAug 8, 2023Material Separation; Material Separation

  IT WAS REPORTED, A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2023. AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE, DURING USE. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17482151 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE PATIENT DEVELOPED SIGNS OF INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Breast Discomfort/Pain; Erythema; Local Reaction; Pocket Erosion; Unspecified Infection

  MAUDE report 17295579 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE PATIENT DEVELOPED SIGNS OF INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Local Reaction; Unspecified Infection

  MAUDE report 17295577 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE PATIENT DEVELOPED SIGNS OF INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 17295576 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. THE PATIENT DEVELOPED SIGNS OF INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 17295528 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE PATIENT DEVELOPED SIGNS OF INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Breast Discomfort/Pain; Erythema; Purulent Discharge; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 17295525 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE PATIENT DEVELOPED SIGNS OF INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 17295523 ↗
• InjuryJul 10, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. THE PATIENT DEVELOPED SIGNS OF INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 17295522 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. THE PATIENT DEVELOPED SIGNS OF INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Breast Discomfort/Pain; Erythema; Hematoma; Purulent Discharge; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 17295521 ↗