PDS PDP339HRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705031048096), received between Mar 17, 2020 and Feb 18, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. THE SUTURE CAME LOOSE FROM THE NEEDLE AND ENDED UP IN THE ABDOMEN OF THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379690 ↗
• MalfunctionFeb 18, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. THE SUTURE CAME LOOSE FROM THE NEEDLE AND ENDED UP IN THE ABDOMEN OF THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379688 ↗
• MalfunctionFeb 4, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE IS REMOVED DURING THE SURGICAL PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259658 ↗
• MalfunctionJan 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING OPEN CORONARY ARTERY BYPASS GRAFTING, THE SUTURE WAS DETACHED. 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 24119520 ↗
• MalfunctionMar 20, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A ANIMAL UNDERWENT A CANINE SPRAY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT POST OP OF AN CANINE SPAY PROCEDURE THAT THE PATIENT HAD A SUTURE THAT DID NOT DISSOLVE WHICH CREATED A SMALL MASS THAT NEEDING TO BE CUT OUT MONTHS LATER. THE MASS CREATED A SMALL ABSCESS THAT WAS OOZING AND WOULD NOT RESPOND TO ANTIBIOTICS. PATIENT CURRENTLY DOING BETTER AND HAS RECOVERED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Fluid Discharge

  MAUDE report 21652009 ↗
• MalfunctionSep 19, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHEN THE SURGEON WAS TRYING TO TIE KNOT, THE SUTURE BROKE. ANOTHER DEVICE WAS USED TO EFFECTIVELY TO COMPLETE THE CASE WITHOUT ANY PATIENT HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20264062 ↗
• MalfunctionFeb 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT AT THE TIME OF SUTURE CLOSURE OF VAGINAL STUMP, THE NEEDLE WAS DETACHED FROM THE SUTURE AT THE 2ND STITCH. ANOTHER PACKAGE WAS OPENED AND USED BUT THE SAME THING HAPPENED AGAIN. THESE WERE NOT CONTROL RELEASE NEEDLES. SUTURE METHOD WAS CONTINUOUS SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767015 ↗
• MalfunctionFeb 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT AT THE TIME OF SUTURE CLOSURE OF VAGINAL STUMP, THE NEEDLE WAS DETACHED FROM THE SUTURE AT THE 2ND STITCH. ANOTHER PACKAGE WAS OPENED AND USED BUT THE SAME THING HAPPENED AGAIN. THESE WERE NOT CONTROL RELEASE NEEDLES. SUTURE METHOD WAS CONTINUOUS SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767007 ↗
• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE SUBCUTANEOUS. IN THE WARD / ICU, AN INFECTION OCCURRED. THE CAUSE OF THE INFECTION WAS UNKNOWN. A SUBCUTANEOUS DRAIN WAS PLACED BECAUSE THE PATIENT WAS LARGE AND HAD THICK SUBCUTANEOUS SKIN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 17431427 ↗
• MalfunctionMay 5, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO TIE A KNOT WITH SUTURE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876819 ↗
• MalfunctionOct 28, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE EASILY DURING LIGATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15692714 ↗
• MalfunctionJul 30, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN PASSING THE NEEDLE THROUGH THE VAGINAL STUMP, THE SUTURE WAS DETACHED FROM THE NEEDLE. 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 12253528 ↗
• MalfunctionMay 18, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN LAPAROSCOPIC PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11843545 ↗
• MalfunctionSep 15, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE LOOKED FRAGILE AND FRAGMENTED AT THE MOMENT OF KNOTTING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10535292 ↗
• MalfunctionAug 31, 2020Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF THE SUTURE THEN BREAKING THE SUTURE IN HALF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10472283 ↗
• MalfunctionMar 17, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD DURING PASSAGE THROUGH THE TISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9843200 ↗