PROLENE M8733Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031045972), received between Feb 23, 2021 and Apr 23, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP THEY RECEIVED CALL FROM CVOR COORDINATOR THAT ON 3 CONSECUTIVE STRANDS OF SUTURE, THE SUTURE BROKE ON THE SECOND PASS. THE COORDINATOR STATES THAT THEY SAVED THE AFFECTED SUTURE FOR RETURN AND ANALYSIS. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICES WERE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965897 ↗
• MalfunctionApr 23, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP THEY RECEIVED CALL FROM CVOR COORDINATOR THAT ON 3 CONSECUTIVE STRANDS OF SUTURE, THE SUTURE BROKE ON THE SECOND PASS. THE COORDINATOR STATES THAT THEY SAVED THE AFFECTED SUTURE FOR RETURN AND ANALYSIS. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICES WERE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965894 ↗
• MalfunctionJan 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT BREAKING WHILE ATTEMPTING THE ANASTOMOSIS. THE CASE WAS COMPLETED WITH LIKE DEVICE WITH A DIFFERENT LOT NUMBER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21257553 ↗
• MalfunctionJan 11, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND A SUTURE WAS USED. PRE-OPERATIVELY A HAIR INSIDE THE PACKAGE WAS FOUND. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18494550 ↗
• MalfunctionAug 24, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AV FISTULA PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SEEMED TO COME APART AND THE ANASTOMOSIS HAD TO BE REVISED. THE PATIENT WAS STILL IN THE OPERATING ROOM AND THE REPAIR COULD BE MADE QUICKLY. ONE DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12363445 ↗
• MalfunctionAug 24, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AV FISTULA PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SEEMED TO COME APART AND THE ANASTOMOSIS HAD TO BE REVISED. THE PATIENT WAS STILL IN THE OR AND THE REPAIR COULD BE MADE QUICKLY. ONE DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12363436 ↗
• InjuryAug 3, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN AV FISTULA SURGERY ON (B)(6) 2021 AND THE SUTURE WAS USED FOR ANASTOMOSIS. WHEN THE PATIENT WAS ALREADY IN THE POST-OP UNIT AND PATIENT¿S BLOOD PRESSURE WAS RAISED BACK TO NORMAL LEVEL THE SUTURE SEEMED TO COME APART AND THE ANASTOMOSIS HAD TO BE REVISED. THE PATIENT HAD TO BE RUSHED BACK TO THE OR TO CORRECT THE PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Failure to Anastomose; Hematoma

  MAUDE report 12269639 ↗
• MalfunctionFeb 23, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CABG SURGERY IN 2021 AND THE SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE WAS COMING OFF THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369495 ↗
• MalfunctionFeb 23, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CABG SURGERY IN 2021 AND THE SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE WAS COMING OFF THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369483 ↗

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-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• 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-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881

…and 6 more.