PROLENE EPM8745Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10705031134836), received between Jun 17, 2019 and Aug 18, 2025 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. TOTAL 5 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22831266 ↗
• MalfunctionAug 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. TOTAL 5 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22831241 ↗
• MalfunctionAug 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY . TOTAL 5 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22831209 ↗
• MalfunctionAug 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. TOTAL 5 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22831198 ↗
• MalfunctionAug 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. TOTAL 5 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22831175 ↗
• MalfunctionJun 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERIAL BYPASS GRAFT PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE KEPT POPPING OFF THE SUTURE DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THE NEEDLES DID NOT FALL WITHIN THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19515929 ↗
• MalfunctionJun 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERIAL BYPASS GRAFT PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE KEPT POPPING OFF THE SUTURE DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THE NEEDLES DID NOT FALL WITHIN THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19515928 ↗
• MalfunctionJun 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERIAL BYPASS GRAFT PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE KEPT POPPING OFF THE SUTURE DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THE NEEDLES DID NOT FALL WITHIN THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19515927 ↗
• MalfunctionJun 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERIAL BYPASS GRAFT PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE KEPT POPPING OFF THE SUTURE DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THE NEEDLES DID NOT FALL WITHIN THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19515926 ↗
• MalfunctionMay 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERIAL BYPASS GRAFT PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE KEPT POPPING OFF THE SUTURE DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THE NEEDLES DID NOT FALL WITHIN THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19262329 ↗
• MalfunctionMay 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERIAL BYPASS GRAFT PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE KEPT POPPING OFF THE SUTURE DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THE NEEDLES DID NOT FALL WITHIN THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19262327 ↗
• MalfunctionJul 25, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN JUNE 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE BROKE WHEN SEWING IN AN UNKNOWN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15099667 ↗
• MalfunctionJul 25, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE BROKE WHEN SEWING IN AN UNKNOWN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15099548 ↗
• MalfunctionJul 21, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN SEWING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080801 ↗
• MalfunctionFeb 19, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFTING SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING THE PROXIMAL END OF THE BYPASS. THEN THE SUTURE NEEDED TO BE REMOVED FROM THE TISSUE. CHANGED TO ANOTHER DEVICE TO CONTINUE. THE SURGERY WAS DELAYED MORE THAN HALF HOUR. THE PATIENT IS STABLE IN HOSPITAL NOW. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11351215 ↗
• MalfunctionFeb 17, 2021Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING SEWING OF BRIDGING VASCULAR TISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11339930 ↗
• MalfunctionFeb 17, 2021Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING SEWING OF BRIDGING VASCULAR TISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11339866 ↗
• MalfunctionJul 27, 2020Break; 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 BROKE EASILY AND WAS CURLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10326159 ↗
• MalfunctionMar 10, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG HEART PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING THE DISTAL PORTION OF THE ANASTOMOSIS, THE SUTURE BROKE AT THE MID-POINT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9814990 ↗
• MalfunctionMar 10, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG HEART PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING THE DISTAL PORTION OF THE ANASTOMOSIS, THE SUTURE BROKE AT THE MID-POINT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9814988 ↗
• MalfunctionMar 10, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG HEART PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING THE DISTAL PORTION OF THE ANASTOMOSIS, THE SUTURE BROKE AT THE MID-POINT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9814987 ↗
• MalfunctionMar 10, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG HEART PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING THE DISTAL PORTION OF THE ANASTOMOSIS, THE SUTURE BROKE AT THE MID-POINT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9814986 ↗
• MalfunctionMar 10, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG HEART PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING THE DISTAL PORTION OF THE ANASTOMOSIS, THE SUTURE BROKE AT THE MID-POINT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9814985 ↗
• MalfunctionMar 10, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG HEART PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING THE DISTAL PORTION OF THE ANASTOMOSIS, THE SUTURE BROKE AT THE MID-POINT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9814984 ↗
• MalfunctionJun 17, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A VASCULAR OR HEART PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE IS POPPING OFF VERY FAST. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE AND DIFFERENT LOTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8705856 ↗

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-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• 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-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662

…and 6 more.