PROLENE M8737Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705031046016), received between May 10, 2021 and Aug 5, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Material Separation” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50146869 ↗
• MalfunctionNov 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON THAT A 7/0 PROLENE BROKE DURING A CABG CASE THERE WAS A SLIGHT DELAY IN CASE WAITING TO GRAB ANOTHER STITCH. NO PATIENT CONSEQUENCES. THERE WAS ALSO SLIGHT ADDED TIME TO THE HEART HAVING TO BE MANIPULATED. AFTER SOME DIGGING THE SUTURE CAME IN A MEDLINE PREPACK FOR THE SPECIFIC DOCTOR AND CASE. THIS HAS HAPPENED SEVERAL TIMES WITH 7/0 PROLENE THAT COME IN THE MEDLINE PACKS. THEY GRAB THE SUTURE OFF THE SUTURE CART AND HAVE NO ISSUES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23586188 ↗
• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEON SUTURE BROKE DURING A CABG CASE THERE WAS A SLIGHT DELAY IN CASE WAITING TO GRAB ANOTHER STITCH. NO PATIENT CONSEQUENCES. THERE WAS ALSO SLIGHT ADDED TIME TO THE HEART HAVING TO BE MANIPULATED. AFTER SOME DIGGING THE SUTURE CAME IN A MEDLINE PREPACK FOR THE SPECIFIC DOCTOR AND CASE. THIS HAS HAPPENED SEVERAL TIMES WITH SUTURE THAT COME IN THE MEDLINE PACKS. THEY GRAB THE SUTURE OFF THE SUTURE CART AND HAVE NO ISSUES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569136 ↗
• MalfunctionOct 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT NEEDLES AE COMING UNWEDGED WITH LITTLE TO NO EFFORT. REMOVING ALL LOT 106BC1. TRIED GETTING RID OF THE PACK AND OPEN NEW ONE AND THE SAME THING OCCURRED ALL SAME LOT. NO SURGICAL DELAY WAS THERE. NO PATIENT HARM WAS REPORTED. DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324430 ↗
• MalfunctionOct 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT NEEDLES AE COMING UNWEDGED WITH LITTLE TO NO EFFORT. REMOVING ALL LOT 106BC1. TRIED GETTING RID OF THE PACK AND OPEN NEW ONE AND THE SAME THING OCCURRED ALL SAME LOT. NO SURGICAL DELAY WAS THERE. NO PATIENT HARM WAS REPORTED. DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324416 ↗
• MalfunctionOct 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT NEEDLES AE COMING UNWEDGED WITH LITTLE TO NO EFFORT. REMOVING ALL LOT 106BC1. TRIED GETTING RID OF THE PACK AND OPEN NEW ONE AND THE SAME THING OCCURRED ALL SAME LOT. NO SURGICAL DELAY WAS THERE. NO PATIENT HARM WAS REPORTED. DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324369 ↗
• MalfunctionSep 19, 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, IT WAS REPORTED THAT CVOR DIRECTOR REACHED OUT TO SALES REP SAYING A NEEDLE DETACHED FROM THE 8-0 SUTURE WHILE THE SURGEON WAS USING IT. THE SURGEON STATED THERE WAS NO ADDITIONAL FORCE WHEN IT DETACHED. SURGICAL DELAY WAS UNKNOWN. PATIENT CONSEQUENCES WAS UNKNOWN. DEVICE WAS NOT RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100407 ↗
• MalfunctionSep 9, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE IN 2025 AND SUTURE WAS USED. THE SUTURES ARE BREAKING MID STRAND AND NEEDLE HAS POPPED OFF THE SUTURES DURING USE. THEY HAD TO RESTART THE ANASTOMOSIS WITH A FRESH SUTURE FROM OFF THE SHELF. LONGER PROCEDURE TIME. NO ISSUES AFTER RETRIEVING A NEW STITCH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23010528 ↗
• MalfunctionSep 9, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE IN 2025 AND SUTURE WAS USED. THE SUTURES ARE BREAKING MID STRAND AND NEEDLE HAS POPPED OFF THE SUTURES DURING USE. THEY HAD TO RESTART THE ANASTOMOSIS WITH A FRESH SUTURE FROM OFF THE SHELF. LONGER PROCEDURE TIME. NO ISSUES AFTER RETRIEVING A NEW STITCH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23010228 ↗
• MalfunctionMar 30, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NORWOOD PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLES WERE BREAKING OFF. THEY WERE RETRIEVED AND THE CASE COMPLETED WITH NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16642750 ↗
• MalfunctionAug 1, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A CABG PROCEDURE THAT THE SUTURE IS BREAKING WHILE SUTURING THE GRAPH. ANOTHER LIKE DEVICE OF THE SAME LOT 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 15142553 ↗
• MalfunctionMay 11, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC CARDIAC SURGERY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE DURING SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14361691 ↗
• MalfunctionJun 16, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE NEEDLE POPPED OFF THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12012842 ↗
• MalfunctionJun 14, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT CABG PROCEDURE ON (B)(6) 2021 AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995918 ↗
• MalfunctionJun 14, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT CABG PROCEDURE ON (B)(6) 2021 AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995913 ↗
• MalfunctionMay 10, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A CORONARY BYPASS GRAFTS SEVERAL SUTURES BROKE IN THE MIDDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11798839 ↗

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-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• 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-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748

…and 6 more.