PDS D10058Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031134331), received between Jan 17, 2019 and Dec 16, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, WHEN THE CIRCULATING NURSE TRIED TO TAKE THE PRODUCT OUT OF THE PACKAGE INTO THE STERILE FIELD BEFORE USE, THE BOTTOM SEAL OF THE PACKAGE WAS ALREADY CUT OPEN, AS IF IT HAD BEEN SLIT SO THE HOSPITAL DID NOT USE IT AND OPENED A NEW ONE INSTEAD. 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. 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 23818194 ↗
• MalfunctionMar 22, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. AFTER OPENING THE PACKAGE BEFORE USE, IT WAS FOUND THAT 2 NEEDLES HAD BEEN DETACHED FROM 2 SUTURES. VISUAL INSPECTION EVALUATION WAS CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT ONE DETACHED NEEDLE AND SOME SUTURE PIECES ON THE DEGRADATION PROCESS THAT PERTAINS TO THE PRODUCT CODE D10058 WERE RECEIVED FOR EVALUATION. THE PRODUCT IS A CONTROL RELEASE; EACH PACKET SHOULD CONTAIN EIGHT STRANDS. UPON VISUAL ASSESSMENT OF THE SUTURE, IT WAS OBSERVED THAT THE STRAND HAVE BEGUN WITH A DEGRADATION PROCESS CAUSED BY EXPOSURE TO THE ENVIRONMENT. THIS CONDITION CONTRIBUTES TO THE NEEDLE SEPARATING FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590404 ↗
• MalfunctionMar 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. AFTER OPENING THE PACKAGE BEFORE USE, IT WAS FOUND THAT 2 NEEDLES HAD BEEN DETACHED FROM 2 SUTURES. UPON VISUAL ASSESSMENT OF THE SUTURES, IT WAS OBSERVED THAT THE STRANDS HAVE BEGUN WITH A DEGRADATION PROCESS CAUSED BY EXPOSURE TO THE ENVIRONMENT. THIS CONDITION CONTRIBUTES TO THE NEEDLE SEPARATING FROM THE SUTURE. THE FOIL WAS VISUALLY INSPECTED, AND EXCESSIVE WRINKLES AND HOLES IN THE CAVITY WERE OBSERVED DUE TO HANDLING. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16551184 ↗
• MalfunctionJan 17, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION PROCEDURE ON (B)(6) 2018, AND SUTURE WAS USED. THE SUTURE WAS USED ON DERMIS BY INTERRUPTED SUTURING AND THE NEEDLE TIP BROKE. THE SURGEON SEARCHED FOR THE TIP USING FLUOROSCOPY AND THE TIP WAS NOT FOUND. THE PROCEDURE WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8257737 ↗