PDS PDP316HRecalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10705031048027), received between Dec 18, 2018 and May 5, 2026 — classified as 2 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Break” (36 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 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE USING A SUTURE, IT WAS OBSERVED THAT THE NEEDLE WAS DETACHED FROM THE THREAD. DUE TO THIS SITUATION, IT WAS NECESSARY TO REQUEST A SECOND UNIT FROM THE PHARMACY'S STORAGE AREA. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SURGICAL DELAYS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083329 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2026 AND SUTURE WAS USED. SUTURE IS SNAPPING DURING USE- NORMAL HANDLING AND TENSION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387888 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2026 AND SUTURE WAS USED. SUTURE IS SNAPPING DURING USE- NORMAL HANDLING AND TENSION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387886 ↗
• MalfunctionJan 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC OMENTOPEXY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING LAPAROSCOPIC OMENTOPEXY, THE SUTURE WITH AN SH NEEDLE BECAME SEPARATED FROM THE SUTURE ON THE SECOND TO LAST PASS OF A CONTINUOUS SUTURE. THE SURGEON THOUGHT THAT HE MAY HAVE PULLED ON IT A LITTLE HARD AND THAT HE PULLED ON THE NEEDLE AT RIGHT AN ANGLE TO THE SUTURE WHICH MAY HAVE ALSO BEEN A FACTOR. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO MEDICAL INTERVENTION WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24057613 ↗
• MalfunctionNov 17, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BREAKING AND STRING OFF NEEDLE UNABLE TO TIE/USE. NO ADVERSE EFFECT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23571564 ↗
• MalfunctionJan 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON THAT THE TIP OF NEEDLE BROKE WHILE SUTURING PATIENT CLOSED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. DEVICE WAS RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129654 ↗
• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC BYPASS ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES BREAKING WITH NO CHANGE IN USUAL PRACTICE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895673 ↗
• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC BYPASS ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES BREAKING WITH NO CHANGE IN USUAL PRACTICE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895655 ↗
• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC BYPASS ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES BREAKING WITH NO CHANGE IN USUAL PRACTICE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895551 ↗
• MalfunctionOct 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLEEVE GASTRECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. A SUTURE WAS BEING USED TO EFFECT A REPAIR TO A SMALL DEFECT ON A PATIENT¿S STOMACH DURING A LAP SLEEVE GASTRECTOMY. WHEN THROWING THE FIRST PASS THROUGH STOMACH TISSUE THE SUTURE CAME APART AS THE SURGEON WAS PULLING THE SUTURE THROUGH THE TISSUE BY GRASPING THE NEEDLE TO DO SO. IT BROKE OFF APPROXIMATELY 3-5MM FROM THE END OF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20545842 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE AND SUTURE SEPARATED DURING USE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20505510 ↗
• MalfunctionSep 23, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING SUTURING IN THEATRE NEEDLE SNAPPED INSIDE PATIENT. REQUIRED X-RAY TO DETECT NEEDLE IN PATIENT AND THEN REMOVED BY DOCTOR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20281163 ↗
• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT THE FACILITY IS HAVING ISSUE WITH THE PRODUCT. IT WAS BREAKING APART AS PER NEW ADDITIONAL INFORMATION RECEIVED. UNKNOWN NUMBER OF STERILE SAMPLES RETURNING. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267816 ↗
• MalfunctionMay 3, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURE BREAKS DURING SEWING. NO REPORTED ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19237923 ↗
• MalfunctionMay 3, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURE BREAKS DURING SEWING. NO REPORTED ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19237921 ↗
• MalfunctionMay 3, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURE BREAKS DURING SEWING. NO REPORTED ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19237920 ↗
• MalfunctionApr 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS CUT WHEN THE STITCH WAS MADE IN THE TISSUE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19158836 ↗
• MalfunctionApr 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS CUT AT THE TIME OF MAKING THE STITCH IN THE TISSUE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154721 ↗
• MalfunctionMar 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18854732 ↗
• MalfunctionFeb 6, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY ON 11-JAN-2024 AND SUTURE WAS USED. THE NEEDLE BROKE AT THE SWAGE INTRA OP. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18654909 ↗
• MalfunctionDec 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ESOPHAGUS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BREAKING. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18368402 ↗
• MalfunctionSep 28, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC BYPASS PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE SNAPPED WHEN TENSION WAS APPLIED. A NEW SUTURE WAS USED AFTER THE EVENT OCCURRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT AND FRAGMENTS WERE NOT GENERATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17834105 ↗
• MalfunctionSep 21, 2023Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE CUSTOMER THE SUTURE KEPT 'SLIPPING OUT.' NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17795672 ↗
• MalfunctionSep 15, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ESOPHAGUS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BREAKING. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756913 ↗
• MalfunctionAug 14, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING USE AND THIS HAPPENED SEVERAL TIMES IN A ROW. A DIFFERENT PRODUCT WAS USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17546796 ↗