PROLENE EPM8702Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10705031134805), received between Apr 18, 2019 and Sep 24, 2026 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Material Separation” (25 reports).

29 other recalls cover devices cleared under the same FDA submission (K133356, K946173); 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Material Separation

  It was reported a patient underwent a CABG procedure on an unknown date in 2026 and suture was used. Surgeon had a needle from suture pop off the suture when she was throwing down knots. The needle was found, the case was completed as normal and there was no patient consequence. There was no patient consequence reported. An additional 20 minutes was added to the case. The device was not returning. Additional information has been requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886682 ↗
• MalfunctionSep 24, 2026Material Separation

  It was reported a patient underwent a CABG procedure on (b)(6) 2026 and suture was used. Surgeon had a needle from suture pop off the suture when she was throwing down knots. The needle was found, the case was completed as normal and there was no patient consequence. There was no patient consequence reported. An additional 20 minutes was added to the case. The device was not returning. Additional information has been requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886681 ↗
• MalfunctionMay 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE NEEDLES CONSISTENTLY POPPING OFF OF 6-0 AND 7-0 SUTURES DURING A CABG CASE. OPENED NEW ONE TO COMPLETED THE PROCEDURE. PROCEDURE DELAY WAS DUE TO THE REPORTED EVENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25165091 ↗
• MalfunctionMay 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE NEEDLES CONSISTENTLY POPPING OFF OF 6-0 AND 7-0 SUTURES DURING A CABG CASE. OPENED NEW ONE TO COMPLETED THE PROCEDURE. PROCEDURE DELAY WAS DUE TO THE REPORTED EVENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164916 ↗
• MalfunctionMay 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE NEEDLES CONSISTENTLY POPPING OFF OF 6-0 AND 7-0 SUTURES DURING A CABG CASE. OPENED NEW ONE TO COMPLETED THE PROCEDURE. PROCEDURE DELAY WAS DUE TO THE REPORTED EVENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164911 ↗
• MalfunctionMay 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE NEEDLES CONSISTENTLY POPPING OFF OF 6-0 AND 7-0 SUTURES DURING A CABG CASE. OPENED NEW ONE TO COMPLETED THE PROCEDURE. PROCEDURE DELAY WAS DUE TO THE REPORTED EVENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164901 ↗
• MalfunctionJul 23, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY SALES REP PER ACCOUNT THAT BOTH LOTS HAVING THE SAME ISSUE. BREAKING WHEN TYING KNOTS AND DETACHING FROM THE NEEDLE. NO ADVERSE IMPACT PATIENT/USER WAS REPORTED. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576871 ↗
• MalfunctionJul 23, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY SALES REP PER ACCOUNT THAT BOTH LOTS HAVING THE SAME ISSUE. BREAKING WHEN TYING KNOTS AND DETACHING FROM THE NEEDLE. NO ADVERSE IMPACT PATIENT/USER WAS REPORTED. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576839 ↗
• MalfunctionJul 23, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY SALES REP PER ACCOUNT THAT BOTH LOTS HAVING THE SAME ISSUE. BREAKING WHEN TYING KNOTS AND DETACHING FROM THE NEEDLE. NO ADVERSE IMPACT PATIENT/USER WAS REPORTED. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576827 ↗
• MalfunctionOct 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED FROM THE SURGEON THAT THE SUTURE HAD MORE MEMORY THAN WHAT HE WAS USED TO, AND THE NEEDLES APPEARED TO POP OFF MUCH EASIER THAN THE NORM. NEEDLES WERE RETRIEVED AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515290 ↗
• MalfunctionAug 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2023, AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17514637 ↗
• MalfunctionAug 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OF THE SWAGE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17512105 ↗
• MalfunctionJul 25, 2023Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE BROKE AT MIDPOINT WITH NO TENSION. THE SURGEON STATED THAT THE NEEDLE WAS TOO SHARP AND THERE IS DRAG AS YOU PULL THE NEEDLE THROUGH AND ON THE FRIABLE CORONARY ARTERY, IT TORE THE TISSUE. A NEW SUTURE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 17390635 ↗
• MalfunctionJul 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRANSPLANT PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE 7-0 EVERPOINT NEEDLES WERE POPPING OFF THE SUTURE. PROCEDURE WAS DELAYED BY TEN MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302539 ↗
• MalfunctionJul 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRANSPLANT PROCEDURE IN (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE 7-0 EVERPOINT NEEDLES WERE POPPING OFF THE SUTURE. PROCEDURE WAS DELAYED BY TEN MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302538 ↗
• MalfunctionJul 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRANSPLANT PROCEDURE IN (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE 7-0 EVERPOINT NEEDLES WERE POPPING OFF THE SUTURE. PROCEDURE WAS DELAYED BY TEN MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302537 ↗
• MalfunctionJul 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRANSPLANT PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE 7-0 EVERPOINT NEEDLES WERE POPPING OFF THE SUTURE. PROCEDURE WAS DELAYED BY TEN MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302535 ↗
• MalfunctionJul 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRANSPLANT PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE 7-0 EVERPOINT NEEDLES WERE POPPING OFF THE SUTURE. PROCEDURE WAS DELAYED BY TEN MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302530 ↗
• MalfunctionJul 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRANSPLANT PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE 7-0 EVERPOINT NEEDLES WERE POPPING OFF THE SUTURE. PROCEDURE WAS DELAYED BY TEN MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302529 ↗
• MalfunctionJul 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN MAKING THE FIRST PASS THROUGH THE VESSEL, THE SUTURE BROKE BUT DID NOT DETACH FROM THE NEEDLE. ANOTHER LIKE SUTURE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17301672 ↗
• MalfunctionJul 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN MAKING THE FIRST PASS THROUGH THE VESSEL, THE SUTURE BROKE BUT DID NOT DETACH FROM THE NEEDLE. ANOTHER LIKE SUTURE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17301613 ↗
• MalfunctionNov 1, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFTING PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE PRODUCT WAS USED FOR THE BLOOD VESSEL. THE NEEDLE CAME OFF DURING USE AND FELL INTO THE BODY CAVITY. ALTHOUGH IT TOOK TIME, THE NEEDLE WAS RETRIEVED FROM THE BODY. AFTER THE SURGEON LOST SIGHT OF THE NEEDLE, THE INSIDE OF THE BODY CAVITY WAS CHECKED, BUT THE NEEDLE WAS NOT FOUND, BUT THEN IT WAS FOUND OUTSIDE THE PATIENT'S BODY (IT WAS FOUND ON THE BODY). IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADDITIONAL TREATMENT WAS PERFORMED. AFTER THAT, THERE WAS NO PROBLEM WITH THE PATIENT'S CONDITION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15711403 ↗
• MalfunctionNov 2, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12740902 ↗
• MalfunctionNov 2, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12740899 ↗
• MalfunctionAug 10, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THE SURGEON OPINED THAT THE SUTURE LOOKED FRAYED OR ALMOST "CRYSTALLIZED" IN APPEARANCE WHERE IT BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12303388 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133356, K946173. 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-1516-2025 · Mar 7, 2025 · Open, Classified
  ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
• 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-1097-2025 · Dec 20, 2024 · Open, Classified
  PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovas
• Z-2486-2020 · Jun 10, 2020 · Open, Classified
  PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870
• Z-1841-2019 · Apr 19, 2019 · Terminated
  ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue app
• Z-1842-2019 · Apr 19, 2019 · Terminated
  ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue appr
• Z-0747-2019 · Dec 18, 2018 · Terminated
  PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approxima
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748

…and 14 more.