PROLENE EPM8731Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705031203631), received between Sep 19, 2019 and May 26, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Separation” (10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, ONE OF TWO NEEDLES POPPED OFF. THIS ISSUE REPORTEDLY OCCURRED MULTIPLE TIMES WITH DEVICES, BUT THEY DON'T KNOW THE DATES THAT HAPPEN FROM THE SAME LOT NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25284042 ↗
• MalfunctionMay 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING A PROCEDURE, ONE OF TWO NEEDLES POPPED OFF. THIS ISSUE REPORTEDLY OCCURRED MULTIPLE TIMES WITH DEVICES BUT THEY DON'T KNOW THE DATES THAT HAPPEN FROM THE SAME LOT NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25281836 ↗
• MalfunctionMay 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SURGEON TO THE SALES REP THAT DURING THE CABG PROCEDURE, THE SURGEON REPORTED THAT THE NEEDLE POPPED OFF FROM THE SUTURE IN THE MIDDLE OF HIS ANASTOMOSIS. HE COULDN'T FINISH THE ANASTOMOSIS WITH THIS SUTURE AS HE HAVE TO OPEN ANOTHER SUTURES TO COMPLETE IT. NO PATIENT CONSEQUENCES. DEVICE WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163036 ↗
• MalfunctionJul 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OUT OF THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518935 ↗
• MalfunctionJul 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OUT OF THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518933 ↗
• MalfunctionApr 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A CABG, THE NEEDLE ON THE SUTURE POPPED OFF DURING THE ANASTOMOSIS. CASE WAS COMPLETED WITH A NEW STITCH TIED TO THE LAST. A DIFFERENT LOT NUMBER WAS USED. NO PATIENT HARM WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773019 ↗
• MalfunctionMay 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON WAS SEWING THE DISTAL ANASTOMOSIS THE NEEDLE OF THE SUTURE POPPED OFF. CASE WAS COMPLETED WITH LIKE DEVICE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19423838 ↗
• MalfunctionApr 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CABG (CORONARY ARTERY BYPASS GRAFT) PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. THE NEEDLE POPPED OFF ON THE DISTAL ANASTOMOSIS IN THE PROCEDURE. THEY WERE ABLE TO RETRIEVE THE NEEDLE AND PROCEED WITH THE CASE WITH A NEW SUTURE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19162543 ↗
• MalfunctionApr 19, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT MULTIPLE PATIENTS UNDERWENT CABG PROCEDURES ON UNKNOWN DATES IN 2024, AND SUTURE WAS USED. DURING THESE PROCEDURES, WHILE SUTURING THE ANASTOMOSIS, THE NEEDLE POPPED OFF. ANOTHER LIKE DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142706 ↗
• MalfunctionApr 16, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. WHILE SEWING THE DISTAL ANASTOMOSIS, THE NEEDLE POPPED OFF. ANOTHER LIKE DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19115992 ↗
• MalfunctionMar 26, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIAC PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING A SURGERY, THE SUTURE KEPT BREAKING. THE PROCEDURE WAS COMPLETED USING ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9886255 ↗
• MalfunctionMar 26, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIAC PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING A SURGERY, THE SUTURE KEPT BREAKING. THE PROCEDURE WAS COMPLETED USING ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9886223 ↗
• MalfunctionMar 26, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIAC PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING A SURGERY, THE SUTURE KEPT BREAKING. THE PROCEDURE WAS COMPLETED USING ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9886200 ↗
• MalfunctionMar 26, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIAC PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING A SURGERY, THE SUTURE KEPT BREAKING. THE PROCEDURE WAS COMPLETED USING ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9886194 ↗
• MalfunctionSep 19, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE NOT AT THE NEEDLE BUT AT THE BODY OF THE SUTURE WHILE THE SURGEON WAS TYING IT. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9090208 ↗

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-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• 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-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• 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

…and 6 more.