PROLENE EP8805HRecalls & reported problems
Ethicon, LLC · Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture · Class 2 · Implant
Quick summary
This Ethicon Prolene blue polypropylene surgical suture is used to close tissue during surgery. The 34 reports mostly describe the suture breaking mid-procedure, often right where the thread meets the needle, and sometimes the needle popping off or the material separating. No deaths or injuries are reported. There are no recalls naming this device.
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
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10705031208261), received between Apr 3, 2019 and Jan 22, 2026 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Break” (27 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
- Break27
- Material Separation5
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- No Consequences Or Impact To Patient3
- Blood Loss1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, DOCTOR WAS DOING CABG PROCEDURE WITH THE HELP OF PROLENE SUTURE BUT WHEN HE WAS USING EP8805, PROLENE 6-0 SUTURE SO SUDDENLY SUTURE GOT BREAKDOWN FROM SWAGE POINT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24153136 ↗MalfunctionJan 22, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, DOCTOR WAS DOING CABG PROCEDURE WITH THE HELP OF PROLENE SUTURE BUT WHEN HE WAS USING EP8805, PROLENE 6-0 SUTURE SO SUDDENLY SUTURE GOT BREAKDOWN FROM SWAGE POINT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24152906 ↗MalfunctionJan 15, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. WHEN DOING DISTAL ANASTOMOSIS WITH THE HELP OF SUTURE GOT BREAKDOWN FROM SWAGE POINT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24080842 ↗MalfunctionJan 15, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. WHEN DOING DISTAL ANASTOMOSIS WITH THE HELP OF SUTURE GOT BREAKDOWN FROM SWAGE POINT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24080840 ↗MalfunctionApr 25, 2025Defective Component; Defective Component
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THERE IS A SENSE OF DISCOMFORT TO THE SUTURE OF THE JOINT PART BETWEEN THE SUTURE AND NEEDLE (IT LOOKS LIKE IT IS SWOLLEN MORE THAN USUAL), SO THE USE WAS STOPPED FOR THE PATIENT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21909773 ↗MalfunctionAug 23, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE NEEDLE WHEN SUTURING. NO PATIENT CONSEQUENCE WAS REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20051889 ↗MalfunctionMay 6, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING SURGERY, TWO SUTURES WERE BROKEN. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19249059 ↗MalfunctionMay 6, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING SURGERY, TWO SUTURES WERE BROKEN. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19249054 ↗MalfunctionOct 16, 2023Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF OF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17942309 ↗MalfunctionApr 25, 2023Material Separation; Material Separation
IT WAS REPORTED A PATIENT UNDERWENT AN AORTIC PROSTHESIS PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. AFTER THE FIRST STITCH THROUGH THE AORTIC PROSTHESIS THE NEEDLE GETS STUCK AND PULLED OFF FROM THE SUTURE. NO PATIENT HARM BUT SURGICAL DELAY FROM 10 MINUTES. FINISHED THE PROCEDURE WITH SAME LIKE DEVICE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16811056 ↗MalfunctionSep 1, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15341262 ↗MalfunctionSep 1, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15341255 ↗MalfunctionSep 1, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15341212 ↗MalfunctionSep 1, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15341207 ↗MalfunctionSep 1, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15341171 ↗MalfunctionSep 1, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15341130 ↗MalfunctionAug 17, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15246572 ↗MalfunctionAug 17, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15246571 ↗MalfunctionAug 17, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15246569 ↗MalfunctionAug 17, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15246568 ↗MalfunctionAug 17, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15246567 ↗MalfunctionAug 17, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15246566 ↗MalfunctionAug 2, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE AND SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15150890 ↗MalfunctionAug 2, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE AND SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15150839 ↗MalfunctionAug 2, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE AND SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15150829 ↗
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-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-2466-2018 · May 7, 2018 · TerminatedPRONOVA SUTURE BLUE 122CM M1.5, D10189
- 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-2453-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
- Z-2462-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
- Z-2463-2018 · May 7, 2018 · TerminatedPROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
- Z-2456-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
- Z-2458-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
- Z-2461-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
- Z-2449-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
- Z-2451-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
…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.