PROLENE M8701Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031045767), received between Dec 26, 2018 and Apr 14, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT DURING CARDIOVASCULAR PROCEDURE THE SUTURE WAS BREAKING, AND THE NEEDLE WAS PULLING THE SUTURE THREAD OFF. IT HAPPENED MULTIPLE TIMES ACROSS MULTIPLE SURGERY. 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 24872712 ↗
• MalfunctionApr 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT DURING CARDIOVASCULAR PROCEDURE THE SUTURE WAS BREAKING, AND THE NEEDLE WAS PULLING THE SUTURE THREAD OFF. IT HAPPENED MULTIPLE TIMES ACROSS MULTIPLE SURGERY. 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 24872677 ↗
• MalfunctionMar 12, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WERE USED. DURING THE PROCEDURE THE SUTURE WAS BREAKING, AND THE NEEDLE WAS PULLING THE SUTURE THREAD OFF. IT HAPPENED MULTIPLE TIMES ACROSS MULTIPLE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579546 ↗
• MalfunctionMar 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WERE USED. DURING THE PROCEDURE THE SUTURE WAS BREAKING, AND THE NEEDLE WAS PULLING THE SUTURE THREAD OFF. IT HAPPENED MULTIPLE TIMES ACROSS MULTIPLE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579465 ↗
• MalfunctionNov 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT DURING A CABG THE NEEDLE BROKE. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496691 ↗
• MalfunctionNov 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT DURING A CABG THE NEEDLE BROKE. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496655 ↗
• MalfunctionJun 21, 2022Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND A SUTURE WAS USED. DURING USE, SUTURE BREAKING. A NEW SUTURE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14760019 ↗
• MalfunctionJun 21, 2022Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND A SUTURE WAS USED. DURING USE, SUTURE BREAKING. A NEW SUTURE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14759992 ↗
• MalfunctionJun 21, 2022Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND A SUTURE WAS USED. DURING USE, SUTURE BREAKING. A NEW SUTURE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14759986 ↗
• MalfunctionApr 15, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE EASIER THAN NORMAL WHEN TYING. ANOTHER LIKE DEVICE 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 11675745 ↗
• MalfunctionDec 10, 2020Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THE CUSTOMER OPENED THE BOX, THE SUTURES HAD A DIFFERENT SIZE NEEDLE INSIDE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10987949 ↗
• MalfunctionDec 10, 2020Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THE CUSTOMER OPENED THE BOX, THE SUTURES HAD A DIFFERENT SIZE NEEDLE INSIDE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10987940 ↗
• MalfunctionNov 6, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE AFTER COMPLETION OF THE ANASTOMOSES BUT WAS REDONE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10802977 ↗
• MalfunctionDec 26, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED A PATIENT UNDERWENT A HEART BYPASS SURGERY ON (B)(6) 2018, AND SUTURE WAS USED. IT WAS FOUND THAT TWO PRODUCT NUMBERS OF M8701 AND M8710 WERE PRINTED ON THE BOX BEFORE OPENING THE BOX. THE BOX WAS NOT USED FOR THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED . THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8195617 ↗

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-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• 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-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• 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-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• 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-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844

…and 6 more.