PROLENE EP8706HRecalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10705031218949), received between Jun 3, 2019 and May 18, 2026 — classified as 2 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Break” (49 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 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT THE SURGEON REPORTED THAT DURING SUTURING, THE NEEDLE REPEATEDLY DETACHED FROM THE SUTURE MATERIAL. THE NEEDLE WAS OBSERVED TO SEPARATE FROM THE SUTURE DURING USE, WHICH SHOULD NOT OCCUR. THIS ISSUE HAS BEEN EXPERIENCED MULTIPLE TIMES ACROSS DIFFERENT PROCEDURES. NO PATIENT CONSEQUENCES. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203922 ↗
• MalfunctionMay 18, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT THE SURGEON REPORTED THAT DURING SUTURING, THE NEEDLE REPEATEDLY DETACHED FROM THE SUTURE MATERIAL. THE NEEDLE WAS OBSERVED TO SEPARATE FROM THE SUTURE DURING USE, WHICH SHOULD NOT OCCUR. THIS ISSUE HAS BEEN EXPERIENCED MULTIPLE TIMES ACROSS DIFFERENT PROCEDURES. NO PATIENT CONSEQUENCES. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203920 ↗
• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. AT AROUND 13:10, DURING THE OPERATION, IT WAS FOUND THAT THE SUTURE BROKEN WHEN SUTURING THE BLOOD VESSEL. A NEW SUTURE WAS IMMEDIATELY REPLACED, BUT THE PROBLEM OF EASY BREAKAGE STILL OCCURRED. THE USE OF THE SUTURE WAS IMMEDIATELY STOPPED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662526 ↗
• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. AT AROUND 13:10, DURING THE OPERATION, IT WAS FOUND THAT THE SUTURE BROKEN WHEN SUTURING THE BLOOD VESSEL. A NEW SUTURE WAS IMMEDIATELY REPLACED, BUT THE PROBLEM OF EASY BREAKAGE STILL OCCURRED. THE USE OF THE SUTURE WAS IMMEDIATELY STOPPED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662519 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WIRES BREAK EXTREMELY EASILY. DELAY IN CARE. EQUIPMENT CHANGED REPEATEDLY. THE CUSTOMER DOES NOT KNOW HOW MANY TIMES THE ISSUE OCCURRED, BUT IT OCCURRED FREQUENTLY: BEFORE AND DURING THE USE ON THE PATIENT. IT WAS REQUIRED TO CHANGE THE DEVICE. THE DURATION OF THE DELAY WAS NOT MEASURED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED (ONLY A LOSS OF TIME FOR CHANGING THE DEVICE'S BOX). ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222467 ↗
• MalfunctionJan 23, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. WIRES THAT BREAK EXTREMELY EASILY. DELAY IN CARE. EQUIPMENT CHANGED REPEATEDLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161106 ↗
• MalfunctionJan 12, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT THE SUTURE WAS DISLODGING FROM THE NEEDLE. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24045900 ↗
• MalfunctionMay 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, 3 NEEDLE AND SUTURE BREAK FROM SWAGE END AND NEEDLE DISAPPEARED AND LOST DURING PROXIMAL ANASTOMOSES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 21987601 ↗
• MalfunctionMay 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, 3 NEEDLE AND SUTURE BREAK FROM SWAGE END AND NEEDLE DISAPPEARED AND LOST DURING PROXIMAL ANASTOMOSES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 21987599 ↗
• MalfunctionMay 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, 3 NEEDLE AND SUTURE BREAK FROM SWAGE END AND NEEDLE DISAPPEARED AND LOST DURING PROXIMAL ANASTOMOSES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 21987598 ↗
• MalfunctionNov 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, CV SURGEON FROM HOSPITAL HAD EXPERIENCED SUTURE DETACHED FROM SWAGE FOR PROLENE 6-0 EP8706H WHILE PERFORMING CABG PROCEDURES DURING PROXIMAL ANASTOMOSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674097 ↗
• MalfunctionOct 16, 2024Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON REPORTS THAT HE HAS USED TWO SUTURE THREADS WITH THIS BATCH, THAT THE THREAD HAS BEEN FRAYED AND THAT THE NEEDLE HAS BEEN DETACHED. REPLACED WITH A DIFFERENT LOT OF SUTURE THREAD THE PROBLEM IS SOLVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20462444 ↗
• MalfunctionOct 16, 2024Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON REPORTS THAT HE HAS USED TWO SUTURE THREADS WITH THIS BATCH, THAT THE THREAD HAS BEEN FRAYED AND THAT THE NEEDLE HAS BEEN DETACHED. REPLACED WITH A DIFFERENT LOT OF SUTURE THREAD THE PROBLEM IS SOLVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20462369 ↗
• MalfunctionJun 11, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURE BROKE OFF FROM THE SWAGE AFTER FIRST BITE OF CARDIAC TISSUE DURING CABG PROXIMAL ANASTOMOSES. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19512845 ↗
• MalfunctionApr 19, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142550 ↗
• MalfunctionApr 19, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142549 ↗
• MalfunctionApr 19, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142547 ↗
• MalfunctionApr 19, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142545 ↗
• MalfunctionApr 19, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142540 ↗
• InjuryFeb 29, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ANEURYSM REPAIR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE RENAL VEIN SUTURE, THE SUTURE BROKE LEAVING THE VESSEL OPEN. THE SURGEON HAD TO REMOVE THE SUTURE TWO STEPS IN ORDER TO BE ABLE TO TIE THE KNOT ON THE SUTURE THREAD. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. THE PATIENT DIED INTRA-OP. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; Perforation of Vessels

  MAUDE report 18810723 ↗
• MalfunctionOct 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN KNOTTING DURING SURGERY. CHANGED ANOTHER FIVE SUTURES TO CONTINUE THE SURGERY, BUT THE SAME PROBLEM HAPPENED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17939888 ↗
• MalfunctionOct 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN KNOTTING DURING SURGERY. CHANGED ANOTHER FIVE SUTURES TO CONTINUE THE SURGERY, BUT THE SAME PROBLEM HAPPENED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17939876 ↗
• MalfunctionOct 10, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IMPELLA INSERTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING UNKNOWN TISSUE THE NEEDLE OF TWO SUTURES CODES POPPED OFF. THIS HAPPENED MULTIPLE TIMES THROUGHOUT THE PROCEDURE. NEEDLE WAS NEVER UNACCOUNTED FOR. ADDITIONAL SUTURES WERE USED TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ALL SUTURE USED IN THE CASE IS BEING RETURNED INCLUDING THE AFFECTED SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17909537 ↗
• MalfunctionOct 10, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IMPELLA INSERTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING UNKNOWN TISSUE THE NEEDLE OF TWO SUTURES CODES POPPED OFF. THIS HAPPENED MULTIPLE TIMES THROUGHOUT THE PROCEDURE. NEEDLE WAS NEVER UNACCOUNTED FOR. ADDITIONAL SUTURES WERE USED TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ALL SUTURE USED IN THE CASE IS BEING RETURNED INCLUDING THE AFFECTED SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17909535 ↗
• MalfunctionOct 2, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN LEISTEN TEA SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES DISSOLVED FROM THE SUTURE DURING SEWING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17852865 ↗

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-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• 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-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• 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-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067

…and 6 more.