PROLENE EPM8742Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031206717), received between Jun 29, 2021 and May 22, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ANASTOMOSIS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING VASCULAR ANASTOMOSIS, THE SUTURE BROKE DURIG USE ON THE PATIENT. ANOTHER LOT OF PRODUCTS WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075590 ↗
• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ANASTOMOSIS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING VASCULAR ANASTOMOSIS, THE SUTURE BROKE DURIG USE ON THE PATIENT. ANOTHER LOT OF PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075588 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANASTOMOSIS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING VASCULAR ANASTOMOSIS, THE SUTURE WAS BROKEN AFTER THREE STITCHES. THIS OCCURRED AT LEAST THREE TIMES EVEN AFTER THE NEEDLE WAS CHANGED. (IT HAPPENED EVEN AFTER 2 PACKAGES WERE OPENED.) THIS EVENT WAS FOUND BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER LOT OF PRODUCTS WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884694 ↗
• MalfunctionJun 20, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE THE DEVICE BROKE DURING ANASTOMOSIS. THEY GOT ANOTHER DEVICE TO FINISH THE REST OF THE CABG/HEART VALVE PROCEDURE WITHIN PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19576498 ↗
• MalfunctionDec 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL AORTIC ANEURYSM PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BETWEEN 3-4 THROW'S GRIPPING THE NEEDLE IT ROLLED ON HIM. THE SURGEON RE-GRIPED TO FINISH THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18408799 ↗
• MalfunctionJun 29, 2021Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING THE SURGERY, ALTHOUGH NO EXTRA FORCE WAS APPLIED, THE NEEDLE WAS DETACHED FROM THE SUTURE. IN ADDITION, THE SUTURE WAS BROKEN WHEN TYING. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12083862 ↗

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-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• 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
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879

…and 6 more.