PROLENE M8702Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10705031045774), received between Nov 29, 2017 and Jun 3, 2026 — classified as 77 malfunctions.

The most frequently reported specific device problem is “Material Separation” (42 reports).

21 other recalls cover devices cleared under the same FDA submission (K133356); they may or may not involve this specific model.

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 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026

  ONE OF THE NEEDLES IN THE PACK WAS "VERY BLUNT" DURING DISTAL VEIN GRAFT ANASTOMOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25373590 ↗
• MalfunctionApr 9, 2026

  MISSING SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 24828398 ↗
• MalfunctionSep 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE IN 2025 AND SUTURE WAS USED. THE SUTURES ARE BREAKING MID STRAND AND NEEDLE HAS POPPED OFF THE SUTURES DURING USE. THEY HAD TO RESTART THE ANASTOMOSIS WITH A FRESH SUTURE FROM OFF THE SHELF. LONGER PROCEDURE TIME. NO ISSUES AFTER RETRIEVING A NEW STITCH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23010556 ↗
• MalfunctionSep 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE IN 2025 AND SUTURE WAS USED. THE SUTURES ARE BREAKING MID STRAND AND NEEDLE HAS POPPED OFF THE SUTURES DURING USE. THEY HAD TO RESTART THE ANASTOMOSIS WITH A FRESH SUTURE FROM OFF THE SHELF. LONGER PROCEDURE TIME. NO ISSUES AFTER RETRIEVING A NEW STITCH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23010246 ↗
• MalfunctionJun 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. WHEN USING THE SUTURE, THE NEEDLE WILL POP OFF THIS MACHINES NOT SUPPOSE TO POP OFF. NO NEEDLE WHERE LOSS NO PATIENT WAS HARMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153856 ↗
• MalfunctionMar 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED FOR THE ANASTOMOSIS. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE. THERE WAS NO PROBLEM WHEN A DIFFERENT PACKAGE WAS USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21538153 ↗
• MalfunctionMar 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED FOR THE ANASTOMOSIS. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE. THERE WAS NO PROBLEM WHEN A DIFFERENT PACKAGE WAS USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21538146 ↗
• MalfunctionJan 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 20024 AND A SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE DURING VASCULAR ANASTOMOSIS. A NEW PACKAGE WAS OPENED AND USED, BUT THE SAME PROBLEM OCCURRED. THE OTHER PACKAGE WAS OPENED AGAIN AND USED WITHOUT PROBLEMS. 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 21118099 ↗
• MalfunctionJan 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 AND A SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE DURING VASCULAR ANASTOMOSIS. A NEW PACKAGE WAS OPENED AND USED, BUT THE SAME PROBLEM OCCURRED. THE OTHER PACKAGE WAS OPENED AGAIN AND USED WITHOUT PROBLEMS. 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 21118091 ↗
• MalfunctionSep 17, 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 THE SALES REP THAT THE PRODUCT WAS SPLITTING AS HE USED THESE SUTURES IN A CASE. ALL THE INFORMATION SALES REP WAS GIVEN AT THE TIME. CASE WAS COMPLETED. NO PATIENT HARM. AVAILABILITY OF RETURN OF PRODUCT UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241978 ↗
• MalfunctionSep 17, 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 THE SALES REP THAT THE PRODUCT WAS SPLITTING AS HE USED THESE SUTURES IN A CASE. ALL THE INFORMATION SALES REP WAS GIVEN AT THE TIME. CASE WAS COMPLETED. NO PATIENT HARM. AVAILABILITY OF RETURN OF PRODUCT UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241914 ↗
• MalfunctionNov 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT THE SUTURE BROKE DURING USE WAS THE INFORMATION PROVIDED BY THE COORDINATOR. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18080812 ↗
• MalfunctionSep 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THAT WHILE USING A SUTURE THE NEEDLES ARE POPPING FROM THE SUTURE WITHOUT TENSION PLACED. SURGEON SAID NO FORCE WAS USED, JUST THEIR NORMAL TECHNIQUE. UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17826454 ↗
• MalfunctionSep 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THAT WHILE USING A SUTURE THE NEEDLES ARE POPPING FROM THE SUTURE WITHOUT TENSION PLACED. SURGEON SAID NO FORCE WAS USED, JUST THEIR NORMAL TECHNIQUE. UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17826444 ↗
• MalfunctionAug 14, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ANASTOMOSIS PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WAS COMPLETING THE ANASTOMOSIS AND GOING TO TIE THE SUTURE TOGETHER AT THE END OF THE SUTURING, THE SUTURE BROKE. HE GRABBED A SECOND SUTURE TO USE A REINFORCEMENT STITCH AND THAT ONE BROKE AS WELL. OPENED A NEW LOT NUMBER AND THE SUTURE WORKED TO FINISH THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17547326 ↗
• MalfunctionAug 14, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ANASTOMOSIS PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WAS COMPLETING THE ANASTOMOSIS AND GOING TO TIE THE SUTURE TOGETHER AT THE END OF THE SUTURING, THE SUTURE BROKE. HE GRABBED A SECOND SUTURE TO USE A REINFORCEMENT STITCH AND THAT ONE BROKE AS WELL. OPENED A NEW LOT NUMBER AND THE SUTURE WORKED TO FINISH THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17547316 ↗
• MalfunctionJul 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ENDARTERECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE. IT WAS RETRIEVED AND A NEW SUTURE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17350564 ↗
• MalfunctionJul 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES POPPED OFF THE SUTURE. NO FURTHER DETAILS INCLUDED. UNSURE OF ACTUAL CASE TYPE. UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY OR IF THERE WAS ANY PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17317586 ↗
• MalfunctionJul 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES POPPED OFF THE SUTURE. NO FURTHER DETAILS INCLUDED. UNSURE OF ACTUAL CASE TYPE. UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY OR IF THERE WAS ANY PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17317583 ↗
• MalfunctionMay 31, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, ON THREE SEPARATE PROBLENE PACKS THE NEEDLE KEPT POPPING OFF. PROCEDURE WAS SUCCESSFULLY COMPLETED. A DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17031079 ↗
• MalfunctionMay 31, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) AND SUTURE WAS USED. DURING THE PROCEDURE, ON THREE SEPARATE PROBLENE PACKS THE NEEDLE KEPT POPPING OFF. PROCEDURE WAS SUCCESSFULLY COMPLETED. A DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17031074 ↗
• MalfunctionMay 31, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, ON THREE SEPARATE PROBLENE PACKS THE NEEDLE KEPT POPPING OFF. PROCEDURE WAS SUCCESSFULLY COMPLETED. A DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17031054 ↗
• MalfunctionApr 28, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE NEEDLES SNAP EASILY WHILE STITCHING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16838624 ↗
• MalfunctionApr 28, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE NEEDLES SNAP EASILY WHILE STITCHING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16837498 ↗
• MalfunctionApr 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE POPPED OFF WHEN PASSING THE NEEDLE THROUGH THE GRAFT, IT CAME OFF THE SUTURE. ANOTHER DEVICE OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. THE WERE NO ADVERSE CONSEQUENCE FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16685818 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133356. One submission often covers many models, so check the product and lot details in each record.

• Z-1515-2025 · Mar 7, 2025 · Open, Classified
  PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
• Z-1096-2025 · Dec 20, 2024 · Open, Classified
  PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ca
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981

…and 6 more.