PROLENE EPM8747Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705031203693), received between Mar 3, 2020 and Jan 23, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Material Separation” (14 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING SURGERY, THE SUTURE NEEDLE KEPT POPPING OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161615 ↗
• MalfunctionJan 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING SURGERY, THE SUTURE NEEDLE KEPT POPPING OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161569 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888728 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888725 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888722 ↗
• MalfunctionJun 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OFF-PUMP CORONARY ARTERY BYPASS GRAFTING PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. SURGERY, THE SUTURE WAS BROKEN LIKE THE SUTURE WAS DETACHED AT FIRST DURING A CORONARY ARTERY ANASTOMOSIS. ANOTHER PRODUCT WAS USED BUT IT OCCURRED TWICE IN A ROW. ANOTHER LOT OF THE PRODUCT WAS USED TO COMPLETE THE CASE. THE PRODUCT WAS USED ON THE CORONARY ARTERY. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294195 ↗
• MalfunctionJun 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OFF-PUMP CORONARY ARTERY BYPASS GRAFTING PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. SURGERY, THE SUTURE WAS BROKEN LIKE THE SUTURE WAS DETACHED AT FIRST DURING A CORONARY ARTERY ANASTOMOSIS. ANOTHER PRODUCT WAS USED BUT IT WAS OCCURRED TWICE IN A ROW. ANOTHER LOT OF THE PRODUCT WAS USED TO COMPLETE THE CASE. THE PRODUCT WAS USED ON THE CORONARY ARTERY. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294173 ↗
• MalfunctionJun 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OFF-PUMP CORONARY ARTERY BYPASS GRAFTING PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. SURGERY, THE SUTURE WAS BROKEN LIKE THE SUTURE WAS DETACHED AT FIRST DURING A CORONARY ARTERY ANASTOMOSIS. ANOTHER PRODUCT WAS USED BUT IT WAS OCCURRED TWICE IN A ROW. ANOTHER LOT OF THE PRODUCT WAS USED TO COMPLETE THE CASE. THE PRODUCT WAS USED ON THE CORONARY ARTERY. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293890 ↗
• MalfunctionAug 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS THE SAME KIND OF STRING KNOT THAT THE DOCTOR NORMALLY USE DURING VASCULAR ANASTOMOSIS, BUT IT BROKE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19966961 ↗
• MalfunctionAug 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS THE SAME KIND OF STRING KNOT THAT THE DOCTOR NORMALLY USE DURING VASCULAR ANASTOMOSIS, BUT IT BROKE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19966442 ↗
• MalfunctionOct 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE (B)(6) 2023 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004242 ↗
• MalfunctionOct 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004240 ↗
• MalfunctionJun 16, 2023Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. IT WAS REPORTED THE INSIDE OF THE STERILE PACKAGE WAS DIRTY, ALSO THE STERILE PACKAGE WAS TORN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17144178 ↗
• MalfunctionJun 3, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, WHEN PULLING THE SUTURE DURING LITA-LAD ANASTOMOSIS BY CONTINUOUS SUTURING, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10117292 ↗
• MalfunctionJun 3, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, WHEN PULLING THE SUTURE DURING LITA-LAD ANASTOMOSIS BY CONTINUOUS SUTURING, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10117289 ↗
• MalfunctionJun 3, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, WHEN PULLING THE SUTURE DURING LITA-LAD ANASTOMOSIS BY CONTINUOUS SUTURING, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10117288 ↗
• MalfunctionJun 3, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, WHEN PULLING THE SUTURE DURING LITA-LAD ANASTOMOSIS BY CONTINUOUS SUTURING, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10117286 ↗
• MalfunctionApr 20, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING VASCULAR ANASTOMOSIS BY CONTINUOUS SUTURING. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THE AFFECTED SUTURE WAS USED BY TYING THEM AT THE BREAKAGE POINT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9978401 ↗
• MalfunctionApr 20, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING VASCULAR ANASTOMOSIS BY CONTINUOUS SUTURING. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THE AFFECTED SUTURE WAS USED BY TYING THEM AT THE BREAKAGE POINT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9978400 ↗
• MalfunctionMar 3, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT ON (B)(6) 2020 AND SUTURE WAS USED. DURING CORONARY ANASTOMOSIS, THE SUTURE WAS BROKEN. THE SURGEON COMMENTED THAT THE SUTURE WAS CAUGHT ON THE BLUE COVERING CLOTH, CAUSING THE SUTURE BREAKAGE. THE NEEDLE HAD NOT FALLEN INTO THE PATIENT. THE NEEDLE COULD BE FOUND IMMEDIATELY. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9780827 ↗

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-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• 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-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844

…and 6 more.