PROLENE W8101Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031127845), received between Oct 22, 2025 and Aug 4, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Defective Component” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50131590 ↗
• MalfunctionOct 22, 2025Material Separation; Defective Component; Insufficient Device Problem Information; Material Separation; Defective Component; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. CUSTOMER REPORTS THAT THE SUTURE HAS BEEN BEHAVING DIFFERENTLY SINCE THE BEGINNING OF AUGUST. THE THREAD IS ROUGHER, LESS MALLEABLE, AND EXHIBITS SIGNIFICANT DRAG WHEN PASSING THROUGH THE TISSUES. AND THE CONNECTION BETWEEN THREAD AND NEEDLE IS NOT THE SAME. THIS CUSTOMER USES THE SUTURE FOR A LONG TIME AGO (MANY, MANY YEARS). IT IS A CARDIOTHORACIC DEPARTMENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360978 ↗
• MalfunctionOct 22, 2025Material Separation; Defective Component; Material Integrity Problem; Insufficient Device Problem Information; Material Separation; Defective Component; Material Integrity Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. CUSTOMER REPORTS THAT THE SUTURE HAS BEEN BEHAVING DIFFERENTLY SINCE THE BEGINNING OF AUGUST. THE THREAD IS ROUGHER, LESS MALLEABLE, AND EXHIBITS SIGNIFICANT DRAG WHEN PASSING THROUGH THE TISSUES. AND THE CONNECTION BETWEEN THREAD AND NEEDLE IS NOT THE SAME. THIS CUSTOMER USES THE SUTURE FOR A LONG TIME AGO (MANY, MANY YEARS). IT IS A CARDIOTHORACIC DEPARTMENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360965 ↗
• MalfunctionOct 22, 2025Material Separation; Defective Component; Material Integrity Problem; Insufficient Device Problem Information; Material Separation; Defective Component; Material Integrity Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. CUSTOMER REPORTS THAT THE SUTURE HAS BEEN BEHAVING DIFFERENTLY SINCE THE BEGINNING OF AUGUST. THE THREAD IS ROUGHER, LESS MALLEABLE, AND EXHIBITS SIGNIFICANT DRAG WHEN PASSING THROUGH THE TISSUES. AND THE CONNECTION BETWEEN THREAD AND NEEDLE IS NOT THE SAME. THIS CUSTOMER USES THE SUTURE FOR A LONG TIME AGO (MANY, MANY YEARS). IT IS A CARDIOTHORACIC DEPARTMENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360827 ↗

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-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• 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-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• 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

…and 6 more.