PROLENE 8718HRecalls & 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
- 28
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10705031019652), received between Dec 27, 2019 and Sep 1, 2026 — classified as 1 injury, 27 malfunctions.
The most frequently reported specific device problem is “Break” (20 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
- Break20
- Material Separation4
- Material Frayed3
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient3
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542474 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542461 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542452 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542391 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542388 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542384 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542381 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542379 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542376 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542370 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542367 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542362 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542360 ↗MalfunctionMay 5, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A TAVR PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REPRESENTATIVE THAT DURING A TAVR PROCEDURE, BOTH DEVICES EXPERIENCED BREAKAGE. A DEVICE FROM A DIFFERENT LOT WAS OBTAINED AND USED TO COMPLETE THE PROCEDURE. DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25082594 ↗InjuryMar 7, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE STITCH HAD BROKEN AND THE PATIENT HAD TO GO BACK FOR IT TO BE REPAIRED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21548543 ↗MalfunctionNov 27, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED, DURING THE PROCEDURE, IT WAS FOUND THAT THERE HAD BEEN A FOREIGN BLACK MATTER IN THE STERILIZATION PACKAGE THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20795662 ↗MalfunctionAug 27, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY ROBOTIC PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES BROKE OFF, THE NEEDLES FELL RIGHT OFF. WENT THROUGH FOUR OF ONE LOT NUMBER AND ONE OF ANOTHER LOT NUMBER. CASE WAS COMPLETED. NO PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20077025 ↗MalfunctionMar 20, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIAC PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED WHILE SUTURING UNKNOWN TISSUE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18942401 ↗MalfunctionMar 20, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIAC PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED WHILE SUTURING UNKNOWN TISSUE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18942400 ↗MalfunctionMar 20, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIAC PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED WHILE SUTURING UNKNOWN TISSUE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18942399 ↗MalfunctionMay 4, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A WHIPPLE PROCEDURE ON (B)(6) 2022. AND SUTURE WAS USED. THE SUTURE BROKE WHEN USED AS AN EMERGENCY STICH. THE NURSING STAFF HAVE REPORTED THAT THE PHYSICIAN USING THE SUTURE, IS AN EXPERIENCED SURGEON WHO WOULD BE VERY FAMILIAR WITH THE SUTURE BREAKING TENSION, AND THE THAT THE FAULT IN FACT LIES WITH THE SUTURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14280728 ↗MalfunctionMay 4, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A WHIPPLE PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE WHEN USED AS AN EMERGENCY STITCH. THE NURSING STAFF HAVE REPORTED THAT THE PHYSICIAN USING THE SUTURE, IS AN EXPERIENCED SURGEON WHO WOULD BE VERY FAMILIAR WITH THE SUTURE BREAKING TENSION, AND THE THAT THE FAULT IN FACT LIES WITH THE SUTURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14280672 ↗MalfunctionFeb 28, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A AV FISTULA ON (B)(6) 2022 AND SUTURE WAS USED. DURING USE ON THE PATIENT IT WAS NOTED THAT THE NEEDLE BROKE IN HALF. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13625613 ↗MalfunctionFeb 28, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A AV FISTULA ON (B)(6) 2022 AND SUTURE WAS USED. DURING USE ON THE PATIENT IT WAS NOTED THAT THE NEEDLE BROKE IN HALF. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13625590 ↗MalfunctionFeb 28, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A AV FISTULA ON (B)(6) 2022 AND SUTURE WAS USED. DURING USE ON THE PATIENT IT WAS NOTED THAT THE NEEDLE BROKE IN HALF. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13625556 ↗
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-2464-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
- Z-2459-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
- Z-2460-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
- Z-2463-2018 · May 7, 2018 · TerminatedPROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
- 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-2462-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
- Z-2453-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
- Z-2457-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
- 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-2452-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
- 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 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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