PROLENE EPM8739Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10705031218932), received between Jan 30, 2019 and Sep 30, 2026 — classified as 1 injury, 40 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Delivered as Unsterile Product

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949209 ↗
• MalfunctionAug 6, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50157211 ↗
• MalfunctionJan 22, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN CORONARY ARTERY BYPASS GRAFTING PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS EASIER TO BREAK THAN USUAL DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24149626 ↗
• MalfunctionJan 22, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFTING PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS EASIER TO BREAK THAN USUAL DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147178 ↗
• MalfunctionNov 13, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, IT WAS FOUND THAT THERE WAS A FOREIGN MATTER IN THE STERILIZATION PACKAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541953 ↗
• MalfunctionNov 13, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, IT WAS FOUND THAT THERE WAS A FOREIGN MATTER IN THE STERILIZATION PACKAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541952 ↗
• MalfunctionOct 22, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN OPEN CARDIOVASCULAR SURGERY, THE SALES REP HEARD THAT THE SUTURE WAS BROKEN DURING USE AS A STORY IN THE PAST. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360760 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN OPEN ABDOMEN/CHEST SURGERY, THE SUTURE WAS BROKEN WHEN THE PRODUCT WAS USED AND LIGATED. ANOTHER PRODUCT WAS USED, BUT THE SUTURE WAS BROKEN AS WELL. AFTER THAT SOME PRODUCTS COULD BE USED NORMALLY BUT THE SAME EVENT OCCURRED THREE TIMES WITH THE SAME BOX. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22713459 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN OPEN ABDOMEN/CHEST SURGERY, THE SUTURE WAS BROKEN WHEN THE PRODUCT WAS USED AND LIGATED. ANOTHER PRODUCT WAS USED, BUT THE SUTURE WAS BROKEN AS WELL. AFTER THAT SOME PRODUCTS COULD BE USED NORMALLY BUT THE SAME EVENT OCCURRED THREE TIMES WITH THE SAME BOX. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22713447 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN OPEN ABDOMEN/CHEST SURGERY, THE SUTURE WAS BROKEN WHEN THE PRODUCT WAS USED AND LIGATED. ANOTHER PRODUCT WAS USED, BUT THE SUTURE WAS BROKEN AS WELL. AFTER THAT SOME PRODUCTS COULD BE USED NORMALLY BUT THE SAME EVENT OCCURRED THREE TIMES WITH THE SAME BOX. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22713439 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN OPEN ABDOMEN/CHEST SURGERY, THE SUTURE WAS BROKEN WHEN THE PRODUCT WAS USED AND LIGATED. ANOTHER PRODUCT WAS USED, BUT THE SUTURE WAS BROKEN AS WELL. AFTER THAT SOME PRODUCTS COULD BE USED NORMALLY BUT THE SAME EVENT OCCURRED THREE TIMES WITH THE SAME BOX. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22713438 ↗
• MalfunctionFeb 21, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE GOT SPLIT BEFORE THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431819 ↗
• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN CARDIO VASCULAR CASE, THEY WERE TWO EVERPOINT CODES THAT THE SUTURE BROKE. CASE WAS COMPLETED WITH A LIKE DEVICE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403711 ↗
• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN CARDIOVASCULAR CASE, THEY WERE TWO EVERPOINT CODES THAT THE SUTURE BROKE. CASE WAS COMPLETED WITH A LIKE DEVICE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401979 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED, THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE. AND SUTURE WAS USED. DURING A CABG PROCEDURE, THAT THE SUTURE BROKE, WHILE TYING AFTER FINISHING THE ANASTOMOSIS. SURGEON PULLED ANOTHER SUTURE AND IT AGAIN BROKE, WHILE TYING. NEITHER BROKE AT THE NEEDLE WEDGE. A THIRD SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20820676 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A CABG PROCEDURE THAT THE SUTURE BROKE WHILE TYING AFTER FINISHING THE ANASTOMOSIS. SURGEON PULLED ANOTHER SUTURE AND IT AGAIN BROKE WHILE TYING. NEITHER BROKE AT THE NEEDLE SWEDGE. A THIRD SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20820660 ↗
• MalfunctionNov 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PROBLEM THE SUTURE PULLING OFF THE NEEDLE HAPPENED DURING USE, AFFECTING SUTURING AND DELAYING SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761711 ↗
• MalfunctionMay 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. ON MULTIPLE OCCASIONS, THE NEEDLE "POPPED OFF" FROM THE SUTURE, REQUIRING ANOTHER TO BE OPENED. WHEN ASKED HOW MANY TIMES, THE NURSE BELIEVED THERE WERE LESS THAN 12, BUT COULD NOT BE MORE SPECIFIC. TWO BOXES OF THE SAME LOT NUMBER WERE INVOLVED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19341660 ↗
• MalfunctionMay 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. ON MULTIPLE OCCASIONS, THE NEEDLE "POPPED OFF" FROM THE SUTURE, REQUIRING ANOTHER TO BE OPENED. WHEN ASKED HOW MANY TIMES, THE NURSE BELIEVED THERE WERE LESS THAN 12, BUT COULD NOT BE MORE SPECIFIC. TWO BOXES OF THE SAME LOT NUMBER WERE INVOLVED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19341659 ↗
• MalfunctionMay 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. ON MULTIPLE OCCASIONS, THE NEEDLE "POPPED OFF" FROM THE SUTURE, REQUIRING ANOTHER TO BE OPENED. WHEN ASKED HOW MANY TIMES, THE NURSE BELIEVED THERE WERE LESS THAN 12, BUT COULD NOT BE MORE SPECIFIC. TWO BOXES OF THE SAME LOT NUMBER WERE INVOLVED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19341650 ↗
• MalfunctionMay 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. ON MULTIPLE OCCASIONS, THE NEEDLE "POPPED OFF" FROM THE SUTURE, REQUIRING ANOTHER TO BE OPENED. WHEN ASKED HOW MANY TIMES, THE NURSE BELIEVED THERE WERE LESS THAN 12, BUT COULD NOT BE MORE SPECIFIC. TWO BOXES OF THE SAME LOT NUMBER WERE INVOLVED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19341649 ↗
• MalfunctionApr 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE DOCTOR REMOVED THE SUTURE DURING THE SURGERY AND FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164437 ↗
• MalfunctionApr 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153609 ↗
• MalfunctionApr 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153602 ↗
• MalfunctionApr 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE WAS DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014504 ↗

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-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• 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-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031

…and 6 more.