PROLENE EPM8743Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10705031206748), received between Oct 8, 2019 and Jan 12, 2026 — classified as 32 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Material Separation; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035996 ↗
• MalfunctionNov 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE SURGICAL SUTURE, THE NEEDLE FELL OFF AND FELL INTO THE PATIENT'S BODY. FINALLY, THE COMPLETE NEEDLE BODY WAS FOUND IN THE EXTRACORPOREAL CIRCULATION MACHINE'S STORAGE VESSEL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23543678 ↗
• MalfunctionSep 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A CORONARY ARTERY BYPASS GRAFTING (CABG) THE NEEDLES WERE POPPING OFF. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. STERILE SAMPLES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057305 ↗
• MalfunctionSep 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. DURING A CORONARY ARTERY BYPASS GRAFTING (CABG) THE NEEDLES WERE POPPING OFF. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. STERILE SAMPLES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057204 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART BYPASS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE 1 ACTUAL SAMPLE WAS DISCARD. THE SURGEON REFUSED TO USE THE REMAINING 9 STERILE PRODUCTS FROM THE SAME LOT AND THEY WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508446 ↗
• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20272647 ↗
• MalfunctionSep 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING A CORONARY ARTERY BYPASS GRAFTING: CABG, DURING SURGERY, WHEN ONE END OF A DOUBLE-ENDED NEEDLE WAS GRIPPED BY A NEEDLE HOLDER AND THE OTHER END BY A RUBBERIZED MOSQUITO, THE SUTURE OF THE ONE GRIPPED BY THE MOSQUITO WAS BROKEN AND THE NEEDLE WENT SOMEWHERE ELSE. IT WAS NOT A CONTROL RELEASE NEEDLE. THE PRODUCT WAS USED ON THE PART OF VASCULAR ANASTOMOSIS. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20153149 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFTING: CABG ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN ONE OF A DOUBLE-ENDED NEEDLE WAS GRASPED WITH A NEEDLE HOLDER AND THE OTHER ONE WAS GRASPED WITH A MOSQUITO WHICH WAS ATTACHED A RUBBER, IT WAS IN A POCKET ATTACHED TO THE SIDE OF THE OPERATING TABLE, AND THE SUTURE HAD BROKEN AT THE TIMING OF TAKING IT OUT. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973187 ↗
• MalfunctionFeb 28, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFTING (CABG) ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING CONTINUOUS SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THIS HAPPENED IN TWO PRODUCTS. THE PRODUCTS WERE USED FOR VASCULAR ANASTOMOSIS. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796845 ↗
• MalfunctionFeb 28, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFTING (CABG) ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING CONTINUOUS SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THIS HAPPENED IN TWO PRODUCTS. THE PRODUCTS WERE USED FOR VASCULAR ANASTOMOSIS. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796844 ↗
• MalfunctionFeb 16, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING VASCULAR SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720143 ↗
• MalfunctionFeb 16, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING VASCULAR SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720141 ↗
• MalfunctionJan 19, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING CONTINUOUS SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18546158 ↗
• MalfunctionNov 22, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 10/31/2023, AND SUTURE WAS USED. THE PRIMARY PACKAGE WAS FOUND DAMAGED PRIOR TO PLANNED USE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18192310 ↗
• MalfunctionDec 22, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OFF PUMP CORONARY ARTERY BYPASS GRAFTING PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING IN SURGERY, CAUSING THE PATIENT'S CORONARY ANASTOMOSIS OOZING. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16038347 ↗
• MalfunctionApr 1, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART BYPASS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AFTER SEWING THE INTERNAL MAMMARY ARTERY ANTERIOR DESCENDING BRANCH FOR THE THIRD STITCH DURING THE HEART BYPASS SURGERY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13979632 ↗
• MalfunctionFeb 23, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13586417 ↗
• MalfunctionFeb 23, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13586411 ↗
• MalfunctionAug 26, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIAC PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF OF THE NEEDLE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12369684 ↗
• MalfunctionAug 23, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCARDIAC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE USER EXPERIENCED THE PROBLEM OF THE SUTURE NEEDLE PULL OFF, DURING THE PROCEDURE. THEY CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353051 ↗
• MalfunctionMay 10, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A CORONARY BYPASS GRAFTS SEVERAL SUTURES BROKE IN THE MIDDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11798820 ↗
• MalfunctionMar 12, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11477861 ↗
• MalfunctionMar 12, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11477846 ↗
• MalfunctionMar 12, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11477836 ↗
• MalfunctionFeb 25, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11379894 ↗

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-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292

…and 6 more.