PROLENE 8683GRecalls & reported problems
Ethicon, LLC · Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture · Class 2 · Implant
Quick summary
This Ethicon Prolene 8683G is a blue polypropylene surgical suture, a non-absorbable stitch used to close tissue during surgery. All 29 reports describe the suture breaking, most often during the procedure itself, and 3 were filed as injuries; no deaths were reported. No recalls name this device, and no reports were filed in the past 12 months compared with 6 in the prior12 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
- 29
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10705031018914), received between Apr 30, 2019 and Jul 28, 2025 — classified as 3 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Break” (29 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
- Break29
Patient problems
- No Consequences Or Impact To Patient21
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE HAS BROKEN IN THREE PATIENTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22638963 ↗InjuryJul 28, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE HAS BROKEN IN THREE PATIENTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22634957 ↗InjuryJul 28, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE HAS BROKEN IN THREE PATIENTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22633100 ↗MalfunctionMay 29, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURES HAD BROKEN FOR THREE PATIENTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22106211 ↗MalfunctionMay 29, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURES HAD BROKEN FOR THREE PATIENTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22106180 ↗MalfunctionMay 29, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. SUTURES HAD BROKEN FOR THREE PATIENTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22106067 ↗MalfunctionDec 9, 2020Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10978007 ↗MalfunctionDec 9, 2020Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10977998 ↗MalfunctionApr 14, 2020Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BREAKING. PATIENT INVOLVEMENT WAS UNKNOWN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9957412 ↗MalfunctionFeb 5, 2020Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUTURE BROKE AT MANY DIFFERENT SPOTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9672942 ↗MalfunctionFeb 4, 2020Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2018 AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUTURE BROKE AT MANY DIFFERENT SPOTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9669109 ↗MalfunctionFeb 4, 2020Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUTURE BROKE AT MANY DIFFERENT SPOTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9669087 ↗MalfunctionFeb 4, 2020Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUTURE BROKE AT MANY DIFFERENT SPOTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9669072 ↗MalfunctionFeb 4, 2020Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2018 AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUTURE BROKE AT MANY DIFFERENT SPOTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9669033 ↗MalfunctionFeb 4, 2020Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2018 AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUTURE BROKE AT MANY DIFFERENT SPOTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9668950 ↗MalfunctionFeb 4, 2020Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUTURE BROKE AT MANY DIFFERENT SPOTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9668933 ↗MalfunctionFeb 4, 2020Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUTURE BROKE AT MANY DIFFERENT SPOTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9668905 ↗MalfunctionDec 20, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A BIOPSY PROCEDURE IN 2019 AND THE SUTURE WAS USED FOR EXCISION. DURING THE SURGERY, THE SUTURE BROKE AT SPOT ALONG THE BLUE NYLON. THERE IS NO SPECIFIC AREA OF THE BODY WHERE BREAKAGE HAS OCCURRED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9501620 ↗MalfunctionDec 20, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A BIOPSY PROCEDURE IN 2019 AND THE SUTURE WAS USED FOR EXCISION. DURING THE SURGERY, THE SUTURE BROKE AT SPOT ALONG THE BLUE NYLON. THERE IS NO SPECIFIC AREA OF THE BODY WHERE BREAKAGE HAS OCCURRED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9501607 ↗MalfunctionDec 20, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A BIOPSY PROCEDURE IN 2019 AND THE SUTURE WAS USED FOR EXCISION. DURING THE SURGERY, THE SUTURE BROKE AT SPOT ALONG THE BLUE NYLON. THERE IS NO SPECIFIC AREA OF THE BODY WHERE BREAKAGE HAS OCCURRED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9501601 ↗MalfunctionDec 20, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A BIOPSY PROCEDURE IN 2019 AND THE SUTURE WAS USED FOR EXCISION. DURING THE SURGERY, THE SUTURE BROKE AT SPOT ALONG THE BLUE NYLON. THERE IS NO SPECIFIC AREA OF THE BODY WHERE BREAKAGE HAS OCCURRED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9501600 ↗MalfunctionDec 20, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A BIOPSY PROCEDURE IN 2019 AND THE SUTURE WAS USED FOR EXCISION. DURING THE SURGERY, THE SUTURE BROKE AT SPOT ALONG THE BLUE NYLON. THERE IS NO SPECIFIC AREA OF THE BODY WHERE BREAKAGE HAS OCCURRED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9501589 ↗MalfunctionDec 20, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A BIOPSY PROCEDURE IN 2019 AND THE SUTURE WAS USED FOR EXCISION. DURING THE SURGERY, THE SUTURE BROKE AT SPOT ALONG THE BLUE NYLON. THERE IS NO SPECIFIC AREA OF THE BODY WHERE BREAKAGE HAS OCCURRED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9501588 ↗MalfunctionSep 3, 2019Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE THAT BROKE WHILE SUTURING WAS OCCURRING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8956347 ↗MalfunctionSep 3, 2019Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE THAT BROKE WHILE SUTURING WAS OCCURRING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8956345 ↗
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-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-2453-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
- Z-2455-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
- Z-2452-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
- Z-2451-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
- Z-2456-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
- Z-2464-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
- Z-2458-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
- Z-2450-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
- Z-2465-2018 · May 7, 2018 · TerminatedPRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
- Z-2459-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
- Z-2462-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
…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.