PROLENE M8709Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10705031045835), received between Apr 17, 2019 and Jun 27, 2025 — classified as 4 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TETRALOGY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A TETRALOGY OF FALLOT PROCEDURE, THE SUTURE WOULD EASILY SNAP OFF FROM THE NEEDLE WHILE IN USE OR THE SUTURE WOULD EASILY BREAK. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22347360 ↗
• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TETRALOGY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A TETRALOGY OF FALLOT PROCEDURE, THE SUTURE WOULD EASILY SNAP OFF FROM THE NEEDLE WHILE IN USE OR THE SUTURE WOULD EASILY BREAK. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22347356 ↗
• MalfunctionDec 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PREMATURELY POPPED OFF. THE NEEDLE WAS RETRIEVED AND THERE WAS NO PATIENT HARM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20921583 ↗
• MalfunctionDec 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PREMATURELY POPPED OFF. THE NEEDLE WAS RETRIEVED AND THERE WAS NO PATIENT HARM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20920986 ↗
• MalfunctionDec 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PREMATURELY POPPED OFF. THE NEEDLE WAS RETRIEVED AND THERE WAS NO PATIENT HARM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20918138 ↗
• MalfunctionJan 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS EASILY DETACHED FROM THE SUTURE. 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 18489195 ↗
• MalfunctionJun 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ANEURYSM PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE CUSTOMER THAT DURING AN AORTIC ANEURYSM PROCEDURE THAT WHEN TYING THE ANASTOMOSIS, THE NEEDLE POPPED OFF WITH MINIMAL EFFORT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067132 ↗
• MalfunctionJun 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ANEURYSM PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE CUSTOMER THAT DURING AN AORTIC ANEURYSM PROCEDURE THAT WHEN TYING THE ANASTOMOSIS, THE NEEDLE POPPED OFF WITH MINIMAL EFFORT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17066487 ↗
• MalfunctionJun 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ANEURYSM PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE CUSTOMER THAT DURING AN AORTIC ANEURYSM PROCEDURE THAT WHEN TYING THE ANASTOMOSIS, THE NEEDLE POPPED OFF WITH MINIMAL EFFORT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17066363 ↗
• MalfunctionMar 24, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN VASCULAR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE BROKE IN USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO REPORTED ADVERSE CONSEQUENCE TO PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16609104 ↗
• MalfunctionMar 24, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN VASCULAR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE BROKE IN USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO REPORTED ADVERSE CONSEQUENCE TO PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16609103 ↗
• MalfunctionFeb 7, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL VENTRICULAR SEPTAL DEFECT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE SNAPPED OFF THE SUTURE. ANOTHER DEVICE OF SAME LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16310634 ↗
• MalfunctionFeb 7, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL VENTRICULAR SEPTAL DEFECT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE SNAPPED OFF THE SUTURE. ANOTHER DEVICE OF SAME LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16310630 ↗
• MalfunctionOct 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTA FEMORAL BYPASS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE DEVICE WAS BREAKING A PART. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15601021 ↗
• MalfunctionSep 7, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN VASCULAR PROCEDURE ON (B)(6) 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE NEEDLE WAS POPPING OFF OF THE SUTURE AS THE SURGEON WAS PULLING IT THROUGH THE TISSUE. THEY WOULD START AND THE NEEDLE WOULD POP OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375262 ↗
• MalfunctionFeb 16, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IN MID STITCH, A PROLENE NEEDLE SEPARATED FROM THE SUTURE. THE NEEDLE WAS DROPPED AND NEVER RECOVERED, DESPITE EXTENSIVELY SEARCHING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13546012 ↗
• MalfunctionDec 17, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT IS UNKNOWN WHERE THE SUTURES WERE BREAKING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13031950 ↗
• MalfunctionNov 8, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AV GRAFT CREATION ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MID STRAND ON THE FIRST PASS. A NEW SUTURE WAS USED TO COMPLETE THE CASE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770102 ↗
• InjuryOct 1, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A FEMORAL TIBIAL BYPASS PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED TO SUTURE VASCULAR TISSUE. DURING THE PROCEDURE, THE SUTURE WAS BREAKING MID STRAND WHILE SUTURING VASCULAR TISSUE. SOME OF THE SUTURES BROKE WHEN THE RUBBER SHOD WAS BEING APPLIED TO THE SUTURE. ANOTHER LIKE DEVICE OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. PATIENT EXPERIENCED EXCESSIVE BLEEDING REQUIRING TWO UNITS OF BLOOD. ANY ADDITIONAL CONSEQUENCES ARE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12563976 ↗
• InjuryOct 1, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A FEMORAL TIBIAL BYPASS PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED TO SUTURE VASCULAR TISSUE. DURING THE PROCEDURE, THE SUTURE WAS BREAKING MID STRAND WHILE SUTURING VASCULAR TISSUE. SOME OF THE SUTURES BROKE WHEN THE RUBBER SHOD WAS BEING APPLIED TO THE SUTURE. ANOTHER LIKE DEVICE OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. PATIENT EXPERIENCED EXCESSIVE BLEEDING REQUIRING TWO UNITS OF BLOOD. ANY ADDITIONAL CONSEQUENCES ARE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12563437 ↗
• InjuryOct 1, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A FEMORAL TIBIAL BYPASS PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED TO SUTURE VASCULAR TISSUE. DURING THE PROCEDURE, THE SUTURE WAS BREAKING MID STRAND WHILE SUTURING VASCULAR TISSUE. SOME OF THE SUTURES BROKE WHEN THE RUBBER SHOD WAS BEING APPLIED TO THE SUTURE. ANOTHER LIKE DEVICE OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. PATIENT EXPERIENCED EXCESSIVE BLEEDING REQUIRING TWO UNITS OF BLOOD. ANY ADDITIONAL CONSEQUENCES ARE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12563234 ↗
• InjuryOct 1, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A FEMORAL TIBIAL BYPASS PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED TO SUTURE VASCULAR TISSUE. DURING THE PROCEDURE, THE SUTURE WAS BREAKING MID STRAND WHILE SUTURING VASCULAR TISSUE. SOME OF THE SUTURES BROKE WHEN THE RUBBER SHOD WAS BEING APPLIED TO THE SUTURE. ANOTHER LIKE DEVICE OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. PATIENT EXPERIENCED EXCESSIVE BLEEDING REQUIRING TWO UNITS OF BLOOD. ANY ADDITIONAL CONSEQUENCES ARE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12563212 ↗
• MalfunctionFeb 18, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAROTID PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE FRAYED AND PIGTAILED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345975 ↗
• MalfunctionFeb 18, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAROTID PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE BROKE AND PATIENT HAD TO BE RECLAMPED AND CAROTID PATCH REDONE WITH DIFFERENT SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345969 ↗
• MalfunctionFeb 18, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAROTID PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE BROKE AND PATIENT HAD TO BE RECLAMPED AND CAROTID PATCH REDONE WITH DIFFERENT SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345905 ↗

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-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-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• 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-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-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• 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-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995

…and 6 more.