PROLENE 8807HRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10705031020719), received between Jun 19, 2019 and Jul 17, 2025 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Material Separation” (30 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN ANASTOMOSIS, THE NEEDLE PULLED OFF UPON THE PASSAGE OF THE ARTERIAL WALL. A COMPETITION DEVICE WAS USED FOR THE ANASTOMOSIS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531805 ↗
• MalfunctionJul 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN ANASTOMOSIS, THE NEEDLE PULLED OFF UPON THE PASSAGE OF THE ARTERIAL WALL. A COMPETITION DEVICE WAS USED FOR THE ANASTOMOSIS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531804 ↗
• MalfunctionJul 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN ANASTOMOSIS, THE NEEDLE PULLED OFF UPON THE PASSAGE OF THE ARTERIAL WALL. A COMPETITION DEVICE WAS USED FOR THE ANASTOMOSIS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531803 ↗
• MalfunctionApr 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, QUALITY ISSUE ON SUTURES, DETECTED DURING VASCULAR SURGERY: THE NEEDLE BECOMES LOOSE FROM THE THREAD ON SEVERAL UNITS. CONSEQUENCES: CONTINUOUS STITCH ON A PROSTHESIS - BLEEDING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21910147 ↗
• MalfunctionApr 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, QUALITY ISSUE ON SUTURES, DETECTED DURING VASCULAR SURGERY: THE NEEDLE BECOMES LOOSE FROM THE THREAD ON SEVERAL UNITS. CONSEQUENCES: CONTINOUS STITCH ON A PROSTHESIS - BLEEDING . NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21910146 ↗
• MalfunctionMar 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MANAGEMENT OF BILATERAL FEMORAL THROMBECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES OF THE PROLENE 6-0 SUTURE THREADS PULLED OFF. NO CONSEQUENCES FOR THE PATIENT. RISK OF BLEEDING AND RISK OF NEEDLE LOSS IN THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633730 ↗
• MalfunctionJan 31, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6)2024 AND SUTURE WAS USED. CRIMPING ISSUE THAT GAVE WAY DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285693 ↗
• MalfunctionJan 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID SURGERY IN (B)(6) 2025 AND SUTURE WAS USED. THE NODE GAVE WAY ON CAROTID SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285357 ↗
• MalfunctionJan 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE HAS PULLED OFF THE SUTURE. ANOTHER DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085412 ↗
• MalfunctionJan 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE HAS PULLED OFF THE SUTURE. ANOTHER DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085411 ↗
• MalfunctionJan 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE HAS PULLED OFF THE SUTURE. ANOTHER DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085408 ↗
• MalfunctionApr 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19129316 ↗
• MalfunctionMar 19, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE SURGEON USED A PROLENE WIRE, BUT ON SEVERAL OCCASIONS, THE THREAD BROKE AT THE SLIGHTEST PRESSURE (EVEN MINIMAL) AND THE NEEDLE PULLED OFF. AS A RESULT, THE STAFF HAD TO CHANGE THE BOX OF THREADS, WITH THE SAME REFERENCE NUMBER BUT UNKNOWN LOT NUMBER. THIS ISSUE CAUSED A LOSS OF SERVICE TIME. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18934253 ↗
• MalfunctionMar 19, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE SURGEON USED A PROLENE WIRE, BUT ON SEVERAL OCCASIONS, THE THREAD BROKE AT THE SLIGHTEST PRESSURE (EVEN MINIMAL) AND THE NEEDLE PULLED OFF. AS A RESULT, THE STAFF HAD TO CHANGE THE BOX OF THREADS, WITH THE SAME REFERENCE NUMBER BUT UNKNOWN LOT NUMBER. THIS ISSUE CAUSED A LOSS OF SERVICE TIME. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18934252 ↗
• MalfunctionMar 13, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THROMBOENDOARTERECTOMY (TEA) OF THE RIGHT CAROTID ARTERY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WANTING TO ANASTOMOSE THE CAROTID ARTERY, USED THE PROLENE WIRE. BUT ON SEVERAL OCCASIONS, THE THREADS BROKE AT THE SLIGHTEST PRESSURE (EVEN MINIMAL) AND THE NEEDLE PULLED OFF. AS A RESULT, THE STAFF HAD TO CHANGE THE BOX OF WIRES, WITH THE SAME REFERENCE NUMBER BUT UNKNOWN LOT NUMBER. THIS ISSUE CAUSED A LOSS OF TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18894249 ↗
• MalfunctionMar 13, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THROMBOENDOARTERECTOMY (TEA) OF THE RIGHT CAROTID ARTERY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WANTING TO ANASTOMOSE THE CAROTID ARTERY, USED THE PROLENE WIRE. BUT ON SEVERAL OCCASIONS, THE THREADS BROKE AT THE SLIGHTEST PRESSURE (EVEN MINIMAL) AND THE NEEDLE PULLED OFF. AS A RESULT, THE STAFF HAD TO CHANGE THE BOX OF WIRES, WITH THE SAME REFERENCE NUMBER BUT UNKNOWN LOT NUMBER. THIS ISSUE CAUSED A LOSS OF TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18894248 ↗
• MalfunctionMar 13, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THROMBOENDOARTERECTOMY (TEA) OF THE RIGHT CAROTID ARTERY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WANTING TO ANASTOMOSE THE CAROTID ARTERY, USED THE PROLENE WIRE. BUT ON SEVERAL OCCASIONS, THE THREADS BROKE AT THE SLIGHTEST PRESSURE (EVEN MINIMAL) AND THE NEEDLE PULLED OFF. AS A RESULT, THE STAFF HAD TO CHANGE THE BOX OF WIRES, WITH THE SAME REFERENCE NUMBER BUT UNKNOWN LOT NUMBER. THIS ISSUE CAUSED A LOSS OF TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18894240 ↗
• MalfunctionMar 13, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THROMBOENDOARTERECTOMY (TEA) OF THE RIGHT CAROTID ARTERY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WANTING TO ANASTOMOSE THE CAROTID ARTERY, USED THE PROLENE WIRE. BUT ON SEVERAL OCCASIONS, THE THREADS BROKE AT THE SLIGHTEST PRESSURE (EVEN MINIMAL) AND THE NEEDLE PULLED OFF. AS A RESULT, THE STAFF HAD TO CHANGE THE BOX OF WIRES, WITH THE SAME REFERENCE NUMBER BUT UNKNOWN LOT NUMBER. THIS ISSUE CAUSED A LOSS OF TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18894238 ↗
• MalfunctionMar 13, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THROMBOENDOARTERECTOMY (TEA) OF THE RIGHT CAROTID ARTERY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WANTING TO ANASTOMOSE THE CAROTID ARTERY, USED THE PROLENE WIRE. BUT ON SEVERAL OCCASIONS, THE THREADS BROKE AT THE SLIGHTEST PRESSURE (EVEN MINIMAL) AND THE NEEDLE PULLED OFF. AS A RESULT, THE STAFF HAD TO CHANGE THE BOX OF WIRES, WITH THE SAME REFERENCE NUMBER BUT UNKNOWN LOT NUMBER. THIS ISSUE CAUSED A LOSS OF TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18894235 ↗
• MalfunctionJul 7, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TEARS OFF THE THREAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14944880 ↗
• MalfunctionDec 22, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021 SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF OF THE THREAD. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13059411 ↗
• MalfunctionSep 23, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519587 ↗
• MalfunctionSep 23, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519586 ↗
• MalfunctionSep 23, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519580 ↗
• MalfunctionMay 26, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) OF 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SPLIT AND TORE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11889125 ↗

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-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844

…and 6 more.