PROLENE EP8741HRecalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 10705031206809), received between Apr 16, 2019 and Sep 2, 2026 — classified as 100 malfunctions.

The most frequently reported specific device problem is “Break” (57 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 100 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Structural Problem; Component Misassembled

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571265 ↗
• MalfunctionJul 8, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25746772 ↗
• MalfunctionJun 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SURGICAL PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE MATERIAL WHILE SUTURING. THE NEEDLE-SUTURE SEPARATION OCCURRED DURING NORMAL USE. THERE WAS A SURGICAL DELAY REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25536251 ↗
• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GET BREAK WHILE SUTURING, 2 FOILS HAS BROKEN FOR THE SAME CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363827 ↗
• MalfunctionMay 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, TWO SUTURES BROKE DURING THE PROCEDURE. TWO CONSECUTIVE COMPLAINTS HAS REPORTED. SURGEON USED ANOTHER FOIL TO COMPLETE THE PROCEDURE. TOTAL OF 25FOILS WERE USED AND AFTER THAT TWO CONSECUTIVE COMPLAINTS WERE REPORTED. FOLLOWING THIS, THE DOCTOR HAS REQUESTED US TO TAKE BACK THE REMAINING 9 FOILS AND REPLACE THEM WITH 11 FOILS FROM DIFFERENT BATCH INCLUDING TWO COMPLAINT SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25190773 ↗
• MalfunctionMay 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, TWO SUTURES BROKE DURING THE PROCEDURE. TWO CONSECUTIVE COMPLAINT HAS REPORTED. SURGEON USED ANOTHER FOILS TO COMPLETE THE PROCEDURE. TOTAL OF 25FOILS WERE USED AND AFTER THAT TWO CONSECUTIVE COMPLAINTS WERE REPORTED. FOLLOWING THIS, THE DOCTOR HAS REQUESTED US TO TAKE BACK THE REMAINING 9 FOILS AND REPLACE THEM WITH 11 FOILS FROM DIFFERENT BATCH INCLUDING TWO COMPLAINT SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25190763 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFTING PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE DOING CORONARY ARTERY BYPASS GRAFTING, THE SURGEON USING 3 X 8/0 PROLENE. ALL 3 SUTURES SNAPPED WHILE HE WAS TRYING TO USE LOT NO.107SSM ETHICON PROLENE ,REF .EP8741. SWITCHED TO ANOTHER PACKET OF 8.0 PROLENE WITH ANOTHER LOT NUMBER, WHICH WAS SUCCESSFUL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161770 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFTING PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE DOING CORONARY ARTERY BYPASS GRAFTING, THE SURGEON USING 3 X 8/0 PROLENE. ALL 3 SUTURES SNAPPED WHILE HE WAS TRYING TO USE LOT NO.107SSM ETHICON PROLENE ,REF .EP8741. SWITCHED TO ANOTHER PACKET OF 8.0 PROLENE WITH ANOTHER LOT NUMBER, WHICH WAS SUCCESSFUL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161767 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFTING PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE DOING CORONARY ARTERY BYPASS GRAFTING, THE SURGEON USING 3 X 8/0 PROLENE. ALL 3 SUTURES SNAPPED WHILE HE WAS TRYING TO USE LOT NO.107SSM ETHICON PROLENE, REF (B)(4). SWITCHED TO ANOTHER PACKET OF 8.0 PROLENE WITH ANOTHER LOT NUMBER, WHICH WAS SUCCESSFUL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161762 ↗
• MalfunctionMay 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFTING PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. WHILE DOING THE PROCEDURE, THE SURGEON USED 3 X 8/0 SUTURES. ALL 3 SUTURES SNAPPED WHILE TRYING TO USE, SO THE SURGEON USED SUTURES FROM ANOTHER BOX WHICH WAS SUCCESSFUL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149054 ↗
• MalfunctionMay 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFTING PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. WHILE DOING THE PROCEDURE, THE SURGEON USED 3 X 8/0 SUTURES. ALL 3 SUTURES SNAPPED WHILE TRYING TO USE, SO THE SURGEON USED SUTURES FROM ANOTHER BOX WHICH WAS SUCCESSFUL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149041 ↗
• MalfunctionMay 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFTING PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. WHILE DOING THE PROCEDURE, THE SURGEON USED 3 X 8/0 SUTURES. ALL 3 SUTURES SNAPPED WHILE TRYING TO USE, SO THE SURGEON USED SUTURES FROM ANOTHER BOX WHICH WAS SUCCESSFUL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149031 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LIVER RESECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. SUTURE BRECK DOWN AT THE TIME OF ANASTOMOSIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850094 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LIVER RESECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. SUTURE BREAK DOWN AT THE TIME OF ANASTOMOSIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850093 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LIVER RESECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. SUTURE BREAK DOWN AT THE TIME OF ANASTOMOSIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850092 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LIVER RESECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. SUTURE BREAK DOWN AT THE TIME OF ANASTOMOSIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850091 ↗
• MalfunctionNov 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP, THAT DURING A CABG PROCEDURE THE NEEDLE BROKE OFF DURING THE ANASTOMOSIS. THERE IS ADDITIONAL SUTURE BEING SENT BACK THAT THE TECH BROKE WHILE TAKING OUT OF THE PACK. THE TECH ADMITTED TO GRABBING THE SUTURE FROM THE STRAND. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE WAS RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582706 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. WHILE SUTURING THE DISTAL ANASTOMOSIS IN CABG SURGERY, FOUND THE SUTURE THREAD GETS SNAPPED WHILE APPLYING THE 1ST KNOT AFTER COMPLETING THE ENTIRE SUTURING, THIS HAS HAPPENED IN CONSECUTIVE 2 FOILS AND 3RD FOIL DR. USED WAS ABLE TO APPLY KNOT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23325067 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. WHILE SUTURING THE DISTAL ANASTOMOSIS IN CABG SURGERY, FOUND THE SUTURE THREAD GETS SNAPPED WHILE APPLYING THE 1ST KNOT AFTER COMPLETING THE ENTIRE SUTURING, THIS HAS HAPPENED IN CONSECUTIVE 2 FOILS AND 3RD FOIL DR. USED WAS ABLE TO APPLY KNOT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23325060 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS CUT SEVERAL TIMES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22537486 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS CUT SEVERAL TIMES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22537185 ↗
• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WE HAVE INCIDENCE OF 8/0 PROLENE SNAPPING UNDER MR B. AND MR B. CASES. I WOULD HAVE THOUGHT IF YOU CAN GAVE US A VISIT REGARDING THIS BECAUSE I HAVE OTHER QUESTIONS TOO. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395275 ↗
• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WE HAVE INCIDENCE OF 8/0 PROLENE SNAPPING UNDER MR (B)(6). AND MR (B)(6). CASES. I WOULD HAVE THOUGHT IF YOU CAN GAVE US A VISIT REGARDING THIS BECAUSE I HAVE OTHER QUESTIONS TOO. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395274 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, 4X EP8741H SUTURES BROKE WITH DR* ANASTOMOSIS IN THE CABG. THE 4 SUTURES WERE DISCARDED AND CANNOT BE RETURNED BUT THE REMAINING 5 SUTURES WERE REMOVED AND WILL BE RETURNED FOR EVALUATION. 4 OTHER SUTURES WERE OPENED AND USED TO COMPLETE THE ANASTOMOSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382796 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, 4X EP8741H SUTURES BROKE WITH DR* ANASTOMOSIS IN THE CABG. THE 4 SUTURES WERE DISCARDED AND CANNOT BE RETURNED BUT THE REMAINING 5 SUTURES WERE REMOVED AND WILL BE RETURNED FOR EVALUATION. 4 OTHER SUTURES WERE OPENED AND USED TO COMPLETE THE ANASTOMOSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382795 ↗

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-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• 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
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647

…and 6 more.