PROLENE F2832HRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031238046), received between May 9, 2019 and Jul 24, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE STRAND BROKE AT THE SAME AREA (5MM FROM THE CRIMPING AREA). THIS ISSUE OCCURRED WITH 6 DEVICES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SURGICAL DELAY OF 15 MINUTES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19816949 ↗
• MalfunctionMay 9, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A DENTAL PROCEDURE ON UNKNOWN DATE IN (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE BROKE DURING THE PASSAGE IN TISSUE BEFORE MAKING THE SECOND KNOT. ANOTHER DEVICE FROM COMPETITOR WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8597170 ↗
• MalfunctionMay 9, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A DENTAL PROCEDURE ON UNKNOWN DATE IN (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE BROKE DURING THE PASSAGE IN TISSUE BEFORE MAKING THE SECOND KNOT. ANOTHER DEVICE FROM COMPETITOR WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8597113 ↗
• MalfunctionMay 9, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A DENTAL PROCEDURE ON UNKNOWN DATE IN (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE BROKE DURING THE PASSAGE IN TISSUE BEFORE MAKING THE SECOND KNOT. ANOTHER DEVICE FROM COMPETITOR WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8597072 ↗
• MalfunctionMay 9, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A DENTAL PROCEDURE ON UNKNOWN DATE IN (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE BROKE DURING THE PASSAGE IN TISSUE BEFORE MAKING THE SECOND KNOT. ANOTHER DEVICE FROM COMPETITOR WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8597021 ↗
• MalfunctionMay 9, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A DENTAL PROCEDURE ON UNKNOWN DATE IN (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE BROKE DURING THE PASSAGE IN TISSUE BEFORE MAKING THE SECOND KNOT. ANOTHER DEVICE FROM COMPETITOR WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8596980 ↗
• MalfunctionMay 9, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A DENTAL PROCEDURE ON UNKNOWN DATE IN (B)(6)2019 AND SUTURE WAS USED. THE SUTURE BROKE DURING THE PASSAGE IN TISSUE BEFORE MAKING THE SECOND KNOT. ANOTHER DEVICE FROM COMPETITOR WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8596958 ↗

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-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647

…and 6 more.