PROLENE EP8703HRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10705031206830), received between Aug 25, 2022 and Apr 23, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC BYPASS PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING THE CARDIAC BYPASS PROCEDURE, THE NEEDLES WERE POPPING OFF ACROSS APPROXIMATELY SIX PACKS CONSECUTIVELY. NO PATIENT CONSEQUENCES WERE REPORTED. THE DEVICE IS RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967290 ↗
• MalfunctionApr 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC BYPASS PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING THE CARDIAC BYPASS PROCEDURE, THE NEEDLES WERE POPPING OFF ACROSS APPROXIMATELY SIX PACKS CONSECUTIVELY. NO PATIENT CONSEQUENCES WERE REPORTED. THE DEVICE IS RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967288 ↗
• MalfunctionApr 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC BYPASS PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING THE CARDIAC BYPASS PROCEDURE, THE NEEDLES WERE POPPING OFF ACROSS APPROXIMATELY SIX PACKS CONSECUTIVELY. NO PATIENT CONSEQUENCES WERE REPORTED. THE DEVICE IS RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967287 ↗
• MalfunctionApr 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC BYPASS PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING THE CARDIAC BYPASS PROCEDURE, THE NEEDLES WERE POPPING OFF ACROSS APPROXIMATELY SIX PACKS CONSECUTIVELY. NO PATIENT CONSEQUENCES WERE REPORTED. THE DEVICE IS RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967286 ↗
• MalfunctionApr 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC BYPASS PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING THE CARDIAC BYPASS PROCEDURE, THE NEEDLES WERE POPPING OFF ACROSS APPROXIMATELY SIX PACKS CONSECUTIVELY. NO PATIENT CONSEQUENCES WERE REPORTED. THE DEVICE IS RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966402 ↗
• MalfunctionMar 6, 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, NEEDLE PULL-OFF DURING TISSUE PASSAGE (VESSEL) WITHOUT STRONG PULL. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. PROCEDURE FINISHED WITH SAME AS DEVICE. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21541072 ↗
• MalfunctionMar 6, 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, NEEDLE PULL-OFF DURING TISSUE PASSAGE (VESSEL) WITHOUT STRONG PULL. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. PROCEDURE FINISHED WITH SAME LIKE DEVICE. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21541060 ↗
• MalfunctionMar 6, 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, NEEDLE PULL-OFF DURING TISSUE PASSAGE (VESSEL) WITHOUT STRONG PULL. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. PROCEDURE FINISHED WITH SAME LIKE DEVICE. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21541058 ↗
• MalfunctionMar 6, 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, NEEDLE PULL-OFF DURING TISSUE PASSAGE (VESSEL) WITHOUT STRONG PULL. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. PROCEDURE FINISHED WITH SAME LIKE DEVICE. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21541057 ↗
• MalfunctionOct 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT ON (B)(6) 2023 AND SUTURE WAS USED FOR THE ANASTOMOSIS. DURING THE PROCEDURE, THE NEEDLE PULLED OFF. IT WAS STATED THAT THERE WERE TEMPORARY CONSEQUENCES ON THE PATIENT AS THERE WAS AN EXTENSION OF THE DURATION OF THE INTERVENTION. FOR THE SURGEON TO START THE ANASTOMOSIS AGAIN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17975188 ↗
• MalfunctionOct 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17975167 ↗
• MalfunctionApr 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROSTHESIS PELVIS/KNEE PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER COMPLAIN THAT THE THREADS SPLIT OPEN SIMILAR TO HAIR AND THEREBY OFTEN BREAK DIRECTLY AFTER THE FIRST STITCH. PROCEDURE FINISHED WITH SAME LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16794551 ↗
• MalfunctionApr 17, 2023Break; Break

  THE CUSTOMER COMPLAIN THAT THE THREADS SPLIT OPEN SIMILAR TO HAIR AND THEREBY OFTEN BREAK DIRECTLY AFTER REMOVAL FROM THE PACKAGE OR AFTER THE FIRST STITCH NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. PROCEDURE FINISHED WITH SAME LIKE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16755991 ↗
• MalfunctionApr 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROSTHESIS PELVIS/KNEE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER COMPLAIN THAT THE THREADS SPLIT OPEN SIMILAR TO HAIR AND THEREBY OFTEN BREAK DIRECTLY AFTER THE FIRST STITCH. PROCEDURE FINISHED WITH SAME LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16755988 ↗
• MalfunctionApr 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROSTHESIS PELVIS/KNEE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER COMPLAIN THAT THE THREADS SPLIT OPEN SIMILAR TO HAIR AND THEREBY OFTEN BREAK DIRECTLY AFTER THE FIRST STITCH. PROCEDURE FINISHED WITH SAME LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16755985 ↗
• MalfunctionApr 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROSTHESIS PELVIS/KNEE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER COMPLAIN THAT THE THREADS SPLIT OPEN SIMILAR TO HAIR AND THEREBY OFTEN BREAK DIRECTLY AFTER THE FIRST STITCH. PROCEDURE FINISHED WITH SAME LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16755982 ↗
• MalfunctionApr 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROSTHESIS PELVIS/KNEE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER COMPLAIN THAT THE THREADS SPLIT OPEN SIMILAR TO HAIR AND THEREBY OFTEN BREAK DIRECTLY AFTER THE FIRST STITCH. PROCEDURE FINISHED WITH SAME LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16755972 ↗
• MalfunctionApr 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROSTHESIS PELVIS/KNEE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER COMPLAIN THAT THE THREADS SPLIT OPEN SIMILAR TO HAIR AND THEREBY OFTEN BREAK DIRECTLY AFTER THE FIRST STITCH. PROCEDURE FINISHED WITH SAME LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16755971 ↗
• MalfunctionApr 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROSTHESIS PELVIS/KNEE PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER COMPLAIN THAT THE THREADS SPLIT OPEN SIMILAR TO HAIR AND THEREBY OFTEN BREAK DIRECTLY AFTER THE FIRST STITCH. PROCEDURE FINISHED WITH SAME LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16755970 ↗
• MalfunctionApr 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROSTHESIS PELVIS/KNEE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER COMPLAIN THAT THE THREADS SPLIT OPEN SIMILAR TO HAIR AND THEREBY OFTEN BREAK DIRECTLY AFTER THE FIRST STITCH. PROCEDURE FINISHED WITH SAME LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16755968 ↗
• MalfunctionApr 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROSTHESIS PELVIS/KNEE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER COMPLAIN THAT THE THREADS SPLIT OPEN SIMILAR TO HAIR AND THEREBY OFTEN BREAK DIRECTLY AFTER THE FIRST STITCH. PROCEDURE FINISHED WITH SAME LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16755967 ↗
• MalfunctionAug 25, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS TORN DURING BYPASS PROCEDURE (VESSEL WALL), AFTER 1ST - 2ND KNOT (1-2 TISSUE PASSAGES). IN RELATION TO THE NEEDLE, THE SUTURE TORE APPROXIMATELY IN THE MIDDLE. THE SUTURE WAS EXCHANGED AGAINST SAME LIKE PRODUCT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292975 ↗
• MalfunctionAug 25, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS TORN DURING BYPASS PROCEDURE (VESSEL WALL), AFTER 1ST - 2ND KNOT (1-2 TISSUE PASSAGES). IN RELATION TO THE NEEDLE, THE SUTURE TORE APPROXIMATELY IN THE MIDDLE. THE SUTURE WAS EXCHANGED AGAINST SAME LIKE PRODUCT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292973 ↗
• MalfunctionAug 25, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS TORN DURING BYPASS PROCEDURE (VESSEL WALL), AFTER 1ST - 2ND KNOT (1-2 TISSUE PASSAGES). IN RELATION TO THE NEEDLE, THE SUTURE TORE APPROXIMATELY IN THE MIDDLE. THE SUTURE WAS EXCHANGED AGAINST SAME LIKE PRODUCT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292972 ↗
• MalfunctionAug 25, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS TORN DURING BYPASS PROCEDURE (VESSEL WALL), AFTER 1ST - 2ND KNOT (1-2 TISSUE PASSAGES). IN RELATION TO THE NEEDLE, THE SUTURE TORE APPROXIMATELY IN THE MIDDLE. THE SUTURE WAS EXCHANGED AGAINST SAME LIKE PRODUCT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292970 ↗

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-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• 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

…and 6 more.