PROLENE 8702HRecalls & reported problems
Ethicon, LLC · Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon Prolene suture is a blue synthetic stitching thread used in surgery. Reports most often describe the suture breaking, especially when tying knots, and needles coming loose from it. The database holds 243 reports, including 3 deaths and no injuries, with 240 malfunctions. No recalls name this device, and reports rose over the last year (43) compared with the year before (28).
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
- 254
- Deaths reported
- 3
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 254 adverse event reports that list this exact device (DI 10705031019324), received between Oct 31, 2018 and Sep 29, 2026 — classified as 3 deaths, 251 malfunctions.
The most frequently reported specific device problem is “Break” (160 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
- Break160
- Material Separation93
- Defective Component3
- Material Frayed3
- Separation Failure2
- Component Misassembled1
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions209
- No Consequences Or Impact To Patient42
- Perforation of Vessels3
Recent adverse event reports
The 25 most recent of 254 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933739 ↗MalfunctionSep 29, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933729 ↗MalfunctionSep 29, 2026Material Separation
It was reported that a patient underwent a cardiac procedure on (b)(6) 2026 and suture was used. During the procedure, the needle separated from the suture. A new box was opened and that one worked well. There were no adverse patient consequences. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933717 ↗MalfunctionSep 25, 2026Material Separation
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. Thread detached from sutures needle during procedure. There were no patient consequences reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900443 ↗MalfunctionSep 25, 2026Material Separation
It was reported that a patient underwent an unknown procedure on (b)(6)2026 and suture was used. Thread detached from sutures needle during procedure. There were no patient consequences reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900441 ↗MalfunctionSep 25, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900439 ↗MalfunctionSep 25, 2026Material Separation
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. Thread detached from sutures needle during procedure. There were no patient consequences reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900437 ↗MalfunctionSep 25, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900436 ↗MalfunctionSep 25, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900433 ↗MalfunctionSep 24, 2026Material Separation
It was reported a patient underwent a CABG procedure on (b)(6) 2026 and suture was used. The needle detached from the suture while the surgeon was attempting to place a stitch. No patient consequences were reported. The remaining sutures will be returning.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881520 ↗MalfunctionSep 24, 2026Material Separation
It was reported a patient underwent a CABG procedure on (b)(6) 2026 and suture was used. The needle detached from the suture while the surgeon was attempting to place a stitch. No patient consequences were reported. The remaining sutures will be returning.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881518 ↗MalfunctionJun 3, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE EASILY COME OUT FROM THE SUTURE. SUTURE BROKE EASILY WHEN TYING KNOTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25382304 ↗MalfunctionJun 3, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE EASILY COME OUT FROM THE SUTURE. SUTURE BROKE EASILY WHEN TYING KNOTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25382291 ↗MalfunctionJun 3, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE EASILY COME OUT FROM THE SUTURE. SUTURE BROKE EASILY WHEN TYING KNOTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25382281 ↗MalfunctionJun 3, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE EASILY COME OUT FROM THE SUTURE. SUTURE BROKE EASILY WHEN TYING KNOTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25382213 ↗MalfunctionJun 3, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE EASILY COME OUT FROM THE SUTURE. SUTURE BROKE EASILY WHEN TYING KNOTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25382178 ↗MalfunctionJun 3, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE EASILY COME OUT FROM THE SUTURE. SUTURE BROKE EASILY WHEN TYING KNOTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25382121 ↗MalfunctionMay 20, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6)2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE EASILY COME OUT FROM THE SUTURE. SUTURE BROKE EASILY WHEN TYING KNOTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25230232 ↗MalfunctionMay 15, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE WAS SNAPPED WHEN SURGEON WAS DOING DISTAL ANASTOMOSES FOR CABG PROCEDURE. THERE WERE NO SURGICAL DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25186178 ↗MalfunctionMay 15, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURE WAS SNAPPED WHEN SURGEON WAS DOING DISTAL ANASTOMOSES FOR CABG PROCEDURE. THERE WERE NO SURGICAL DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25186174 ↗MalfunctionApr 30, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE ACCOUNT CONTACT TO THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THE SUTURE LINES KEEPS BREAKING. NO PATIENT CONSEQUENCES. DEVICES WILL BE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25049581 ↗MalfunctionApr 30, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE ACCOUNT CONTACT TO THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THE SUTURE LINES KEEPS BREAKING. NO PATIENT CONSEQUENCES. DEVICES WILL BE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25047117 ↗MalfunctionApr 16, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. PROLENE 7/0 (8702H) SNAPPED AT SECOND BITE OF SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24897464 ↗MalfunctionApr 8, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. SUTURES SNAPPED AT SECOND BITE OF SUTURING. HAPPENED 4 TIMES IN 2 DAYS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SIGNIFICANT DELAYS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24815215 ↗MalfunctionApr 8, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2026 AND SUTURE WAS USED. SUTURES SNAPPED AT SECOND BITE OF SUTURING. HAPPENED 4 TIMES IN 2 DAYS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SIGNIFICANT DELAYS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24815214 ↗
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-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-2459-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
- Z-2463-2018 · May 7, 2018 · TerminatedPROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
- Z-2448-2018 · May 7, 2018 · TerminatedPROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
- Z-2460-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
- Z-2453-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
- 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-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-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
…and 6 more.
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices
- PROLENE 8706HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 recalls294 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
- PROLENE EP8735HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE128 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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