PROLENE 8434HRecalls & reported problems
Ethicon, LLC · Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture · Class 2 · Implant
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031015593), received between Feb 20, 2020 and Jul 16, 2024 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Material Separation4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2024Break; Break
IT WAS REPORTED A PATIENT UNDERWENT A TOTAL MASTECTOMY, TAHBSO AND ABDOMINOPLASTY ON (B)(6) 2024 AND SUTURE WAS USED. DURING CASE, THE SUTURE BROKE FROM THE TIP OF THE NEEDLE. AND ACCORDING TO DR. THE SUTURE IS TOO FRAGILE, NEED TO REPLACE A NEW SUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19748870 ↗MalfunctionMay 9, 2023Break; Break
IT WAS REPORTED THAT AN ANIMAL UNDERWENT LARYNGEAL PARALYSIS SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. MULTIPLE NEEDLES BROKE DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16897000 ↗MalfunctionMay 9, 2023Break; Break
IT WAS REPORTED THAT AN ANIMAL UNDERWENT LARYNGEAL PARALYSIS SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. MULTIPLE NEEDLES BROKE DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16896996 ↗MalfunctionNov 12, 2021Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED WHEN KNOTTING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS DELAYED BY 10 MINUTES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12803674 ↗MalfunctionSep 14, 2020Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020, AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SEPARATED FROM THE NEEDLE AT THE SWAGE AFTER THE SURGICAL TECH LOADED THE NEEDLE. THE SURGERY WAS NOT DELAYED DUE TO THIS REPORTED EVENT. USED ANOTHER SUTURE CODE TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10527554 ↗MalfunctionSep 14, 2020Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SEPARATED FROM THE NEEDLE AT THE SWAGE AFTER THE SURGICAL TECH LOADED THE NEEDLE. THE SURGERY WAS NOT DELAYED DUE TO THIS REPORTED EVENT. USED ANOTHER SUTURE CODE TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10527552 ↗MalfunctionFeb 20, 2020Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED FOR WOUND CLOSURE. DURING THE PROCEDURE, THE DOCTOR WAS USING SUTURE TO CLOSE AN ABDOMINAL INCISION AND THE NEEDLE CAME OFF OF THE SUTURE, PREMATURELY. THE DOCTOR USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9732102 ↗MalfunctionFeb 20, 2020Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED FOR WOUND CLOSURE. DURING THE PROCEDURE, THE DOCTOR WAS USING SUTURE TO CLOSE AN ABDOMINAL INCISION AND THE NEEDLE CAME OFF OF THE SUTURE, PREMATURELY. THE DOCTOR USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9732100 ↗
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-2452-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
- Z-2460-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
- 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-2449-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
- Z-2456-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
- Z-2461-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
- Z-2459-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
- Z-2454-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
- Z-2455-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
- 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
- Z-2464-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
…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.