PROLENE EPM8706Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705031206854), received between Jul 27, 2021 and Jan 28, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING A CABG, THE SURGEON STATED TWO 6-0, AND ONE 7-0 SUTURES POPPED OFF WHEN SUTURING THROUGH VESSELS WITHIN SAME CASE. SURGEON SAID HE THINKS ITS A BAD BATCH AS THIS USUALLY HAPPENS ONCE BUT NOT 3 TIMES BACK-TO-BACK TO BACK. THEY WERE ABLE TO FINISH CASE WITH NO PROBLEMS AND PATIENT IS FINE. THEY OPENED A NEW LOT FOR BOTH CODES TO FINISH CASE. THERE WAS NO SIGNIFICANT DELAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199052 ↗
• MalfunctionJan 28, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING A CABG, THE SURGEON STATED TWO 6-0, AND ONE 7-0 SUTURES POPPED OFF WHEN SUTURING THROUGH VESSELS WITHIN SAME CASE. SURGEON SAID HE THINKS ITS A BAD BATCH AS THIS USUALLY HAPPENS ONCE BUT NOT 3 TIMES BACK TO BACK TO BACK. THEY WERE ABLE TO FINISH CASE WITH NO PROBLEMS AND PATIENT IS FINE. THEY OPENED A NEW LOT FOR BOTH CODES TO FINISH CASE. THERE WAS NO SIGNIFICANT DELAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199051 ↗
• MalfunctionJul 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT, THE NEEDLE WAS COMING OFF THE SUTURE. TWO PRODUCT IS AVAILABLE FOR RETURN FOR EVALUATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554698 ↗
• MalfunctionJul 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT, THE NEEDLE WAS COMING OFF THE SUTURE. TWO PRODUCT IS AVAILABLE FOR RETURN FOR EVALUATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554696 ↗
• MalfunctionApr 19, 2024Material Frayed; Material Frayed

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19145127 ↗
• MalfunctionDec 7, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN TRYING TO TIE THE SUTURE, IT BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15934074 ↗
• MalfunctionDec 7, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN TRYING TO TIE THE SUTURE, IT BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15933982 ↗
• MalfunctionDec 7, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN TRYING TO TIE THE SUTURE, IT BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15933970 ↗
• MalfunctionSep 16, 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 WAS BREAKING. UNKNOWN AS TO WHAT TYPE OF TISSUE WAS BEING SUTURED AT THE TIME. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15439975 ↗
• MalfunctionNov 8, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT OVER THE LAST YEAR DURING UNKNOWN HEART PROCEDURES THAT THE SUTURE KEEPS BREAKING WHILE TYING. UNKNOWN AS TO EXACTLY HOW MANY TIMES THIS HAS HAPPENED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775105 ↗
• MalfunctionSep 28, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE VESSEL ANASTOMOSIS, THE SUTURE BROKE WHEN TYING. SURGERY WAS COMPLETED DURING THE ORIGINAL PROCEDURE BUT DELAYED PROCEDURE BY AT LEAST 15 MIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12543878 ↗
• MalfunctionSep 28, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE VESSEL ANASTOMOSIS, THE SUTURE BROKE WHEN TYING. SURGERY WAS COMPLETED DURING THE ORIGINAL PROCEDURE BUT DELAYED PROCEDURE BY AT LEAST 15 MIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12543869 ↗
• MalfunctionJul 27, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN TYING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12232153 ↗
• MalfunctionJul 27, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN TYING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12232127 ↗
• MalfunctionJul 27, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN TYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230032 ↗
• MalfunctionJul 27, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN TYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230026 ↗
• MalfunctionJul 27, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN TYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230017 ↗
• MalfunctionJul 27, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN TYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230011 ↗
• MalfunctionJul 27, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN TYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229995 ↗
• MalfunctionJul 27, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN TYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229979 ↗

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-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844

…and 6 more.