PROLENE 8455HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031015869), received between Sep 6, 2019 and May 21, 2025 — 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.

• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED, DURING A SPINE WASH OUT, WHILE USING THE SUTURE. THE TIP BROKE OFF. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE WHICH WORKED OUT FOR THEM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062043 ↗
• MalfunctionFeb 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COLON RESECTION ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE RIGHT OFF WHEN USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11266454 ↗
• MalfunctionFeb 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COLON RESECTION ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE RIGHT OFF WHEN USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11266448 ↗
• MalfunctionFeb 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COLON RESECTION ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE RIGHT OFF WHEN USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11266446 ↗
• MalfunctionSep 6, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR PROCEDURE ON (B)(6)2019 AND SUTURE WAS USED. THE SUTURE WAS USED TO SECURE THE MESH. THE NEEDLE PASSED THROUGH THE MESH BUT EXITED THE OTHER SIDE WITH A LONGITUDINAL SPLIT IN THE SUTURE FOR MOST OF ITS LENGTH. ANOTHER DEVICE OF THE SAME BATCH WAS USED TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY TO SURGERY TIME. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8971470 ↗

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-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• 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-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• 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

…and 6 more.