PROLENE 8805HRecalls & reported problems
Ethicon, LLC · Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture · Class 2 · Implant
Quick summary
This Ethicon Prolene surgical suture has 212 adverse event reports, with 1 death and 1 injury. Most describe the thread breaking or separating during use, and most list no clinical signs in the patient. No recalls name this device.
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
- 209
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 209 adverse event reports that list this exact device (DI 10705031020672), received between Jul 23, 2018 and Aug 31, 2026 — classified as 1 death, 1 injury, 207 malfunctions.
The most frequently reported specific device problem is “Break” (113 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
- Break113
- Material Separation104
- Material Twisted/Bent7
- Component Incompatible2
- Delivered as Unsterile Product2
- Adverse Event Without Identified Device or Use Problem1
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions152
- No Consequences Or Impact To Patient55
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 209 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50518875 ↗MalfunctionAug 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50518856 ↗MalfunctionAug 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50518830 ↗MalfunctionAug 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50518829 ↗MalfunctionAug 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50518827 ↗MalfunctionAug 18, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50303315 ↗MalfunctionAug 18, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50303211 ↗MalfunctionAug 18, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50303163 ↗MalfunctionAug 18, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50302227 ↗MalfunctionAug 18, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50302211 ↗MalfunctionMay 28, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. SUTURE BREAKAGE REPEATEDLY OCCURRED WITH THE SAME LOT NUMBER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25322526 ↗MalfunctionMay 28, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. SUTURE BREAKAGE REPEATEDLY OCCURRED WITH THE SAME LOT NUMBER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25322522 ↗MalfunctionMay 12, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE DETACHED TO SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25152534 ↗MalfunctionMay 7, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 4/20/2026 AND SUTURE WAS USED. THE SUTURE STRING SNAPPED WHILE IN USE TWO TIMES. THEY DECIDED TO PULL THE BOX AFTER THE INCIDENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117232 ↗MalfunctionMay 7, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE STRING SNAPPED WHILE IN USE TWO TIMES. THEY DECIDED TO PULL THE BOX AFTER THE INCIDENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117218 ↗MalfunctionMay 1, 2026Break; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING SURGERY, 3 SUTURE NEEDLES BROKE OR PULLED OFF. THE SURGEON HAD TO RE-STITCH AN ILIO-FEMORAL THROMBECTOMY AND THE LOT WAS REMOVED FROM THE OPERATING ROOM.PATIENT CONSEQUENCES: NO. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055696 ↗MalfunctionMay 1, 2026Break; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING SURGERY, 3 SUTURE NEEDLES BROKE OR PULLED OFF. THE SURGEON HAD TO RE-STITCH AN ILIO-FEMORAL THROMBECTOMY AND THE LOT WAS REMOVED FROM THE OPERATING ROOM.PATIENT CONSEQUENCES: NO. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055695 ↗MalfunctionMay 1, 2026Break; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING SURGERY, 3 SUTURE NEEDLES BROKE OR PULLED OFF. THE SURGEON HAD TO RE-STITCH AN ILIO-FEMORAL THROMBECTOMY AND THE LOT WAS REMOVED FROM THE OPERATING ROOM. PATIENT CONSEQUENCES: NO. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055693 ↗MalfunctionApr 22, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN (B)(6) 2026 AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE, THE SURGEON PERFORMED TWO PROCEDURES CONSECUTIVELY USING THE SAME SUTURE. IN BOTH INSTANCES, AFTER TYING MULTIPLE KNOTS TO CLOSE A VEIN, THE SUTURE BROKE/SNAPPED. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24956929 ↗MalfunctionApr 22, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE, THE SURGEON PERFORMED TWO PROCEDURES CONSECUTIVELY USING THE SAME SUTURE. IN BOTH INSTANCES, AFTER TYING MULTIPLE KNOTS TO CLOSE A VEIN, THE SUTURE BROKE/SNAPPED. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24956926 ↗MalfunctionApr 20, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN AV FISTULA PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DOCTOR HAS OBSERVED THAT THE SUTURE GOT BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24926843 ↗MalfunctionApr 16, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A FEMORAL POPLITEAL BYPASS PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING A FEM-POP PROCEDURE, THE SUTURE BROKE DURING THE TYING, AND THE SURGEON WAS VERY UPSET. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24904217 ↗DeathMar 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SALES REP RECEIVED A CALL FROM THE ACCOUNT ASKING IF THERE WAS A RECALL REGARDING THIS PRODUCT CODE. THE CASE WAS DONE PREVIOUS TO THIS CALL AND NO ISSUES WERE REPORTED DURING THE CASE. THE PATIENT DEATH OCCURRED SOMETIME AFTER THE CASE WAS COMPLETED. NO PATIENT DETAILS, SYMPTOMS, DATES OR CAUSE OF DEATH WAS PROVIDED. THE SALES REP STATED THAT THE ACCOUNT WAS ASKING IF THERE WERE ANY RECALLS TO DO THEIR DUE DILIGENCE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24560547 ↗MalfunctionNov 17, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS EXPLAINED THAT NEEDLES WERE POPPING OFF PREMATURELY AND WERE NOT ABLE TO COMPLETE THE PROPER SUTURING NEEDED. DIFFERENT SUTURE WAS OPENED. PROCEDURE WAS DELAYED BY 5 MINUTES. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23575862 ↗MalfunctionNov 17, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS EXPLAINED THAT NEEDLES WERE POPPING OFF PREMATURELY AND WERE NOT ABLE TO COMPLETE THE PROPER SUTURING NEEDED. DIFFERENT SUTURE WAS OPENED. PROCEDURE WAS DELAYED BY 5 MINUTES. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23575850 ↗
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-2459-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
- Z-2450-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
- Z-2455-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
- Z-2449-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
- Z-2451-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
- 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-2460-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
- Z-2464-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
- Z-2466-2018 · May 7, 2018 · TerminatedPRONOVA SUTURE BLUE 122CM M1.5, D10189
- Z-2457-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
- 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
…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 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.