PROLENE M8304Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031045644), received between Aug 21, 2019 and Jan 11, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE NEEDLE PULLED AWAY FROM THE SUTURE STRAND WHEN THE SURGEON WAS APPROXIMATING TO DO ANASTOMOSIS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499910 ↗
• MalfunctionFeb 1, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE NEEDLE WAS BROKEN DURING USE, AND NO PIECES WERE LEFT INSIDE THE PATIENT. 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 11263954 ↗
• MalfunctionAug 21, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAPH ON (B)(6) 2019 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT POPPING OFF THE NEEDLE AT THE SWAGE. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE ARE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8919204 ↗
• MalfunctionAug 21, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAPH ON (B)(6) 2019 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT POPPING OFF THE NEEDLE AT THE SWAGE. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE ARE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8919199 ↗

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-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• 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-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-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688

…and 6 more.