PROLENE M8710Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705031045842), received between Apr 22, 2019 and Apr 20, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 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 TO THE SALES REPRESENTATIVE THAT DURING A CABG PROCEDURE, THE NEEDLE POPPED OFF FROM THE SUTURE AT THE END OF THE SUTURE WHILE PERFORMING THE ANASTOMOSIS. NO PATIENT CONSEQUENCES WERE REPORTED. THE DEVICE IS NOT RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932292 ↗
• MalfunctionMay 26, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010266 ↗
• MalfunctionFeb 28, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC CARDIOVASCULAR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE IS FRAYING WHILE SUTURING UNKNOWN TISSUE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16453318 ↗
• MalfunctionFeb 28, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC CARDIOVASCULAR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE IS FRAYING WHILE SUTURING UNKNOWN TISSUE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16453179 ↗
• MalfunctionDec 19, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT WOUND CLOSURE PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE SURGERY. CHANGED 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 16009999 ↗
• MalfunctionDec 19, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BRAIN HERNIA PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE PROBLEM OF SUTURE PULLING OFF THE NEEDLE HAPPENED IN THE SURGERY. CHANGED 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 16008048 ↗
• MalfunctionDec 19, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BRAIN HERNIA PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE PROBLEM OF SUTURE PULLING OFF THE NEEDLE HAPPENED IN THE SURGERY. CHANGED 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 16007939 ↗
• MalfunctionApr 2, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PEDIATRIC THORACIC PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE BROKE. THE PROCEDURE WAS DELAYED BY AN UNDETERMINED AMOUNT OF TIME. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9916445 ↗
• MalfunctionApr 2, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PEDIATRIC THORACIC PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE BROKE. THE PROCEDURE WAS DELAYED BY AN UNDETERMINED AMOUNT OF TIME. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9916437 ↗
• MalfunctionApr 2, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PEDIATRIC THORACIC PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE BROKE. THE PROCEDURE WAS DELAYED BY AN UNDETERMINED AMOUNT OF TIME. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9916372 ↗
• MalfunctionApr 2, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PEDIATRIC THORACIC PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE BROKE. THE PROCEDURE WAS DELAYED BY AN UNDETERMINED AMOUNT OF TIME. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9916275 ↗
• MalfunctionApr 2, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PEDIATRIC THORACIC PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE BROKE. THE PROCEDURE WAS DELAYED BY AN UNDETERMINED AMOUNT OF TIME. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9916261 ↗
• MalfunctionApr 2, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PEDIATRIC THORACIC PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE BROKE. THE PROCEDURE WAS DELAYED BY AN UNDETERMINED AMOUNT OF TIME. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9916248 ↗
• MalfunctionApr 2, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PEDIATRIC THORACIC PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE BROKE. THE PROCEDURE WAS DELAYED BY AN UNDETERMINED AMOUNT OF TIME. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9916246 ↗
• MalfunctionFeb 7, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING SURGERY, WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THERE HAD BEEN A FOREIGN SUBSTANCE LIKE A HAIR ON THE NEEDLE PARK FOAM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9681957 ↗
• MalfunctionOct 23, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE NEEDLE WAS RELEASING TOO QUICKLY. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9224865 ↗
• MalfunctionApr 24, 2019Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIAC PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE SEPARATED FROM THE SUTURE DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO DEVICES WILL BE RETURNED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8544927 ↗
• MalfunctionApr 22, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE SEPARATED FROM THE SUTURE DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8537054 ↗

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-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-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• 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-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031

…and 6 more.