PROLENE EP8746HRecalls & reported problems
Ethicon, LLC · Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705031206687), received between Jan 30, 2020 and May 15, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Break” (11 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
- Break11
- Material Separation4
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIAC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. CARDIAC OR NURSE REPORTED THAT IN CASE OF ONE SUTURE THE NEEDLE WAS OFF ALREADY IN THE PACKAGE; IN CASE OF OTHER SUTURE THE NEEDLE CAME OFF DURING PROCEDURE. IN TOTAL 2 SUTURES WERE DEFECTIVE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25187449 ↗MalfunctionMay 9, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE IS BREAKING DURING SURGERY. THEY HAVE OPENED SEVERAL BOXES AND TRIED WITH NEW SUTURE AND IT IS THE SAME ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14343112 ↗MalfunctionMay 9, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE IS BREAKING DURING SURGERY. THEY HAVE OPENED SEVERAL BOXES AND TRIED WITH NEW SUTURE AND IT IS THE SAME ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14343111 ↗MalfunctionMay 9, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE IS BREAKING DURING SURGERY. THEY HAVE OPENED SEVERAL BOXES AND TRIED WITH NEW SUTURE AND IT IS THE SAME ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14343110 ↗MalfunctionMay 9, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE IS BREAKING DURING SURGERY. THEY HAVE OPENED SEVERAL BOXES AND TRIED WITH NEW SUTURE AND IT IS THE SAME ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14343109 ↗MalfunctionMay 9, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE IS BREAKING DURING SURGERY. THEY HAVE OPENED SEVERAL BOXES AND TRIED WITH NEW SUTURE AND IT IS THE SAME ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14343108 ↗MalfunctionMay 9, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE IS BREAKING DURING SURGERY. THEY HAVE OPENED SEVERAL BOXES AND TRIED WITH NEW SUTURE AND IT IS THE SAME ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14343107 ↗MalfunctionMay 9, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE IS BREAKING DURING SURGERY. THEY HAVE OPENED SEVERAL BOXES AND TRIED WITH NEW SUTURE AND IT IS THE SAME ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14343106 ↗MalfunctionMay 9, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE IS BREAKING DURING SURGERY. THEY HAVE OPENED SEVERAL BOXES AND TRIED WITH NEW SUTURE AND IT IS THE SAME ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14343104 ↗MalfunctionMay 9, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE IS BREAKING DURING SURGERY. THEY HAVE OPENED SEVERAL BOXES AND TRIED WITH NEW SUTURE AND IT IS THE SAME ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14343103 ↗MalfunctionMay 9, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE IS BREAKING DURING SURGERY. THEY HAVE OPENED SEVERAL BOXES AND TRIED WITH NEW SUTURE AND IT IS THE SAME ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14343102 ↗MalfunctionJan 30, 2020Material Separation; Material Separation
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE DETACHED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9649520 ↗MalfunctionJan 30, 2020Material Separation; Material Separation
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE DETACHED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9649519 ↗MalfunctionJan 30, 2020Material Separation; Material Separation
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE DETACHED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9649517 ↗MalfunctionJan 30, 2020Material Separation; Material Separation
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE DETACHED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9649515 ↗
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-2465-2018 · May 7, 2018 · TerminatedPRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
- Z-2450-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
- Z-2461-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
- Z-2456-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
- Z-2451-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
- Z-2453-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
- Z-2452-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
- Z-2449-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
- Z-2462-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
- Z-2455-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
- Z-2463-2018 · May 7, 2018 · TerminatedPROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
- Z-2460-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
…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 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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