PROLENE W8667Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031201897), received between Dec 4, 2024 and Mar 4, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE MECHANICAL VALVE REPLACEMENT SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SURGICAL PROCEDURE FOR THE PATIENT, SUTURE WAS USED TO SUTURE THE INTERIOR OF THE HEART. HOWEVER, DURING USE, THE SUTURE WAS PRONE TO BREAKAGE WHEN KNOTTED, AND THE SAME SITUATION PERSISTED FOR SEVERAL CONSECUTIVE SUTURES. THE DOCTOR USED ALTERNATIVE SUTURE INSTEAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24511895 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE MECHANICAL VALVE REPLACEMENT SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SURGICAL PROCEDURE FOR THE PATIENT, SUTURE WAS USED TO SUTURE THE INTERIOR OF THE HEART. HOWEVER, DURING USE, THE SUTURE WAS PRONE TO BREAKAGE WHEN KNOTTED, AND THE SAME SITUATION PERSISTED FOR SEVERAL CONSECUTIVE SUTURES. THE DOCTOR USED ALTERNATIVE SUTURE INSTEAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505748 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE MECHANICAL VALVE REPLACEMENT SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, DURING THE SURGICAL PROCEDURE FOR THE PATIENT, SUTURE WAS USED TO SUTURE THE INTERIOR OF THE HEART. HOWEVER, DURING USE, THE SUTURE WAS PRONE TO BREAKAGE WHEN KNOTTED, AND THE SAME SITUATION PERSISTED FOR SEVERAL CONSECUTIVE SUTURES. THE DOCTOR USED ALTERNATIVE SUTURE INSTEAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388030 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE MECHANICAL VALVE REPLACEMENT SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, DURING THE SURGICAL PROCEDURE FOR THE PATIENT, SUTURE WAS USED TO SUTURE THE INTERIOR OF THE HEART. HOWEVER, DURING USE, THE SUTURE WAS PRONE TO BREAKAGE WHEN KNOTTED, AND THE SAME SITUATION PERSISTED FOR SEVERAL CONSECUTIVE SUTURES. THE DOCTOR USED ALTERNATIVE SUTURE INSTEAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388018 ↗
• MalfunctionDec 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LOBECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20843337 ↗

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-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• 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-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662

…and 6 more.