PROLENE EP8704SLHRecalls & reported problems
Ethicon, LLC · Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture · Class 2 · Implant
Quick summary
This Ethicon Prolene blue polypropylene surgical suture is a nonabsorbable stitching thread used to close tissue during surgery. The 50 reports mostly describe the thread breaking during an operation, or the needle coming apart from the suture where it is crimped on, which sometimes delayed surgery; no patient injuries were described. There are no deaths or injuries among the reports and no recalls name this device. Reports rose sharply, from 5 in the prior 12 months to 42 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10705031206144), received between Jul 11, 2024 and May 4, 2026 — classified as 49 malfunctions.
The most frequently reported specific device problem is “Break” (33 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.
Reports received per month
Most reported problems
Device problems
- Break33
- Material Separation16
Patient problems
- No Clinical Signs, Symptoms or Conditions49
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING SURGERY, COMPLAINED THAT WHILE USING SUTURE, THE NEEDLE GOT SEPERATED FROM THE SUTURE MATERIAL FROM THE SWAGE POINT DURING THE FIRST BYTE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25073553 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699982 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699958 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699954 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699949 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699934 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699931 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699927 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699925 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699924 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699923 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699886 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699884 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699881 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699877 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699868 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699855 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699852 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699770 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699768 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699762 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699755 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699736 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699733 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE BREAKAGE DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699729 ↗
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, ClassifiedPROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
- Z-1096-2025 · Dec 20, 2024 · Open, ClassifiedPROLENE 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-2456-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
- Z-2450-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
- Z-2463-2018 · May 7, 2018 · TerminatedPROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
- Z-2465-2018 · May 7, 2018 · TerminatedPRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
- Z-2466-2018 · May 7, 2018 · TerminatedPRONOVA SUTURE BLUE 122CM M1.5, D10189
- Z-2454-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
- Z-2451-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
- Z-2452-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
- Z-2464-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
- Z-2460-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
- Z-2448-2018 · May 7, 2018 · TerminatedPROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
- Z-2459-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
- Z-2457-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
…and 6 more.
Other Suture, nonabsorbable, synthetic, polypropylene devices
- PROLENE 8706HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 recalls294 reports
- PROLENE 8702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths254 reports
- PROLENE 8556HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death240 reports
- PROLENE 8805HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death209 reports
- PROLENE 8521HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths183 reports
- PROLENE 8735HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE163 reports
- PROLENE 8711HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall89 reports
- PROLENE 9702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE130 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.