PROLENE M8743Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705031046061), received between Feb 7, 2020 and Sep 15, 2026 — classified as 16 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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 15, 2026Break

  It was reported that a patient underwent a cardiovascular procedure on (b)(6) 2026 and suture was used. It was reported that the suture broke during a CVOR case. The product was discarded. There were no patient consequence reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777950 ↗
• MalfunctionAug 5, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147719 ↗
• MalfunctionMay 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OPEN-HEART PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEON WHO HAD AN 8-0 NEEDLE POP OFF DURING AN OPEN-HEART PROCEDURE. HE SAID THERE WAS NO TENSION ON THE NEEDLE AND IT WAS ARMED PROPERLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280674 ↗
• MalfunctionMay 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN-HEART SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE CVOR CHARGE NURSE THAT A NEEDLE POPPED OFF WHILE SURGEON WAS OPERATING. THIS WAS DURING AN OPEN-HEART PROCEDURE. SURGICAL DELAY UNKNOWN. UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCES DUE TO THE REPORTED EVENT. DEVICE IS NOT RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279624 ↗
• MalfunctionMay 19, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANASTOMOSIS PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE CVOR CLINICAL COORDINATOR THAT A SURGEON EXPERIENCED 4 SEPARATE NEEDLES POPPING OFF DURING AN ANASTOMOSIS. THEY ARE ALL THE SAME LOT NUMBER. UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT CONSEQUENCES WERE UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216970 ↗
• MalfunctionMay 19, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANASTOMOSIS PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE CVOR CLINICAL COORDINATOR THAT A SURGEON EXPERIENCED 4 SEPARATE NEEDLES POPPING OFF DURING AN ANASTOMOSIS. THEY ARE ALL THE SAME LOT NUMBER. UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT CONSEQUENCES WERE UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216968 ↗
• MalfunctionMay 19, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANASTOMOSIS PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE CVOR CLINICAL COORDINATOR THAT A SURGEON EXPERIENCED 4 SEPARATE NEEDLES POPPING OFF DURING AN ANASTOMOSIS. THEY ARE ALL THE SAME LOT NUMBER. UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT CONSEQUENCES WERE UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216966 ↗
• MalfunctionMay 19, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANASTOMOSIS PROCEDURE ON 11-MAY2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE CVOR CLINICAL COORDINATOR THAT A SURGEON EXPERIENCED 4 SEPARATE NEEDLES POPPING OFF DURING AN ANASTOMOSIS. THEY ARE ALL THE SAME LOT NUMBER. UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT CONSEQUENCES WERE UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216964 ↗
• MalfunctionApr 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING A CABG, A NEEDLE POPPED OFF FROM THE END OF SUTURE. THE SURGEON STATED THERE WAS NO EXCESS TENSION ON THE NEEDLE. THIS WAS IN THE MIDDLE OF THE PROCEDURE. THEY OPENED AN ADDITIONAL SUTURE AND PROCEEDED WITH THE CASE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927786 ↗
• MalfunctionNov 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING UNSPECIFIED PROCEDURE, THE SUTURE BROKE CONTINUOUSLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496519 ↗
• MalfunctionNov 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING UNSPECIFIED PROCEDURE, THE SUTURE BROKE CONTINUOUSLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496517 ↗
• MalfunctionAug 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT, THE SUTURE BROKE. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS NOT FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922516 ↗
• MalfunctionJun 29, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, TWO SUTURES BROKE WHILE TYPING THE ANASTOMOSIS. A THIRD SUTURE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17224060 ↗
• MalfunctionJun 29, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, TWO SUTURES BROKE WHILE TYPING THE ANASTOMOSIS. A THIRD SUTURE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17224059 ↗
• MalfunctionMay 10, 2021Break; Dull, Blunt; Break; Dull, Blunt

  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 11798792 ↗
• MalfunctionFeb 7, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CABG PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE STRAND BROKE IN HALF ON SUTURE. THE PROCEDURE WAS COMPLETED WITH SIMILAR DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9681409 ↗

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-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-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• 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-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416

…and 6 more.