PROLENE M8731Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031045958), received between May 26, 2020 and Apr 2, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE ON AND UNKNOWN DATE IN 2024, AND SUTURE WAS USED ON THE VESSELS. THE NEEDLE ON THE 7-0 PROLENE POPPED OFF DURING VESSEL ANASTOMOSIS. A NEW PACKET OF THE SAME SUTURE FROM THE SAME BOX WAS OPENED AND IT OCCURRED AGAIN DURING THE ANASTOMOSIS. THE HCP OPENED ANOTHER BOX OF THE SAME LOT NUMBER AND EXPERIENCED THE SAME THING OFF OF THE SURGICAL FIELD WHEN TESTED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19019634 ↗
• MalfunctionApr 2, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE ON AND UNKNOWN DATE IN 2024, AND SUTURE WAS USED ON THE VESSELS. THE NEEDLE ON THE 7-0 PROLENE POPPED OFF DURING VESSEL ANASTOMOSIS. A NEW PACKET OF THE SAME SUTURE FROM THE SAME BOX WAS OPENED AND IT OCCURRED AGAIN DURING THE ANASTOMOSIS. THE HCP OPENED ANOTHER BOX OF THE SAME LOT NUMBER AND EXPERIENCED THE SAME THING OFF OF THE SURGICAL FIELD WHEN TESTED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19019631 ↗
• MalfunctionNov 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2020; AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10773805 ↗
• MalfunctionMay 26, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACOTOMY ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DEVICE KEPT BREAKING. SWITCHED TO ANOTHER LOT TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10086570 ↗
• MalfunctionMay 26, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACOTOMY ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DEVICE KEPT BREAKING. SWITCHED TO ANOTHER LOT TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10086569 ↗
• MalfunctionMay 26, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACOTOMY ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DEVICE KEPT BREAKING. SWITCHED TO ANOTHER LOT TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10086568 ↗

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-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• 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-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• 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.