PROLENE EP8729HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031228344), received between Dec 16, 2025 and Dec 16, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANASTOMOSIS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A BYPASS HEART SURGERY, SUTURING THE ANASTOMOSIS. A TOTAL OF SIX SUTURES NEED TO BE OPENED. THE NEEDLE KEEPS DETACHING FROM THE THREAD REPEATEDLY¿EITHER ALREADY WHEN BEING PULLED OUT OF THE PACKAGING BY THE SCRUB NURSE OR EVEN WHILE SUTURING THE ANASTOMOSIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816175 ↗
• MalfunctionDec 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANASTOMOSIS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A BYPASS HEART SURGERY, SUTURING THE ANASTOMOSIS. A TOTAL OF SIX SUTURES NEED TO BE OPENED. THE NEEDLE KEEPS DETACHING FROM THE THREAD REPEATEDLY¿EITHER ALREADY WHEN BEING PULLED OUT OF THE PACKAGING BY THE SCRUB NURSE OR EVEN WHILE SUTURING THE ANASTOMOSIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816174 ↗
• MalfunctionDec 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANASTOMOSIS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A BYPASS HEART SURGERY, SUTURING THE ANASTOMOSIS. A TOTAL OF SIX SUTURES NEED TO BE OPENED. THE NEEDLE KEEPS DETACHING FROM THE THREAD REPEATEDLY¿EITHER ALREADY WHEN BEING PULLED OUT OF THE PACKAGING BY THE SCRUB NURSE OR EVEN WHILE SUTURING THE ANASTOMOSIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816172 ↗
• MalfunctionDec 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANASTOMOSIS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A BYPASS HEART SURGERY, SUTURING THE ANASTOMOSIS. A TOTAL OF SIX SUTURES NEED TO BE OPENED. THE NEEDLE KEEPS DETACHING FROM THE THREAD REPEATEDLY¿EITHER ALREADY WHEN BEING PULLED OUT OF THE PACKAGING BY THE SCRUB NURSE OR EVEN WHILE SUTURING THE ANASTOMOSIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816171 ↗
• MalfunctionDec 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANASTOMOSIS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A BYPASS HEART SURGERY, SUTURING THE ANASTOMOSIS. A TOTAL OF SIX SUTURES NEED TO BE OPENED. THE NEEDLE KEEPS DETACHING FROM THE THREAD REPEATEDLY¿EITHER ALREADY WHEN BEING PULLED OUT OF THE PACKAGING BY THE SCRUB NURSE OR EVEN WHILE SUTURING THE ANASTOMOSIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816170 ↗

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-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• 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-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• 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-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995

…and 6 more.