PROLENE EP8740HRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10705031206694), received between Jun 18, 2019 and Jul 24, 2023 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Material Separation” (13 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURE. THE PRODUCT WAS USED ON BLOOD VESSEL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17383862 ↗
• MalfunctionJul 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURE. THE PRODUCT WAS USED ON BLOOD VESSEL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17383427 ↗
• MalfunctionJul 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURE. THE PRODUCT WAS USED ON BLOOD VESSEL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17383405 ↗
• MalfunctionJun 19, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURE. THIS HAPPENED IN 4 PRODUCTS. ALL THE PLACES WHERE THE SUTURES WERE BROKEN WERE IN SIMILAR POSITIONS. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THE PRODUCTS WERE USED ON MAINLY ITA-LAD. THE SALES REP GOT ONLY 1 COMPLAINT PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159954 ↗
• MalfunctionJun 19, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURE. THIS HAPPENED IN 4 PRODUCTS. ALL THE PLACES WHERE THE SUTURES WERE BROKEN WERE IN SIMILAR POSITIONS. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THE PRODUCTS WERE USED ON MAINLY ITA-LAD. THE SALES REP GOT ONLY 1 COMPLAINT PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159953 ↗
• MalfunctionJun 19, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURE. THIS HAPPENED IN 4 PRODUCTS. ALL THE PLACES WHERE THE SUTURES WERE BROKEN WERE IN SIMILAR POSITIONS. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THE PRODUCTS WERE USED ON MAINLY ITA-LAD. THE SALES REP GOT ONLY 1 COMPLAINT PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159952 ↗
• MalfunctionJun 19, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURE. THIS HAPPENED IN 4 PRODUCTS. ALL THE PLACES WHERE THE SUTURES WERE BROKEN WERE IN SIMILAR POSITIONS. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THE PRODUCTS WERE USED ON MAINLY ITA-LAD. THE SALES REP GOT ONLY 1 COMPLAINT PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159951 ↗
• MalfunctionDec 5, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING CONTINUOUS SUTURING. THIS HAPPENED IN MANY NEEDLE-SUTURES. IT WAS HARD TO SUTURE SO SEVERAL NEEDLE-SUTURES WERE USED. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921591 ↗
• MalfunctionDec 5, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING CONTINUOUS SUTURING. THIS HAPPENED IN MANY NEEDLE-SUTURES. IT WAS HARD TO SUTURE SO SEVERAL NEEDLE-SUTURES WERE USED. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921590 ↗
• MalfunctionDec 5, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING CONTINUOUS SUTURING. THIS HAPPENED IN MANY NEEDLE-SUTURES. IT WAS HARD TO SUTURE SO SEVERAL NEEDLE-SUTURES WERE USED. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921588 ↗
• MalfunctionDec 5, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING CONTINUOUS SUTURING. THIS HAPPENED IN MANY NEEDLE-SUTURES. IT WAS HARD TO SUTURE SO SEVERAL NEEDLE-SUTURES WERE USED. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921549 ↗
• MalfunctionDec 5, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING CONTINUOUS SUTURING. THIS HAPPENED IN MANY NEEDLE-SUTURES. IT WAS HARD TO SUTURE SO SEVERAL NEEDLE-SUTURES WERE USED. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921548 ↗
• MalfunctionDec 5, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING CONTINUOUS SUTURING. THIS HAPPENED IN MANY NEEDLE-SUTURES. IT WAS HARD TO SUTURE SO SEVERAL NEEDLE-SUTURES WERE USED. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921547 ↗
• MalfunctionDec 5, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING CONTINUOUS SUTURING. THIS HAPPENED IN MANY NEEDLE-SUTURES. IT WAS HARD TO SUTURE SO SEVERAL NEEDLE-SUTURES WERE USED. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921297 ↗
• MalfunctionDec 5, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING CONTINUOUS SUTURING. THIS HAPPENED IN MANY NEEDLE-SUTURES. IT WAS HARD TO SUTURE SO SEVERAL NEEDLE-SUTURES WERE USED. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921295 ↗
• MalfunctionDec 5, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING CONTINUOUS SUTURING. THIS HAPPENED IN MANY NEEDLE-SUTURES. IT WAS HARD TO SUTURE SO SEVERAL NEEDLE-SUTURES WERE USED. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921293 ↗
• MalfunctionDec 5, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING CONTINUOUS SUTURING. THIS HAPPENED IN MANY NEEDLE-SUTURES. IT WAS HARD TO SUTURE SO SEVERAL NEEDLE-SUTURES WERE USED. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921290 ↗
• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. SEVERAL PACKAGES WERE OPENED, BUT SEVERAL SUTURES WERE BROKEN IN AN AREA NOT RELATED TO THE ANASTOMOSIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12845315 ↗
• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. SEVERAL PACKAGES WERE OPENED, BUT SEVERAL SUTURES WERE BROKEN IN AN AREA NOT RELATED TO THE ANASTOMOSIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12845302 ↗
• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. SEVERAL PACKAGES WERE OPENED, BUT SEVERAL SUTURES WERE BROKEN IN AN AREA NOT RELATED TO THE ANASTOMOSIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12845297 ↗
• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. SEVERAL PACKAGES WERE OPENED, BUT SEVERAL SUTURES WERE BROKEN IN AN AREA NOT RELATED TO THE ANASTOMOSIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12845290 ↗
• MalfunctionAug 27, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE IN 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE SEPARATED FROM THE SUTURE DURING TISSUE PASSAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10460153 ↗
• MalfunctionJun 18, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE DURING VASCULAR ANASTOMOSIS FOR THE LIT-LAD BY CONTINUOUS SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8708646 ↗
• MalfunctionJun 18, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE DURING VASCULAR ANASTOMOSIS FOR THE LIT-LAD BY CONTINUOUS SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8708597 ↗

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-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• 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-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• 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-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631

…and 6 more.