PROLENE D9833Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031035126), received between Jul 11, 2023 and May 15, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (11 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS FRAYED AND THE DOCTOR FELT THAT THE SUTURE WAS BROKEN EASILY DURING SURGERY. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25190786 ↗
• MalfunctionMay 15, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS FRAYED AND THE DOCTOR FELT THAT THE SUTURE WAS BROKEN EASILY DURING SURGERY. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25190754 ↗
• MalfunctionMay 15, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS FRAYED AND THE DOCTOR FELT THAT THE SUTURE WAS BROKEN EASILY DURING SURGERY. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25190750 ↗
• MalfunctionMay 15, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS FRAYED AND THE DOCTOR FELT THAT THE SUTURE WAS BROKEN EASILY DURING SURGERY. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25190717 ↗
• MalfunctionMay 1, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS FRAYED AND THE DOCTOR FELT THAT THE SUTURE WAS BROKEN EASILY DURING SURGERY. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057525 ↗
• MalfunctionMay 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT TWO SUTURES BROKE WHILE SUTURING UNKNOWN TISSUE. A THIRD LIKE DEVICE FROM A NEW BOX WAS USED TO CONTINUE WITH THE PROCEDURE. UNKNOWN NUMBER OF STERILE SAMPLES RETURNING. EVENT DEVICES MAY BE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107363 ↗
• MalfunctionAug 29, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BENTALL PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE THICKNESS WRITTEN ON THE SURFACE IN THE PACKAGE (5-0) WAS DIFFERENT FROM THE DESCRIPTION INSIDE THE PACKAGE (6-0). NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17644593 ↗
• MalfunctionAug 29, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BENTALL PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. WHE SUTURE THICKNESS WRITTEN ON THE SURFACE IN THE PACKAGE (5-0) WAS DIFFERENT FROM THE DESCRIPTION INSIDE THE PACKAGE (6-0). NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17644588 ↗
• MalfunctionAug 29, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BENTALL PROCEDURE ON 8/7/2023 AND SUTURE WAS USED. THE SUTURE THICKNESS WRITTEN ON THE SURFACE IN THE PACKAGE (5-0) WAS DIFFERENT FROM THE DESCRIPTION INSIDE THE PACKAGE (6-0). NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17644583 ↗
• MalfunctionAug 16, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6)2023 AND SUTURE WAS USED. ALTHOUGH IT WAS 5-0, WHAT WAS PRINTED ON THE PACKAGE WAS THE NOTATION 6-0. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER EVENT DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557204 ↗
• MalfunctionAug 16, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. ALTHOUGH IT WAS 5-0, WHAT WAS PRINTED ON THE PACKAGE WAS THE NOTATION 6-0. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER EVENT DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557199 ↗
• MalfunctionAug 16, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. ALTHOUGH IT WAS 5-0, WHAT WAS PRINTED ON THE PACKAGE WAS THE NOTATION 6-0. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER EVENT DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557197 ↗
• MalfunctionAug 16, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. ALTHOUGH IT WAS 5-0, WHAT WAS PRINTED ON THE PACKAGE WAS THE NOTATION 6-0. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER EVENT DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557193 ↗
• MalfunctionAug 16, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. ALTHOUGH IT WAS 5-0, WHAT WAS PRINTED ON THE PACKAGE WAS THE NOTATION 6-0. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER EVENT DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557183 ↗
• MalfunctionAug 16, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. ALTHOUGH IT WAS 5-0, WHAT WAS PRINTED ON THE PACKAGE WAS THE NOTATION 6-0. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER EVENT DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557181 ↗
• MalfunctionAug 2, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE UNKNOWN SURGERY, THERE WAS A PRINTING ERROR ON THE PACKAGE. ALTHOUGH IT WAS 5-0, WHAT WAS PRINTED INSIDE THE OPENED PACKAGE WAS THE NOTATION 6-0. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17443353 ↗
• MalfunctionJul 11, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, AFTER OPENING THE PACKAGE, IT WAS FOUND THAT THERE WAS A PRINTING ERROR ON THE PACKAGE. ALTHOUGH THE PRODUCT WAS 5-0, WHAT WAS PRINTED WAS 6-0. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302681 ↗

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-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• 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-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292

…and 6 more.