PROLENE 8695GRecalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 10705031019164), received between Sep 18, 2019 and Aug 11, 2026 — classified as 72 malfunctions.

The most frequently reported specific device problem is “Break” (58 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 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211470 ↗
• MalfunctionAug 11, 2026Material Separation

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. It was reported to the sales rep that during use of the product, the user reported that the needle detached from the suture. Initially, it was suspected that excessive force during handling may have contributed to the issue; however, the facility indicated that similar needle-to-suture separations had occurred with multiple surgeons. The issue was reported by both male and female surgeons, leading the facility to believe that the event was related to the product rather than user technique. No patient consequences. Device is not available for return. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211469 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE ACCOUNT HAS AN ISSUE WITH ITEM 8695G. ALL THREE (3) BOXES HAVE THE ISSUE OF SUTURES BREAKING MIDCLOSURE. IN EACH BOX THERE ARE TWELVE (12) SUTURES. NO PATIENT HARM HAS BEEN REPORTED. DEVICE AVAILABILITY IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472144 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE ACCOUNT HAS AN ISSUE WITH ITEM 8695G. ALL THREE (3) BOXES HAVE THE ISSUE OF SUTURES BREAKING MIDCLOSURE. IN EACH BOX THERE ARE TWELVE (12) SUTURES. NO PATIENT HARM HAS BEEN REPORTED. DEVICE AVAILABILITY IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472133 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE ACCOUNT HAS AN ISSUE WITH ITEM 8695G. ALL THREE (3) BOXES HAVE THE ISSUE OF SUTURES BREAKING MIDCLOSURE. IN EACH BOX THERE ARE TWELVE (12) SUTURES. NO PATIENT HARM HAS BEEN REPORTED. DEVICE AVAILABILITY IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471610 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE ACCOUNT HAS AN ISSUE WITH ITEM 8695G. ALL THREE (3) BOXES HAVE THE ISSUE OF SUTURES BREAKING MIDCLOSURE. IN EACH BOX THERE ARE TWELVE (12) SUTURES. NO PATIENT HARM HAS BEEN REPORTED. DEVICE AVAILABILITY IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471608 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE ACCOUNT HAS AN ISSUE WITH ITEM 8695G. ALL THREE (3) BOXES HAVE THE ISSUE OF SUTURES BREAKING MIDCLOSURE. IN EACH BOX THERE ARE TWELVE (12) SUTURES. NO PATIENT HARM HAS BEEN REPORTED. DEVICE AVAILABILITY IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471384 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE ACCOUNT HAS AN ISSUE WITH ITEM 8695G. ALL THREE (3) BOXES HAVE THE ISSUE OF SUTURES BREAKING MIDCLOSURE. IN EACH BOX THERE ARE TWELVE (12) SUTURES. NO PATIENT HARM HAS BEEN REPORTED. DEVICE AVAILABILITY IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471380 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE ACCOUNT HAS AN ISSUE WITH ITEM 8695G. ALL THREE (3) BOXES HAVE THE ISSUE OF SUTURES BREAKING MIDCLOSURE. IN EACH BOX THERE ARE TWELVE (12) SUTURES. NO PATIENT HARM HAS BEEN REPORTED. DEVICE AVAILABILITY IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471370 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE ACCOUNT HAS AN ISSUE WITH ITEM 8695G. ALL THREE (3) BOXES HAVE THE ISSUE OF SUTURES BREAKING MIDCLOSURE. IN EACH BOX THERE ARE TWELVE (12) SUTURES. NO PATIENT HARM HAS BEEN REPORTED. DEVICE AVAILABILITY IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470853 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE ACCOUNT HAS AN ISSUE WITH ITEM 8695G. ALL THREE (3) BOXES HAVE THE ISSUE OF SUTURES BREAKING MIDCLOSURE. IN EACH BOX THERE ARE TWELVE (12) SUTURES. NO PATIENT HARM HAS BEEN REPORTED. DEVICE AVAILABILITY IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470850 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE ACCOUNT HAS AN ISSUE WITH ITEM 8695G. ALL THREE (3) BOXES HAVE THE ISSUE OF SUTURES BREAKING MIDCLOSURE. IN EACH BOX THERE ARE TWELVE (12) SUTURES. NO PATIENT HARM HAS BEEN REPORTED. DEVICE AVAILABILITY IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470400 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE ACCOUNT HAS AN ISSUE WITH ITEM 8695G. ALL THREE (3) BOXES HAVE THE ISSUE OF SUTURES BREAKING MIDCLOSURE. IN EACH BOX THERE ARE TWELVE (12) SUTURES. NO PATIENT HARM HAS BEEN REPORTED. DEVICE AVAILABILITY IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470394 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE ACCOUNT HAS AN ISSUE WITH ITEM 8695G. ALL THREE (3) BOXES HAVE THE ISSUE OF SUTURES BREAKING MIDCLOSURE. IN EACH BOX THERE ARE TWELVE (12) SUTURES. NO PATIENT HARM HAS BEEN REPORTED. DEVICE AVAILABILITY IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469991 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE ACCOUNT HAS AN ISSUE WITH ITEM 8695G. ALL THREE (3) BOXES HAVE THE ISSUE OF SUTURES BREAKING MIDCLOSURE. IN EACH BOX THERE ARE TWELVE (12) SUTURES. NO PATIENT HARM HAS BEEN REPORTED. DEVICE AVAILABILITY IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469975 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT SUTURES ARE BREAKING ONLY 8 OF 12. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24045760 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT SUTURES ARE BREAKING ONLY 8 OF 12. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24045743 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT SUTURES ARE BREAKING ONLY 8 OF 12. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24045739 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT SUTURES ARE BREAKING ONLY 8 OF 12. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24045696 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT SUTURES ARE BREAKING ONLY 8 OF 12. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24045684 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT SUTURES ARE BREAKING ONLY 8 OF 12. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24045672 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT SUTURES ARE BREAKING ONLY 8 OF 12. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24045656 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT SUTURES ARE BREAKING ONLY 8 OF 12. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24045627 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE AT THE SWAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21760675 ↗
• MalfunctionNov 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGY SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE IMMEDIATELY WHEN USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631184 ↗

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-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• 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

…and 6 more.