PROLENE W8712Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031128286), received between Nov 8, 2024 and Nov 14, 2024 — classified as 2 deaths.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathNov 14, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT WITH A VENTRICULAR SEPTAL DEFECT UNDERWENT SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. ON (B)(6) 2024, AN ULTRASOUND/ ECHOCARDIOGRAPHY WAS PERFORMED. ON (B)(6) 2024, A REPEAT SURGERY WAS PERFORMED BECAUSE THE THREADS HAD BROKEN. ONE SUTURE ON THE TRICUSPID VALVE IN THE AREA OF THE ANTERIOR VALVE WAS UNRAVELED. THE PATIENT'S CONDITION IS SERIOUS. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT OF THE CHILDREN'S HOSPITAL FOR APPROPRIATE INTENSIVE CARE IN THE POSTOPERATIVE PERIOD. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; Intraoperative Cardiac Injury

  MAUDE report 20688972 ↗
• DeathNov 8, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT WITH A VENTRICULAR SEPTAL DEFECT UNDERWENT SURGERY ON (B)(6)2024 AND SUTURE WAS USED. ON (B)(6)2024, AN ULTRASOUND /ECHOCARDIOGRAPHY WAS PERFORMED. ON (B)(6)2024, A REPEAT SURGERY WAS PERFORMED BECAUSE THE THREADS HAD BROKEN. THE PATIENT'S CONDITION IS SERIOUS. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT OF THE (B)(6) HOSPITAL FOR APPROPRIATE INTENSIVE CARE IN THE POSTOPERATIVE PERIOD. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; Intraoperative Cardiac Injury

  MAUDE report 20643936 ↗

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-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• 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-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• 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-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• 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-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631

…and 6 more.