PROLENE EH7255HRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031095700), received between Nov 24, 2020 and Jul 16, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING SUTURING OF VESSELS, SUTURE BREAKAGE OCCURRED. THE PROCEDURE WAS COMPLETED USING A NEW LIKE DEVICE AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12180842 ↗
• MalfunctionJul 16, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING SUTURING OF VESSELS, SUTURE BREAKAGE OCCURRED. THE PROCEDURE WAS COMPLETED USING A NEW LIKE DEVICE AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12180837 ↗
• MalfunctionJul 16, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING SUTURING OF VESSELS, SUTURE BREAKAGE OCCURRED. THE PROCEDURE WAS COMPLETED USING A NEW LIKE DEVICE AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12180832 ↗
• MalfunctionNov 24, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. IT WAS ALSO REPORTED THAT THE NEEDLE PULL-OFF OCCURRED DURING TISSUE PASSAGE. ANOTHER LIKE SUTURE FROM DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10892875 ↗
• MalfunctionNov 24, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. IT WAS ALSO REPORTED THAT THE NEEDLE PULL-OFF OCCURRED DURING TISSUE PASSAGE. ANOTHER LIKE SUTURE FROM DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10892871 ↗
• MalfunctionNov 24, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A VASCULAR PROCEDURE ON 10/31/2020 AND THE SUTURE WAS USED. IT WAS ALSO REPORTED THAT THE NEEDLE PULL-OFF OCCURRED DURING TISSUE PASSAGE. ANOTHER LIKE SUTURE FROM DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10892816 ↗

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-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• 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
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844

…and 6 more.