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PROLENE OSM8738Recalls & 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
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031231252), received between Apr 20, 2020 and Apr 20, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

Most reported problems

Device problems

  • Break5

Patient problems

  • No Consequences Or Impact To Patient5

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 20, 2020Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS SURGERY ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING VASCULAR ANASTOMOSIS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9978372 ↗
  • MalfunctionApr 20, 2020Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS SURGERY ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING VASCULAR ANASTOMOSIS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9978368 ↗
  • MalfunctionApr 20, 2020Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS SURGERY ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING VASCULAR ANASTOMOSIS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9978365 ↗
  • MalfunctionApr 20, 2020Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS SURGERY ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING VASCULAR ANASTOMOSIS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9978357 ↗
  • MalfunctionApr 20, 2020Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS SURGERY ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING VASCULAR ANASTOMOSIS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9978351 ↗

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-2462-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
  • Z-2453-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
  • Z-2463-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
  • Z-2451-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
  • Z-2450-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
  • Z-2448-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
  • Z-2460-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
  • Z-2466-2018 · May 7, 2018 · Terminated
    PRONOVA SUTURE BLUE 122CM M1.5, D10189
  • Z-2459-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
  • Z-2464-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
  • Z-2456-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
  • Z-2458-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
  • Z-2449-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981

…and 6 more.

Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices

All SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices →

Sources and updates

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