PROLENE 8935HRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705031022089), received between Jun 15, 2021 and May 28, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (12 reports).

1 FDA recall record name this device's identifier, 1 still open.

20 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.

Recalls naming this device

1. Dec 20, 2024Open, Classified

   Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

   Z-1096-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DAT AND SUTURE WAS USED. SUSPECTED LOWER TENSILE STRENGTH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319390 ↗
• MalfunctionFeb 11, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. 4 SUTURES FLOSSED DURING THE SAME THORACIC OPERATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316738 ↗
• MalfunctionFeb 11, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2025 AND SUTURE WAS USED. 4 SUTURES FLOSSED DURING THE SAME THORACIC OPERATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316737 ↗
• MalfunctionFeb 11, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. 4 SUTURES FLOSSED DURING THE SAME THORACIC OPERATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316734 ↗
• MalfunctionFeb 11, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. 4 SUTURES FLOSSED DURING THE SAME THORACIC OPERATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316730 ↗
• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIAC PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE FRAYING DURING PROCEDURE. WHILE DOING SUTURE KNOTS THREAD BROKE. UNREPORTED REPEATED EPISODES REGARDING PROLENE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21081359 ↗
• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIAC PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE FRAYING DURING PROCEDURE. WHILE DOING SUTURE KNOTS THREAD BROKE. UNREPORTED REPEATED EPISODES REGARDING PROLENE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21081358 ↗
• MalfunctionJan 6, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIAC PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE FRAYING DURING PROCEDURE. WHILE DOING SUTURE KNOTS THREAD BROKE. UNREPORTED REPEATED EPISODES REGARDING PROLENE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21081357 ↗
• MalfunctionJan 6, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIAC PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE FRAYING DURING PROCEDURE. WHILE DOING SUTURE KNOTS THREAD BROKE. UNREPORTED REPEATED EPISODES REGARDING PROLENE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21081351 ↗
• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIAC PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE FRAYING DURING PROCEDURE. WHILE DOING SUTURE KNOTS THREAD BROKE. UNREPORTED REPEATED EPISODES REGARDING PROLENE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21081347 ↗
• MalfunctionJan 6, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIAC PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE FRAYING DURING PROCEDURE. WHILE DOING SUTURE KNOTS THREAD BROKE. UNREPORTED REPEATED EPISODES REGARDING PROLENE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21081343 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE FRAYING DURING PROCEDURE. WHILE DOING SUTURE KNOTS THREAD BROKE. UNREPORTED REPEATED EPISODES REGARDING PROLENE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21027514 ↗
• MalfunctionDec 27, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 03/12/2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE FRAYING DURING PROCEDURE. WHILE DOING SUTURE KNOTS THREAD BROKE. UNREPORTED REPEATED EPISODES REGARDING PROLENE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21027513 ↗
• MalfunctionDec 27, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE FRAYING DURING PROCEDURE. WHILE DOING SUTURE KNOTS THREAD BROKE. UNREPORTED REPEATED EPISODES REGARDING PROLENE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21027512 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE FRAYING DURING PROCEDURE. WHILE DOING SUTURE KNOTS THREAD BROKE. UNREPORTED REPEATED EPISODES REGARDING PROLENE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21027510 ↗
• MalfunctionJan 26, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THERE WERE SEVERAL THREADS THAT BROKE OFF FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13353565 ↗
• MalfunctionJan 26, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THERE WERE SEVERAL THREADS THAT BROKE OFF FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13353562 ↗
• MalfunctionJun 18, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNKNOWN ANASTOMOSIS SURGERY IN 2021 AND THE SUTURE WAS USED. THE SUTURE HAS BROKEN TWICE. THE PATIENT HAD TO HAVE ANOTHER STITCH IN VESSEL BECAUSE OF BREAKAGE. ANOTHER SUTURE REQUIRED IN VESSEL DUE TO BREAK. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12025922 ↗
• MalfunctionJun 15, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNKNOWN ANASTOMOSIS SURGERY IN 2021 AND THE SUTURE WAS USED. THE SUTURE HAS BROKEN TWICE. THE PATIENT HAD TO HAVE ANOTHER STITCH IN VESSEL BECAUSE OF BREAKAGE. ANOTHER SUTURE REQUIRED IN VESSEL DUE TO BREAK. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12002686 ↗
• MalfunctionJun 15, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNKNOWN ANASTOMOSIS SURGERY IN 2021 AND THE SUTURE WAS USED. THE SUTURE BROKE WHEN A SURGEON WAS TRYING TO TIE THE SUTURE. THE PATIENT HAD TO HAVE ANOTHER STITCH IN VESSEL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12002374 ↗
• MalfunctionJun 15, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNKNOWN ANASTOMOSIS SURGERY IN 2021 AND THE SUTURE WAS USED. THE NEEDLE SNAPPED FROM SUTURE WHEN A SURGEON WAS TRYING TO TIE THE SUTURE AFTER THE VESSEL WAS SUTURED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12002173 ↗

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-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031

…and 5 more.