PROLENE EPM8206Recalls & reported problems

Ethicon, LLC · PROLENE, POLYPROPYLENE (MONOFILAMENT) STERILE SYNTHETIC NON-ABSORBABLE SURGICAL SUTURE · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031203563), received between Nov 10, 2023 and Nov 10, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 10, 2023Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT THE SUTURES KEPT BREAKING. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18111707 ↗

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, Classified
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Z-1096-2025 · Dec 20, 2024 · Open, Classified
PROLENE 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 · Terminated
PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
Z-2453-2018 · May 7, 2018 · Terminated
PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
Z-2455-2018 · May 7, 2018 · Terminated
PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
Z-2451-2018 · May 7, 2018 · Terminated
PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
Z-2457-2018 · May 7, 2018 · Terminated
PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
Z-2460-2018 · May 7, 2018 · Terminated
PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
Z-2459-2018 · May 7, 2018 · Terminated
PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
Z-2450-2018 · May 7, 2018 · Terminated
PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
Z-2465-2018 · May 7, 2018 · Terminated
PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
Z-2448-2018 · May 7, 2018 · Terminated
PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
Z-2462-2018 · May 7, 2018 · Terminated
PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
Z-2456-2018 · May 7, 2018 · Terminated
PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
Z-2464-2018 · May 7, 2018 · Terminated
PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631

…and 6 more.

Device details

UDI-DI	`10705031203563`
Brand	PROLENE
Model	EPM8206
Company	Ethicon, LLC
Product code	GAW · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
Class	Class 2
FDA submission	K133356
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Sep 14, 2023

Device type (GMDN): Polyolefin/fluoropolymer suture, monofilament

A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices

PROLENE 8706H
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2 recalls294 reports
PROLENE 8702H
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PROLENE 8556H
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1 death240 reports
PROLENE 8805H
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1 death209 reports
PROLENE 8521H
Ethicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
3 deaths183 reports
PROLENE 8735H
Ethicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
163 reports
PROLENE 8711H
Ethicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
1 recall89 reports
PROLENE 9702H
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130 reports

All SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices →

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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