PROLENE EP8702HRecalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10705031206793), received between Oct 12, 2022 and Aug 13, 2026 — classified as 1 injury, 55 malfunctions.

The most frequently reported specific device problem is “Break” (36 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50234851 ↗
• MalfunctionAug 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50234848 ↗
• MalfunctionApr 27, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE SEPARATED FROM THE NEEDLE DURING ANASTOMOSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001655 ↗
• MalfunctionSep 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE SNAPPED OFF DURING STITCHING ANASTOMOSIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027682 ↗
• MalfunctionSep 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE SNAPPED OFF DURING STITCHING ANASTOMOSIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027674 ↗
• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE SNAPPED WHILE SUTURING THE VEIN GRAFT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088722 ↗
• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE SNAPPED WHILE SUTURING THE VEIN GRAFT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088705 ↗
• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, ONE WAS ALREADY HOLDING AN ANASTOMOSIS OF THE VEIN GRAFT ON THE HEART AND WHEN THE SURGEON WENT TO PUT IN A REPAIR STITCH, HE DISCOVERED THE STITCH HAD BROKEN AND SURGEON HAD TO REDO THE ANASTOMOSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036398 ↗
• MalfunctionMay 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. THE SUTURE BROKE DURING ANASTOMOSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21990776 ↗
• MalfunctionMay 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. THE SUTURE BROKE DURING ANASTOMOSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21990774 ↗
• MalfunctionApr 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SECOND NEEDLE DETACHED FROM SUTURE AT THE SWAGE WHEN SURGEON ABOUT TO USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885713 ↗
• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE EVERPOINT SUTURE EP8702H BREAK DURING CABG ANASTOMOSES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872705 ↗
• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE EVERPOINT SUTURE EP8702H BREAK DURING CABG ANASTOMOSES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872704 ↗
• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE EVERPOINT SUTURE EP8702H BREAK DURING CABG ANASTOMOSES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872703 ↗
• MalfunctionApr 18, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE CV SURGEON WAS DOING ANASTOMOSIS, THE SURGEON NOTICED THE NEEDLE COATING CAME OFF FROM THE NEEDLE. THE NEEDLE WAS DISPOSED OF, AS THERE WAS SOME WHITE/YELLOWISH THING LEFT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865493 ↗
• MalfunctionJan 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, CV SURGEON ENCOUNTERED PROLENE 7-0 EVERPOINT SUTURE DETACHED FROM THE SWAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21163939 ↗
• MalfunctionDec 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT 3 PIECES OF SUTURE BREAK DURING CABG PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924694 ↗
• MalfunctionDec 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT 3 PIECES OF SUTURE BREAK DURING CABG PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924685 ↗
• MalfunctionDec 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT 3 PIECES OF SUTURE BREAK DURING CABG PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924672 ↗
• MalfunctionNov 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE SNAPPED AT THE SWAGE WHEN IT WAS PULLED AFTER THE FIRST PASS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20602100 ↗
• MalfunctionOct 28, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A CABG PROCEDURE, DOCTOR STATED THAT WHILE USING THE SUTURE, THE NEEDLE POPPED OFF THE SUTURE. OPENED ANOTHER SUTURE AND THAT ONE HAD A KINK IN IT. DID NOT REALIZE THERE WAS A KINK IN IT UNTIL USING IT AND NOTICED IT WAS NOT AS SMOOTH. OPENED A THIRD SUTURE TO COMPLETE CASE. NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20546637 ↗
• MalfunctionOct 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE CV SURGEON EXPERIENCED SUTURE DETACHED FROM SWAGE WHEN HE IS PERFORMING DISTAL ANASTOMOSIS DURING CABG PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385778 ↗
• MalfunctionOct 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE CV SURGEON EXPERIENCED SUTURE DETACHED FROM SWAGE WHEN HE IS PERFORMING DISTAL ANASTOMOSIS DURING CABG PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385773 ↗
• MalfunctionSep 19, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE SNAP IN THE MIDDLE OF TYING WHEN CV SURGEON IS DOING CABG DISTAL ANASTOMOSIS. THE SUTURE IS NOT SNAPPING FROM THE SWAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258516 ↗
• MalfunctionSep 16, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. IT WAS REPORTED THAT TWO NEEDLE SUTURE DETACHED AND BROKE DURING PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226104 ↗

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-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-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• 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-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995

…and 6 more.