PROLENE W295HRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705031238244), received between Jul 16, 2019 and Jun 24, 2026 — classified as 1 injury, 22 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, A NEEDLE TIP WAS FOUND TO BE MISSING AND COULD NOT BE LOCATED VISUALLY WITHIN THE OPERATIVE FIELD. PER PROTOCOL, AN INTRAOPERATIVE X-RAY WAS IMMEDIATELY OBTAINED. THE IMAGE REVEALED A SMALL RADIO-OPAQUE DOT, INDICATING THE LOCATION OF THE MISSING FRAGMENT. BASED ON THE X-RAY FINDINGS, THE SPECIFIC TISSUE WHERE THE DOT WAS LOCATED WAS EXCISED. A REPEAT X-RAY OF THE SURGICAL SITE WAS THEN PERFORMED. THE SECOND IMAGE CONFIRMED THAT THE RADIO-OPAQUE DOT WAS NO LONGER PRESENT, ENSURING THE FRAGMENT WAS SUCCESSFULLY REMOVED. ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 25607672 ↗
• MalfunctionJun 4, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON HAS RECENTLY EXPERIENCED A COUPLE OF PROLENE SNAP. ONE SNAPPED IN THE PRESENCE OF MY COLLEAGUE (WHO WAS SUPPORTING THE PROCEDURE FROM AN ENDOMECH PERSPECTIVE) AND SHE REPORTED IT TO ME ON BEHALF OF THE SURGEON. FURTHER SPECIFIC PROCEDURAL DETAILS TO FOLLOW. THE NEEDLE WAS CUT FROM THE THREAD AND THE THREAD WAS PLACED TOGETHER WITH THE SUTURE PACKET IN A BAG FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25391535 ↗
• MalfunctionJun 4, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON HAS RECENTLY EXPERIENCED A COUPLE OF PROLENE SNAP. ONE SNAPPED IN THE PRESENCE OF MY COLLEAGUE (WHO WAS SUPPORTING THE PROCEDURE FROM AN ENDOMECH PERSPECTIVE) AND SHE REPORTED IT TO ME ON BEHALF OF THE SURGEON. FURTHER SPECIFIC PROCEDURAL DETAILS TO FOLLOW. THE NEEDLE WAS CUT FROM THE THREAD AND THE THREAD WAS PLACED TOGETHER WITH THE SUTURE PACKET IN A BAG FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25391532 ↗
• MalfunctionDec 9, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILST USING THE PROLENE 2/0, THE THREAD HAS FRAYED WHILE USING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760257 ↗
• MalfunctionAug 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE HAS BEEN BREAKING IN THE MIDDLE WHILST WE HAVE BEEN USING IT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22794458 ↗
• MalfunctionMay 8, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE TIPS WERE COMING OFF THE NEEDLES AT AN UNKNOWN TIME. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19267371 ↗
• MalfunctionMay 8, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE TIPS WERE COMING OFF THE NEEDLES AT AN UNKNOWN TIME. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19267362 ↗
• MalfunctionMar 5, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SACROCOLPOPEXY PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. THE SUTURE BRANCHED OUT TO TWO STRANDS AFTER PULLING IN A ROBOTIC CASE. THE PROBLEM SUTURE WAS REMOVED WHICH CAUSED A 15 MINUTES OF DELAY TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841605 ↗
• MalfunctionMar 5, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SACROCOLPOPEXY PROCEDURE ON 2/15/2024; AND A SUTURE WAS USED. THE SUTURE BRANCHED OUT TO TWO STRANDS AFTER PULLING IN A ROBOTIC CASE. THE PROBLEM SUTURE WAS REMOVED WHICH CAUSED A 15 MINUTES OF DELAY TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841594 ↗
• MalfunctionMar 5, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SACROCOLPOPEXY PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. THE SUTURE BRANCHED OUT TO TWO STRANDS AFTER PULLING IN A ROBOTIC CASE. THE PROBLEM SUTURE WAS REMOVED WHICH CAUSED A 15 MINUTES OF DELAY TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841584 ↗
• MalfunctionMar 5, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SACROCOLPOPEXY PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. THE SUTURE BRANCHED OUT TO TWO STRANDS AFTER PULLING IN A ROBOTIC CASE. THE PROBLEM SUTURE WAS REMOVED WHICH CAUSED A 15 MINUTES OF DELAY TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841579 ↗
• MalfunctionMar 5, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SACROCOLPOPEXY PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. THE SUTURE BRANCHED OUT TO TWO STRANDS AFTER PULLING IN A ROBOTIC CASE. THE PROBLEM SUTURE WAS REMOVED WHICH CAUSED A 15 MINUTES OF DELAY TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841000 ↗
• MalfunctionMar 5, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SACROCOLPOPEXY PROCEDURE ON (B)(6) 2024 AND A SUTURE WAS USED. THE SUTURE BRANCHED OUT TO TWO STRANDS AFTER PULLING IN A ROBOTIC CASE. THE PROBLEM SUTURE WAS REMOVED WHICH CAUSED A 15 MINUTES OF DELAY TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18840477 ↗
• MalfunctionMar 5, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SACROCOLPOPEXY PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. THE SUTURE BRANCHED OUT TO TWO STRANDS AFTER PULLING IN A ROBOTIC CASE. THE PROBLEM SUTURE WAS REMOVED WHICH CAUSED A 15 MINUTES OF DELAY TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18840469 ↗
• MalfunctionMar 5, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SACROCOLPOPEXY PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. THE SUTURE BRANCHED OUT TO TWO STRANDS AFTER PULLING IN A ROBOTIC CASE. THE PROBLEM SUTURE WAS REMOVED WHICH CAUSED A 15 MINUTES OF DELAY TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18840468 ↗
• MalfunctionMar 5, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SACROCOLPOPEXY PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. THE SUTURE BRANCHED OUT TO TWO STRANDS AFTER PULLING IN A ROBOTIC CASE. THE PROBLEM SUTURE WAS REMOVED WHICH CAUSED A 15 MINUTES OF DELAY TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18840464 ↗
• MalfunctionMar 5, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SACROCOLPOPEXY PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. THE SUTURE BRANCHED OUT TO TWO STRANDS AFTER PULLING IN A ROBOTIC CASE. THE PROBLEM SUTURE WAS REMOVED WHICH CAUSED A 15 MINUTES OF DELAY TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18840450 ↗
• MalfunctionOct 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST MASS EXCISION BILATERAL WITH ROUND BLOCK MAMMOPLASTY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON USED PROLENE 2-0 ROUND THEN THE THREAD SUDDENLY SNAPPED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940677 ↗
• MalfunctionOct 5, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17877906 ↗
• MalfunctionMay 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, MHRA REPORTED APPROX 1-2MM OF END OF SUTURE NEEDLE BROKE OFF DURING USE. UNABLE TO LOCATE TIP. MHRA# 2022/012/007/501/023. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16947035 ↗
• MalfunctionJul 7, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING USE ON THE PATIENT THE NEEDLE TIP BROKE OFF DURING USE, APPROX. 1-2MM MISSING FROM THE END OF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14951412 ↗
• MalfunctionJul 16, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE IN 2019 UNDER LOCAL ANESTHETIC AND THE SUTURE WAS USED. DURING THE PROCEDURE, A NEEDLE TIP BROKE OFF WHILE SUTURING IN MESH DURING HERNIA REPAIR AND COULD NOT BE LOCATED. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. THE TIP WAS LOCATED AND RETRIEVED THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8792110 ↗
• MalfunctionJul 16, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE IN 2019 UNDER LOCAL ANESTHETIC AND THE SUTURE WAS USED. DURING THE PROCEDURE, A NEEDLE TIP BROKE OFF WHILE SUTURING IN MESH DURING HERNIA REPAIR AND COULD NOT BE LOCATED. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT HAD TO BE SENT FOR X-RAY TO ENSURE TIP WAS NOT PRESENT IN BODY. X-RAY CONFIRMATION WAS RECEIVED (B)(6) 2019 FROM X-RAY THAT NO TIP IS VISIBLE THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8792098 ↗

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-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• 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-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688

…and 6 more.