PROLENE EPM8751Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705031206861), received between Nov 23, 2021 and Jan 28, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 24199067 ↗
• MalfunctionOct 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE SURGEON TO THE SALES REP THAT DURING CABG PROCEDURE, THE SURGEON WAS EXPERIENCING AN ISSUE WITH THE NEEDLE DRAGGING AT THE SWAGE. NO PATIENT CONSEQUENCES WERE REPORTED. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368270 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT, THE THREE DIFFERENT STRAND OF SUTURE BROKE AS THE SURGEON TYING DOWN THE ANASTOMOSIS. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT RETURN IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303767 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT, THE THREE DIFFERENT STRAND OF SUTURE BROKE AS THE SURGEON TYING DOWN THE ANASTOMOSIS. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT RETURN IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303489 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT, THE THREE DIFFERENT STRAND OF SUTURE BROKE AS THE SURGEON TYING DOWN THE ANASTOMOSIS. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT RETURN IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303008 ↗
• MalfunctionAug 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE WAS POPPING OFF THE THREAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715021 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SURGEON PASSED THE 7-0 PROLENE THROUGH THE TISSUE AND THE STRAND BROKE. SURGEON SAID IT FELT LIKE IT DISINTEGRATED IN HIS HANDS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22667285 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A CARDIOVASCULAR PROCEDURE, THE SUTURE KEEPS ON BREAKING MULTIPLE TIMES. THE SURGEON USED ANOTHER PRODUCT CODE TO PROCEED WITH THE PROCEDURE. EXACT DEVICE IS NOT RETURNING BUT THE OTHERS ON THE SAME BOX WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647905 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A CARDIOVASCULAR PROCEDURE, THE SUTURE KEEPS ON BREAKING MULTIPLE TIMES. THE SURGEON USED ANOTHER PRODUCT CODE TO PROCEED WITH THE PROCEDURE. EXACT DEVICE IS NOT RETURNING BUT THE OTHERS ON THE SAME BOX WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647879 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A CARDIOVASCULAR PROCEDURE, THE SUTURE KEEPS ON BREAKING MULTIPLE TIMES. THE SURGEON USED ANOTHER PRODUCT CODE TO PROCEED WITH THE PROCEDURE. EXACT DEVICE IS NOT RETURNING BUT THE OTHERS ON THE SAME BOX WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22646865 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A CARDIOVASCULAR PROCEDURE, THE SUTURE KEEPS ON BREAKING MULTIPLE TIMES. THE SURGEON USED ANOTHER PRODUCT CODE TO PROCEED WITH THE PROCEDURE. EXACT DEVICE IS NOT RETURNING BUT THE OTHERS ON THE SAME BOX WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22646859 ↗
• MalfunctionOct 25, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURE WAS BREAKING AND NEEDLE WAS POPPING OFF. PATIENT CONSEQUENCES UNKNOWN. SURGICAL DELAY UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20537937 ↗
• MalfunctionOct 25, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURE WAS BREAKING AND NEEDLE WAS POPPING OFF. PATIENT CONSEQUENCES UNKNOWN. SURGICAL DELAY UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20536496 ↗
• MalfunctionOct 25, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURE WAS BREAKING AND NEEDLE WAS POPPING OFF. PATIENT CONSEQUENCES UNKNOWN. SURGICAL DELAY UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20536258 ↗
• MalfunctionNov 10, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT THE SUTURES KEPT BREAKING. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18111706 ↗
• MalfunctionJun 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN HEART PROCEDURE ON AN UNKNOWN DATE IN 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14691427 ↗
• MalfunctionJun 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN HEART PROCEDURE ON AN UNKNOWN DATE IN 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14691416 ↗
• MalfunctionJun 14, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN HEART PROCEDURE ON AN UNKNOWN DATE IN 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14691357 ↗
• MalfunctionJun 14, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN HEART PROCEDURE ON AN UNKNOWN DATE IN 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14691338 ↗
• MalfunctionNov 23, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY BYPASS GRAFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A DISTAL ANASTOMOSIS, THE SUTURE CAME OFF OF THE NEEDLE AT THE SWAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866746 ↗

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-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• 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-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• 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-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• 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

…and 6 more.