PROLENE M8704Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031045798), received between Jun 16, 2021 and Dec 14, 2023 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ARTERY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE INCORRECT SUTURE AND NEEDLE WERE USED TO SUTURE THE CAROTID ARTERY ANASTOMOSIS. PATIENT COUGHED AND THE SUTURE CAME UNDONE CAUSING A BLEED. WHILE TRYING TO REPAIR THE BLEED THE PATIENTS HEART STOPPED FOR FIVE MINUTES, THEN HER PULSE RETURNED AND PATIENT IS DOING FINE NOW AND WAS RELEASED FROM THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18326599 ↗
• MalfunctionApr 27, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE SUTURES HAD THE NEEDLE BREAKING OFF OF THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14224290 ↗
• MalfunctionApr 27, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE SUTURES HAD THE NEEDLE BREAKING OFF OF THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14224213 ↗
• MalfunctionOct 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE NEEDLE. 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 12650713 ↗
• MalfunctionOct 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE NEEDLE. 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 12650695 ↗
• MalfunctionOct 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE NEEDLE. 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 12650605 ↗
• MalfunctionOct 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE NEEDLE. 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 12650548 ↗
• MalfunctionJun 24, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE NEEDLE POPPED OFF EXTREMELY EASY WHEN TRYING TO USE. THIS SUTURE IS USED FOR ANASTOMOSIS OF SAPHENOUS VEIN TO CORONARY ARTERY - MANY PASSES THROUGH TISSUES ARE REQUIRED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12055714 ↗
• MalfunctionJun 24, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE NEEDLE POPPED OFF EXTREMELY EASY WHEN TRYING TO USE. THIS SUTURE IS USED FOR ANASTOMOSIS OF SAPHENOUS VEIN TO CORONARY ARTERY - MANY PASSES THROUGH TISSUES ARE REQUIRED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12055713 ↗
• MalfunctionJun 16, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED FOR ANASTOMOSIS OF SAPHENOUS VEIN TO THE CORONARY ARTERY. DURING THE PROCEDURE, THE NEEDLE POPPED OFF EXTREMELY EASY WHEN TRYING TO USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12007841 ↗
• MalfunctionJun 16, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED FOR ANASTOMOSIS OF SAPHENOUS VEIN TO THE CORONARY ARTERY. DURING THE PROCEDURE, THE NEEDLE POPPED OFF EXTREMELY EASY WHEN TRYING TO USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12007840 ↗
• MalfunctionJun 16, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED FOR ANASTOMOSIS OF SAPHENOUS VEIN TO THE CORONARY ARTERY. DURING THE PROCEDURE, THE NEEDLE POPPED OFF EXTREMELY EASY WHEN TRYING TO USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12007837 ↗

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-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067

…and 6 more.