PROLENE 8707HRecalls & reported problems
Ethicon, LLC · Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture · Class 2 · Implant
Quick summary
This Ethicon Prolene 8707H is a blue polypropylene surgical suture used to close tissue during surgery. The 45 reports mostly describe the thread fraying, separating, or snapping during use, and needles popping or pulling off from the suture. No deaths and no injuries were reported, and no recalls name this device. Reports fell from 26 in the prior 12 months to none 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
- 45
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10705031019461), received between Mar 2, 2020 and Aug 18, 2025 — classified as 45 malfunctions.
The most frequently reported specific device problem is “Material Frayed” (21 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
- Material Frayed21
- Material Separation20
- Break7
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- No Consequences Or Impact To Patient5
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT A SUTURE BROKE FRI ¿ IT WAS AN 8707H 6-0 PROLENE THAT BROKE AT BOTH ENDS. WE DON¿T HAVE THE PACKAGING / LOT# AVAILABLE BUT WANTED TO REPORT THIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22827998 ↗MalfunctionJun 30, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR ANASTOMOSIS PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE PULL-OFF DURING TISSUE PASSAGE FROM SUTURE ON THE REINFORCEMENT ZONE. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. PROCEDURE FINISHED WITH SAME LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22366687 ↗MalfunctionMar 13, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. A NEEDLE COME OFF OF A SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21593407 ↗MalfunctionJan 24, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE OR MANAGEMENT HAS REPORTED TO ME THAT THE SUTURES IN THE BOX DETACHED FROM THE NEEDLES. THAT HAS BEEN THE CASE WITH 3 SUTURES THAT WERE OPENED.SHE GAVE THE BOX TO ME DURING A CONSIGNMENT VISIT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21232765 ↗MalfunctionJan 24, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE OR MANAGEMENT HAS REPORTED TO ME THAT THE SUTURES IN THE BOX DETACHED FROM THE NEEDLES. THAT HAS BEEN THE CASE WITH 3 SUTURES THAT WERE OPENED. SHE GAVE THE BOX TO ME DURING A CONSIGNMENT VISIT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21232763 ↗MalfunctionJan 24, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE OR MANAGEMENT HAS REPORTED TO ME THAT THE SUTURES IN THE BOX DETACHED FROM THE NEEDLES. THAT HAS BEEN THE CASE WITH 3 SUTURES THAT WERE OPENED. SHE GAVE THE BOX TO ME DURING A CONSIGNMENT VISIT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21232759 ↗MalfunctionDec 13, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES BREAK OFF BOTH NEEDLES. THE SUTURE BROKE IN THE MIDDLE NOT RIGHT AT THE END. DR. SAYS NO FORCE WAS APPLIED WHEN IT HAPPENED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20923716 ↗MalfunctionNov 20, 2024Material Separation; Defective Component; Material Separation; Defective Component
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES ARE DRY, AND THE NEEDLES ARE POPPING OFF. THEY SPENT 15 MINUTES SEARCHING THE FLOOR IN THE ROOM FOR ONE OF THE SUTURES THAT POPPED OFF TODAY. DR ASKED WHAT IS GOING TO BE DONE ABOUT THESE SUTURES, IT'S HAPPENING DAILY WITH MANY DIFFERENT LOT NUMBERS AND NOW EVEN 2 DIFFERENT NEEDLES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20736348 ↗MalfunctionNov 13, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED A HALF A BOX SUTURE HAS BEEN REMOVED FROM THE SHELF AS THE DOCTOR FOUND THAT EACH OF THE SUTURES WAS FRAYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20674716 ↗MalfunctionNov 13, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED A HALF A BOX SUTURE HAS BEEN REMOVED FROM THE SHELF AS THE DOCTOR FOUND THAT EACH OF THE SUTURES WAS FRAYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20674710 ↗MalfunctionNov 13, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED A HALF A BOX SUTURE HAS BEEN REMOVED FROM THE SHELF AS THE DOCTOR FOUND THAT EACH OF THE SUTURES WAS FRAYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20674663 ↗MalfunctionNov 13, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED A HALF A BOX SUTURE HAS BEEN REMOVED FROM THE SHELF AS THE DOCTOR FOUND THAT EACH OF THE SUTURES WAS FRAYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20674658 ↗MalfunctionNov 13, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED A HALF A BOX SUTURE HAS BEEN REMOVED FROM THE SHELF AS THE DOCTOR FOUND THAT EACH OF THE SUTURES WAS FRAYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20674630 ↗MalfunctionNov 13, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED A HALF A BOX SUTURE HAS BEEN REMOVED FROM THE SHELF AS THE DOCTOR FOUND THAT EACH OF THE SUTURES WAS FRAYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20674602 ↗MalfunctionNov 13, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED A HALF A BOX SUTURE HAS BEEN REMOVED FROM THE SHELF AS THE DOCTOR FOUND THAT EACH OF THE SUTURES WAS FRAYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20674556 ↗MalfunctionNov 13, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED A HALF A BOX SUTURE HAS BEEN REMOVED FROM THE SHELF AS THE DOCTOR FOUND THAT EACH OF THE SUTURES WAS FRAYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20674555 ↗MalfunctionNov 13, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED A HALF A BOX SUTURE HAS BEEN REMOVED FROM THE SHELF AS THE DOCTOR FOUND THAT EACH OF THE SUTURES WAS FRAYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20674536 ↗MalfunctionNov 13, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED A HALF A BOX SUTURE HAS BEEN REMOVED FROM THE SHELF AS THE DOCTOR FOUND THAT EACH OF THE SUTURES WAS FRAYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20674509 ↗MalfunctionNov 13, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED A HALF A BOX SUTURE HAS BEEN REMOVED FROM THE SHELF AS THE DOCTOR FOUND THAT EACH OF THE SUTURES WAS FRAYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20674497 ↗MalfunctionNov 13, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED A HALF A BOX SUTURE HAS BEEN REMOVED FROM THE SHELF AS THE DOCTOR FOUND THAT EACH OF THE SUTURES WAS FRAYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20674492 ↗MalfunctionNov 13, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED A HALF A BOX SUTURE HAS BEEN REMOVED FROM THE SHELF AS THE DOCTOR FOUND THAT EACH OF THE SUTURES WAS FRAYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20674482 ↗MalfunctionNov 13, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED A HALF A BOX SUTURE HAS BEEN REMOVED FROM THE SHELF AS THE DOCTOR FOUND THAT EACH OF THE SUTURES WAS FRAYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20674480 ↗MalfunctionNov 13, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED A HALF A BOX SUTURE HAS BEEN REMOVED FROM THE SHELF AS THE DOCTOR FOUND THAT EACH OF THE SUTURES WAS FRAYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20674479 ↗MalfunctionNov 13, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED A HALF A BOX SUTURE HAS BEEN REMOVED FROM THE SHELF AS THE DOCTOR FOUND THAT EACH OF THE SUTURES WAS FRAYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20674421 ↗MalfunctionNov 13, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED A HALF A BOX SUTURE HAS BEEN REMOVED FROM THE SHELF AS THE DOCTOR FOUND THAT EACH OF THE SUTURES WAS FRAYING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20674402 ↗
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-2448-2018 · May 7, 2018 · TerminatedPROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
- Z-2454-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
- Z-2464-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
- Z-2463-2018 · May 7, 2018 · TerminatedPROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
- Z-2461-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
- Z-2462-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
- Z-2460-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
- Z-2456-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
- Z-2449-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
- Z-2457-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
- Z-2452-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
- Z-2458-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
- Z-2455-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
…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.