PROLENE EP8726HRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705031208278), received between Nov 6, 2019 and Feb 18, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE THREAD IS FRAYING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378946 ↗
• MalfunctionFeb 25, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS FRAYING AND THE KNOTS WERE FALLING APART AND BREAKING. THE CASE WAS COMPLETE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21460188 ↗
• MalfunctionFeb 25, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS FRAYING AND THE KNOTS WERE FALLING APART AND BREAKING. THE CASE WAS COMPLETE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21460186 ↗
• MalfunctionNov 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE WAS DISASSEMBLED FROM THE THREAD. THE SURGERY WAS DELAYED 5 MINUTES DUE TO THE REPORTED EVENT. A NEW SUTURE WAS USED WHEN THE EVENT OCCURRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND FRAGMENTS WERE NOT GENERATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20605099 ↗
• MalfunctionJun 11, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 17-APR-2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510842 ↗
• MalfunctionJun 11, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510841 ↗
• MalfunctionMay 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19298572 ↗
• MalfunctionJan 31, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE DETACHED COMPLETELY FROM THE SUTURE AFTER SINGLE PASS FROM THE TISSUE. ANOTHER LIKE DEVICE WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272564 ↗
• MalfunctionJan 31, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE DETACHED COMPLETELY FROM THE SUTURE AFTER SINGLE PASS FROM THE TISSUE. ANOTHER LIKE DEVICE WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272563 ↗
• MalfunctionDec 1, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 11/7/2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING USE. THE SAME THING HAPPENED FROM THE SAME BOX. SO THE SURGEON WANTS US TO CHANGE THE LOT NUMBER ITSELF. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15899378 ↗
• MalfunctionDec 1, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING USE. THE SAME THING HAPPENED FROM THE SAME BOX. SO THE SURGEON WANTS US TO CHANGE THE LOT NUMBER ITSELF. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15899269 ↗
• MalfunctionDec 1, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING USE. THE SAME THING HAPPENED FROM THE SAME BOX. SO THE SURGEON WANTS US TO CHANGE THE LOT NUMBER ITSELF. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15898679 ↗
• MalfunctionDec 3, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10938190 ↗
• MalfunctionJan 10, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CAROTID ARTERY REPAIR PROCEDURE ON (B)(6)2019 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS OPENED TO SUTURE A VESSEL BUT THE STRAND SNAPPED WHEN A SURGEON WAS TRYING TO SLIDE DOWN A KNOT. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9573651 ↗
• MalfunctionJan 10, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CAROTID ARTERY REPAIR PROCEDURE ON (B)(6) 2019 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS OPENED TO SUTURE A VESSEL BUT THE STRAND SNAPPED WHEN A SURGEON TRIED TO TIE A KNOT. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9573641 ↗
• MalfunctionNov 6, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9284171 ↗

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-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-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• 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-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031

…and 6 more.