PROLENE EP8704HRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10705031206779), received between Mar 9, 2020 and Dec 19, 2025 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE THREAD IS UNWOUND FROM THE NEEDLE IN THE SUTURE. THE SURGERY WAS DELAYED BY 15 MINUTES. ANOTHER SUTURE WAS TAKEN AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO FRAGMENTS GENERATED AND NO ADVERSE PATIENT CONSEQUENCES. THE SURGEON WAS CAUTIONS AND IT REMAINED IN THE NEEDLE HOLDER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23855383 ↗
• MalfunctionDec 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE THREAD IS UNWOUND FROM THE NEEDLE IN THE SUTURE. THE SURGERY WAS DELAYED BY 15 MINUTES. ANOTHER SUTURE WAS TAKEN AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO FRAGMENTS GENERATED AND NO ADVERSE PATIENT CONSEQUENCES. THE SURGEON WAS CAUTIONS AND IT REMAINED IN THE NEEDLE HOLDER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853562 ↗
• MalfunctionMay 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE-THREAD DETACHMENT OCCURRED WHILE MAKING THE ANASTOMOSIS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES, HOWEVER, THE PROCEDURE TOOK LONGER THAN EXPECTED, AND THE SUTURES UTILIZATION WERE HIGHER THAN NECESSARY BECAUSE OF THE NEEDLE DETACHMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994157 ↗
• MalfunctionMay 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE-THREAD DETACHMENT OCCURRED WHILE MAKING THE ANASTOMOSIS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES, HOWEVER, THE PROCEDURE TOOK LONGER THAN EXPECTED, AND THE SUTURES UTILIZATION WERE HIGHER THAN NECESSARY BECAUSE OF THE NEEDLE DETACHMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994155 ↗
• MalfunctionMay 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE-THREAD DETACHMENT OCCURRED WHILE MAKING THE ANASTOMOSIS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES, HOWEVER, THE PROCEDURE TOOK LONGER THAN EXPECTED, AND THE SUTURES UTILIZATION WERE HIGHER THAN NECESSARY BECAUSE OF THE NEEDLE DETACHMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994153 ↗
• MalfunctionJan 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16215157 ↗
• MalfunctionJan 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16215156 ↗
• MalfunctionJan 3, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE THE SURGEON HAD AN ISSUE WITH THE SUTURE, AND IT WAS THIRD TIME IN LAST 7 DAYS. THE SUTURE BROKE DURING KNOTTING. AFTER THE ISSUE WAS OBSERVED, THE SURGEON OPENED A NEW BOX OF SAME SUTURE AND FINISHED PROCEDURE WITHOUT ANY COMPLICATIONS FOR PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16091471 ↗
• MalfunctionDec 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE THE DOCTOR HAD ISSUES WITH THE SUTURE; ALL NINE WERE BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16056850 ↗
• MalfunctionDec 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE THE DOCTOR HAD ISSUES WITH THE SUTURE; ALL NINE WERE BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16056834 ↗
• MalfunctionDec 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE THE DOCTOR HAD ISSUES WITH THE SUTURE, ALL NINE WERE BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16056825 ↗
• MalfunctionDec 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE THE DOCTOR HAD ISSUES WITH THE SUTURE; ALL NINE WERE BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16056817 ↗
• MalfunctionDec 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE THE DOCTOR HAD ISSUES WITH THE SUTURE; ALL NINE WERE BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16056811 ↗
• MalfunctionDec 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE THE DOCTOR HAD ISSUES WITH THE SUTURE; ALL NINE WERE BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16056807 ↗
• MalfunctionDec 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE THE DOCTOR HAD ISSUES WITH THE SUTURE, ALL NINE WERE BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16056798 ↗
• MalfunctionDec 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2022 AND SUTURE WAS USED. DURING THE PROCEDURE THE DOCTOR HAD ISSUES WITH THE SUTURE, ALL NINE WERE BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16056794 ↗
• MalfunctionDec 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE THE DOCTOR HAD ISSUES WITH THE SUTURE; ALL NINE WERE BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16056783 ↗
• MalfunctionMay 31, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT 5 SUTURES BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14550050 ↗
• MalfunctionMay 31, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT 5 SUTURES BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14550048 ↗
• MalfunctionMay 31, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON 05/09/2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT 5 SUTURES BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14550044 ↗
• MalfunctionMay 31, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT 5 SUTURES BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14550043 ↗
• MalfunctionMay 31, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT 5 SUTURES BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14550042 ↗
• MalfunctionNov 23, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN CABG ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, AT THE MOMENT TO PUT THE STITCHES, THE NEEDLE IS DISASSEMBLED. THE SURGERY WAS DELAYED BY 20 MINUTES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12864022 ↗
• MalfunctionNov 23, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN CABG ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, AT THE MOMENT TO PUT THE STITCHES, THE NEEDLE IS DISASSEMBLED. THE SURGERY WAS DELAYED BY 20 MINUTES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12864015 ↗
• MalfunctionNov 23, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN CABG ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, AT THE MOMENT TO PUT THE STITCHES, THE NEEDLE IS DISASSEMBLED. THE SURGERY WAS DELAYED BY 20 MINUTES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12864011 ↗

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-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292

…and 6 more.