PROLENE EPM8703Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10705031203587), received between Nov 6, 2019 and Aug 8, 2025 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Break” (23 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.

• MalfunctionAug 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST REDUCTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REPS WHO WAS IN THE CASE THAT, DURING THE PROCEDURE THE SURGEON WAS TYING DOWN THE ANASTOMOSIS AND THE SUTURE SNAP IN HALF. PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749164 ↗
• MalfunctionAug 1, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL PER SALES REP THAT THE SUTURE IS BREAKING WHEN THE SURGEON IS TIEING DOWN. NO ADVERSE IMPACT PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22690190 ↗
• MalfunctionAug 1, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP, THAT DURING CABG, THREE DIFFERENT SUTURES SNAPPED AND HALF AS THE SURGEON IS TYING THEM DOWN. TWO SUTURES CAME FROM THE SAME EIGHT PACK AND ONE CAME FROM ONE OF EACH PACK . NO PATIENT CONSEQUENCES WAS REPORTED. TWO ARE AVAILABLE OF RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22689693 ↗
• MalfunctionAug 1, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP, THAT DURING CABG, THREE DIFFERENT SUTURES SNAPPED AND HALF AS THE SURGEON IS TYING THEM DOWN. TWO SUTURES CAME FROM THE SAME EIGHT PACK AND ONE CAME FROM ONE OF EACH PACK . NO PATIENT CONSEQUENCES WAS REPORTED. TWO ARE AVAILABLE OF RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22689692 ↗
• MalfunctionAug 1, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP, THAT DURING CABG, THREE DIFFERENT SUTURES SNAPPED AND HALF AS THE SURGEON IS TYING THEM DOWN. TWO SUTURES CAME FROM THE SAME EIGHT PACK AND ONE CAME FROM ONE OF EACH PACK. NO PATIENT CONSEQUENCES WAS REPORTED. TWO ARE AVAILABLE OF RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22689690 ↗
• MalfunctionJun 18, 2024Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A CABG PROCEDURE THAT THESE TWO SUTURES SEEMS TO BE VERY BRITTLE AND ARE BREAKING. THEY HAVE HAD TO WET THE SUTURE AND TIE EXTRA KNOTS. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19560086 ↗
• MalfunctionJun 18, 2024Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A CABG PROCEDURE THAT THESE TWO SUTURES SEEMS TO BE VERY BRITTLE AND ARE BREAKING. THEY HAVE HAD TO WET THE SUTURE AND TIE EXTRA KNOTS. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19560003 ↗
• MalfunctionMay 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT POPPING OFF OF THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372407 ↗
• MalfunctionApr 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT POPPING OFF OF THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19100221 ↗
• MalfunctionApr 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT POPPING OFF OF THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19100177 ↗
• MalfunctionDec 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE IN (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE POPPED OFF WHILE SUTURING VESSELS DOING THE ANASTOMOSIS. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410056 ↗
• MalfunctionAug 11, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE IN (B)(6) 2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE SALES REP THAT DURING CARDIOVASCULAR THE SURGEON REALIZED IT WAS NOT THE CORRECT SUTURE THAT HE NORMALLY PULLS. INSTEAD WHAT IN THE BOX WAS EPM8703 LOT NUMBER (SKBDHH). THEY OPENED ANOTHER BOX WITH THE CORRECT CODE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17509278 ↗
• MalfunctionAug 11, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE IN (B)(6) 2023. AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE SALES REP THAT DURING CARDIOVASCULAR THE SURGEON REALIZED IT WAS NOT THE CORRECT SUTURE THAT HE NORMALLY PULLS. INSTEAD WHAT IN THE BOX WAS EPM8703 LOT NUMBER (SKBDHH). THEY OPENED ANOTHER BOX WITH THE CORRECT CODE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17509277 ↗
• MalfunctionMar 21, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE BROKE CLOSE TO THE SWEDGE AND LOOKED LIKE A CORN HUSK. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16585265 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRIPLE BYPASS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE WHILE SUTURING THE ANASTOMOSIS ON THE HEART. SURGEON SWITCHED HIS TECHNIQUE PURSE STRING AND SUTURE TO ANOTHER LIKE DEVICE TO COMPETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13864554 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRIPLE BYPASS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE WHILE SUTURING THE ANASTOMOSIS ON THE HEART. SURGEON SWITCHED HIS TECHNIQUE PURSE STRING AND SUTURE TO ANOTHER LIKE DEVICE TO COMPETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13864518 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRIPLE BYPASS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE WHILE SUTURING THE ANASTOMOSIS ON THE HEART. SURGEON SWITCHED HIS TECHNIQUE PURSE STRING AND SUTURE TO ANOTHER LIKE DEVICE TO COMPETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13864506 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRIPLE BYPASS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE WHILE SUTURING THE ANASTOMOSIS ON THE HEART. SURGEON SWITCHED HIS TECHNIQUE PURSE STRING AND SUTURE TO ANOTHER LIKE DEVICE TO COMPETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13864478 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRIPLE BYPASS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE WHILE SUTURING THE ANASTOMOSIS ON THE HEART. SURGEON SWITCHED HIS TECHNIQUE PURSE STRING AND SUTURE TO ANOTHER LIKE DEVICE TO COMPETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13864433 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRIPLE BYPASS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE WHILE SUTURING THE ANASTOMOSIS ON THE HEART. SURGEON SWITCHED HIS TECHNIQUE PURSE STRING AND SUTURE TO ANOTHER LIKE DEVICE TO COMPETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13864428 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRIPLE BYPASS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE WHILE SUTURING THE ANASTOMOSIS ON THE HEART. SURGEON SWITCHED HIS TECHNIQUE PURSE STRING AND SUTURE TO ANOTHER LIKE DEVICE TO COMPETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13864351 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRIPLE BYPASS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE WHILE SUTURING THE ANASTOMOSIS ON THE HEART. SURGEON SWITCHED HIS TECHNIQUE PURSE STRING AND SUTURE TO ANOTHER LIKE DEVICE TO COMPETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13864335 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRIPLE BYPASS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE WHILE SUTURING THE ANASTOMOSIS ON THE HEART. SURGEON SWITCHED HIS TECHNIQUE PURSE STRING AND SUTURE TO ANOTHER LIKE DEVICE TO COMPETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13864306 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRIPLE BYPASS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURES BROKE WHILE SUTURING THE ANASTOMOSIS ON THE HEART. SURGEON SWITCHED HIS TECHNIQUE PURSE STRING AND SUTURE TO ANOTHER LIKE DEVICE TO COMPETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13864250 ↗
• MalfunctionNov 6, 2019Break; Break

  IT WAS THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE IN HALF. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9285314 ↗

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-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• 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-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995

…and 6 more.