PROLENE M8805Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10705031046238), received between Apr 1, 2019 and Apr 6, 2026 — classified as 1 death, 38 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT DURING A VASCULAR PROCEDURE THE SURGEON WAS USING A SUTURE AND ATTEMPTED TO TIE A KNOT WITH NORMAL TENSION. AS HE CINCHED THE KNOT, THE SUTURE SNAPPED CLEANLY IN TWO. THE TEAM OPENED ANOTHER SUTURE AND THE SAME FAILURE OCCURRED; THIS ALSO HAPPENED WITH TWO ADDITIONAL SUTURES. THE FIRST ASSISTANT TRIED AS WELL, AND THAT SUTURE SNAPPED AS WELL. PRODUCT AVAILABILITY FOR RETURN IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790066 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT DURING A VASCULAR PROCEDURE THE SURGEON WAS USING A SUTURE AND ATTEMPTED TO TIE A KNOT WITH NORMAL TENSION. AS HE CINCHED THE KNOT, THE SUTURE SNAPPED CLEANLY IN TWO. THE TEAM OPENED ANOTHER SUTURE AND THE SAME FAILURE OCCURRED; THIS ALSO HAPPENED WITH TWO ADDITIONAL SUTURES. THE FIRST ASSISTANT TRIED AS WELL, AND THAT SUTURE SNAPPED AS WELL. PRODUCT AVAILABILITY FOR RETURN IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790065 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT DURING A VASCULAR PROCEDURE THE SURGEON WAS USING A SUTURE AND ATTEMPTED TO TIE A KNOT WITH NORMAL TENSION. AS HE CINCHED THE KNOT, THE SUTURE SNAPPED CLEANLY IN TWO. THE TEAM OPENED ANOTHER SUTURE AND THE SAME FAILURE OCCURRED; THIS ALSO HAPPENED WITH TWO ADDITIONAL SUTURES. THE FIRST ASSISTANT TRIED AS WELL, AND THAT SUTURE SNAPPED AS WELL. PRODUCT AVAILABILITY FOR RETURN IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790062 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT DURING A VASCULAR PROCEDURE THE SURGEON WAS USING A SUTURE AND ATTEMPTED TO TIE A KNOT WITH NORMAL TENSION. AS HE CINCHED THE KNOT, THE SUTURE SNAPPED CLEANLY IN TWO. THE TEAM OPENED ANOTHER SUTURE AND THE SAME FAILURE OCCURRED; THIS ALSO HAPPENED WITH TWO ADDITIONAL SUTURES. THE FIRST ASSISTANT TRIED AS WELL, AND THAT SUTURE SNAPPED AS WELL. PRODUCT AVAILABILITY FOR RETURN IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790060 ↗
• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN UNKNOWN CARDIOVASCULAR SURGERY, THE SUTURE WAS BROKEN DURING LIGATION, AND THIS ISSUE OCCURRED 2 PRODUCTS IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE.THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322467 ↗
• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6)2026 AND SUTURE WAS USED. DURING AN UNKNOWN CARDIOVASCULAR SURGERY, THE SUTURE WAS BROKEN DURING LIGATION, AND THIS ISSUE OCCURRED 2 PRODUCTS IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE.THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322428 ↗
• MalfunctionSep 23, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT DURING AN UNKNOWN CARDIOVASCULAR SURGERY, IT WAS NOT A CONTROL RELEASE NEEDLE. THE SUTURE WAS BROKEN AT A POINT WHERE THE DOCTOR WAS NOT OPERATING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20287752 ↗
• MalfunctionSep 16, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 SUTURE WAS USED. THE SUTURE HAD CUT DURING LIGATION. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224276 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING DEEP LIGATION, A FEW SUTURES WERE BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085019 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING DEEP LIGATION, A FEW SUTURES WERE BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085018 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING DEEP LIGATION, A FEW SUTURES WERE BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085017 ↗
• MalfunctionJul 15, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, 3 OF THE SUTURES WAS BROKEN. THE OPERATION TIME WAS NO EXTENSION. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19742700 ↗
• MalfunctionJul 15, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, 3 OF THE SUTURE WAS BROKEN. THE OPERATION TIME WAS NO EXTENSION. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19742697 ↗
• MalfunctionJul 15, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE, 3 OF THE SUTURE WAS BROKEN. THE OPERATION TIME WAS NO EXTENSION. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19742696 ↗
• MalfunctionMay 31, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE FELL OFF THE NEEDLE. THE NEEDLE WAS DETACHED FROM THE SUTURE WHEN TAKING OUT THE NEEDLE-SUTURE FROM THE PACKAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. ONE MORE NEEDLE WAS ALSO DETACHED IN THE SURGICAL FIELD. THE SUTURE METHOD WAS CONTINUOUS SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032715 ↗
• MalfunctionMar 30, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NORWOOD PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLES WERE BREAKING OFF. THEY WERE RETRIEVED AND THE CASE COMPLETED WITH NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16642744 ↗
• MalfunctionMar 2, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS EASILY DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16472555 ↗
• MalfunctionJan 11, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY PROCEDURE ON (B)(6) 2022 AND A SUTURE WAS USED. BEFORE OPENING THE PACKAGE, IT WAS FOUND THAT THE NEEDLE CAME OUT FROM THE PAPER FOLDER AND A PART OF THE NEEDLE WAS SEALED AT THE HEAT SEAL AREA. THE PACKAGE IS NOT DAMAGED AND THERE IS NO HOLE. HOWEVER, IT WOULD BE CAUSED BY MANUFACTURING PROCESS. OTHER PRODUCTS IN THE BOX WERE USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137772 ↗
• MalfunctionSep 8, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE AND THE NEEDLE WAS DETACHED FROM THE SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15382790 ↗
• MalfunctionSep 8, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE AND THE NEEDLE WAS DETACHED FROM THE SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15382662 ↗
• MalfunctionMar 9, 2022Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A PEDIATRIC CARDIOVASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING PROCEDURE THE SUTURES WERE 'FALLING OFF. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13714584 ↗
• MalfunctionNov 15, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS TO BE USED. DURING THE PROCEDURE, ONE OF THE NEEDLES IN THE SUTURE PACK WAS BLACK INSTEAD OF STAINLESS STEEL. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12813202 ↗
• MalfunctionAug 24, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE DISTRIBUTOR THAT A HAIR WAS FOUND IN THE PACKAGING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12363239 ↗
• DeathJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED TO SEAL A EMCO DURING THE BYPASS CASE. A PURSE STRING APPROACH WAS USED. THE PATIENT EXPIRED AT THE FACILITY. AUTOPSY SHOWED A BROKEN SUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 12088888 ↗
• MalfunctionJun 2, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES ARE FALLING OUT OF/OFF OF THE SYRINGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921104 ↗

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-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• 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-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• 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
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844

…and 6 more.