PROLENE EPH7477HRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10705031233454), received between Aug 22, 2019 and Apr 17, 2025 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT IT IS A RECURRENT ISSUE: THE NEEDLE LOOSENED DURING USE. THIS IS A REPETITIVE INCIDENT IN THE SERVICE, AS THIS PROBLEM OCCURS ALMOST EVERY TIME THERE IS AN INTERVENTION. THIS DETACHMENT ISSUE SEEMS TO BE SPECIFIC TO THIS REFERENCE, WHICH REPLACES THE ONE USUALLY USED IN THE SERVICE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859565 ↗
• MalfunctionApr 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. AT THE CCV BLOCK, THE NEEDLE LOOSENED DURING USE. A SECOND THREAD WAS USED TO COMPLETE THE GESTURE. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859529 ↗
• MalfunctionDec 17, 2024Break; Material Separation; Material Twisted/Bent; Break; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP IS REPORTING THAT THE SUTURE IS BREAKING AT TIMES ALONG WITH THE NEEDLES POPPING OFF AND BENDING WHEN PASSING THROUGH. THEY HAD TO KEEP USING MORE UNTIL IT WORKED TO COMPLETE THE CASE. NEEDLES DID NOT FALL INTO THE PATIENT AND THERE WAS NO PATIENT HARM REPORTED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20951496 ↗
• MalfunctionDec 17, 2024Break; Material Separation; Material Twisted/Bent; Break; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP IS REPORTING THAT THE SUTURE IS BREAKING AT TIMES ALONG WITH THE NEEDLES POPPING OFF AND BENDING WHEN PASSING THROUGH. THEY HAD TO KEEP USING MORE UNTIL IT WORKED TO COMPLETE THE CASE. NEEDLES DID NOT FALL INTO THE PATIENT AND THERE WAS NO PATIENT HARM REPORTED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20951483 ↗
• MalfunctionOct 31, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BREAKAGE OCCURRED A LOT OF TIMES AND THE SUTURE DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582867 ↗
• MalfunctionOct 31, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BREAKAGE OCCURRED A LOT OF TIMES AND THE SUTURE DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582824 ↗
• MalfunctionOct 31, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BREAKAGE OCCURRED A LOT OF TIMES AND THE SUTURE DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582801 ↗
• MalfunctionOct 31, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BREAKAGE OCCURRED A LOT OF TIMES AND THE SUTURE DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582770 ↗
• MalfunctionOct 31, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BREAKAGE OCCURRED A LOT OF TIMES AND THE SUTURE DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582766 ↗
• MalfunctionOct 31, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BREAKAGE OCCURRED A LOT OF TIMES AND THE SUTURE DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582737 ↗
• MalfunctionJul 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT HAS BEEN NOTICED THAT THE THREADS BREAK WITH EACH USE JUST UNDER THE NEEDLE OR IN THE MIDDLE OF THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730391 ↗
• MalfunctionJul 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT HAS BEEN NOTICED THAT THE THREADS BREAK WITH EACH USE JUST UNDER THE NEEDLE OR IN THE MIDDLE OF THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715753 ↗
• MalfunctionJul 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT HAS BEEN NOTICED THAT THE THREADS BREAK WITH EACH USE JUST UNDER THE NEEDLE OR IN THE MIDDLE OF THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715664 ↗
• MalfunctionJul 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT HAS BEEN NOTICED THAT THE THREADS BREAK WITH EACH USE JUST UNDER THE NEEDLE OR IN THE MIDDLE OF THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715656 ↗
• MalfunctionJul 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT HAS BEEN NOTICED THAT THE THREADS BREAK WITH EACH USE JUST UNDER THE NEEDLE OR IN THE MIDDLE OF THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715486 ↗
• MalfunctionJul 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT HAS BEEN NOTICED THAT THE THREADS BREAK WITH EACH USE JUST UNDER THE NEEDLE OR IN THE MIDDLE OF THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715263 ↗
• MalfunctionJul 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT HAS BEEN NOTICED THAT THE THREADS BREAK WITH EACH USE JUST UNDER THE NEEDLE OR IN THE MIDDLE OF THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715247 ↗
• MalfunctionJul 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT HAS BEEN NOTICED THAT THE THREADS BREAK WITH EACH USE JUST UNDER THE NEEDLE OR IN THE MIDDLE OF THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715134 ↗
• MalfunctionJul 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT HAS BEEN NOTICED THAT THE THREADS BREAK WITH EACH USE JUST UNDER THE NEEDLE OR IN THE MIDDLE OF THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715115 ↗
• MalfunctionJul 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT HAS BEEN NOTICED THAT THE THREADS BREAK WITH EACH USE JUST UNDER THE NEEDLE OR IN THE MIDDLE OF THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715114 ↗
• MalfunctionJul 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT HAS BEEN NOTICED THAT THE THREADS BREAK WITH EACH USE JUST UNDER THE NEEDLE OR IN THE MIDDLE OF THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715113 ↗
• MalfunctionOct 28, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020, AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10748470 ↗
• MalfunctionAug 22, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAROTID ARTERY REPAIR ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE FRAYED WHEN PASSING THROUGH THE VASCULAR PROSTHESIS. THE SUTURE WAS CHANGED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8923681 ↗
• MalfunctionAug 22, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAROTID ARTERY REPAIR ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE FRAYED WHEN PASSING THROUGH THE VASCULAR PROSTHESIS. THE SUTURE WAS CHANGED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8923680 ↗
• MalfunctionAug 22, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAROTID ARTERY REPAIR ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE FRAYED WHEN PASSING THROUGH THE VASCULAR PROSTHESIS. THE SUTURE WAS CHANGED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8923679 ↗

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-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• 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-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688

…and 6 more.