PROLENE 8725HRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10705031019799), received between Dec 23, 2019 and Jul 15, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Material Separation” (15 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25829638 ↗
• MalfunctionMay 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT SUTURE WAS SNAPPED OFF THE NEEDLE DURING PROCEDURE. NO DELAY OR PATIENT HARM WAS REPORTED. DEVICE WAS DISCARDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230810 ↗
• MalfunctionApr 22, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON OBSERVED TINY MICROFIBERS SHEDDING FROM THE SUTURE MATERIAL. AS A PRECAUTIONARY MEASURE, THE HOSPITAL INITIATED AND DOCUMENTED A SAFETY INCIDENT IN ACCORDANCE WITH INTERNAL REPORTING PROTOCOLS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957565 ↗
• MalfunctionApr 22, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON OBSERVED TINY MICROFIBERS SHEDDING FROM THE SUTURE MATERIAL. AS A PRECAUTIONARY MEASURE, THE HOSPITAL INITIATED AND DOCUMENTED A SAFETY INCIDENT IN ACCORDANCE WITH INTERNAL REPORTING PROTOCOLS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957562 ↗
• MalfunctionApr 22, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON OBSERVED TINY MICROFIBERS SHEDDING FROM THE SUTURE MATERIAL. AS A PRECAUTIONARY MEASURE, THE HOSPITAL INITIATED AND DOCUMENTED A SAFETY INCIDENT IN ACCORDANCE WITH INTERNAL REPORTING PROTOCOLS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957560 ↗
• MalfunctionApr 22, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON OBSERVED TINY MICROFIBERS SHEDDING FROM THE SUTURE MATERIAL. AS A PRECAUTIONARY MEASURE, THE HOSPITAL INITIATED AND DOCUMENTED A SAFETY INCIDENT IN ACCORDANCE WITH INTERNAL REPORTING PROTOCOLS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957557 ↗
• MalfunctionApr 22, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON OBSERVED TINY MICROFIBERS SHEDDING FROM THE SUTURE MATERIAL. AS A PRECAUTIONARY MEASURE, THE HOSPITAL INITIATED AND DOCUMENTED A SAFETY INCIDENT IN ACCORDANCE WITH INTERNAL REPORTING PROTOCOLS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957555 ↗
• MalfunctionApr 22, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON OBSERVED TINY MICROFIBERS SHEDDING FROM THE SUTURE MATERIAL. AS A PRECAUTIONARY MEASURE, THE HOSPITAL INITIATED AND DOCUMENTED A SAFETY INCIDENT IN ACCORDANCE WITH INTERNAL REPORTING PROTOCOLS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957554 ↗
• MalfunctionApr 22, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON OBSERVED TINY MICROFIBERS SHEDDING FROM THE SUTURE MATERIAL. AS A PRECAUTIONARY MEASURE, THE HOSPITAL INITIATED AND DOCUMENTED A SAFETY INCIDENT IN ACCORDANCE WITH INTERNAL REPORTING PROTOCOLS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957550 ↗
• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A AORTOTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE DOCTOR HAD TO OPERATE ON A PATIENT AND WHEN HE REOPERATED ON THE SAME DAY THEY SAW THAT WHERE IT KNOTS THE SUTURE WAS CUT. THE SUTURE IS STILL IN THE PATIENT. HOWEVER, WE SEND THE REST OF THE SUTURES FROM THE SAME BOX AND BATCH FOR TESTING. PROCEDURE: IN AN AORTOTOMY AN AORTIC SUTURE MADE FOR SURGERY FOR A SUBAORTIC STENOSIS. THE SUTURE WAS CUT (NOT AT THE ENDS WHERE THE KNOTS ARE BUT IN THE MIDDLE OF THE SURGET). HE MENTIONS THAT THE NEEDLE HOLDER WAS NOT CHANGED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428477 ↗
• MalfunctionJan 7, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL AORTIC ANEURYSM PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT ABDOMINAL AORTIC ANEURYSM PROCEDURE, THE NEEDLE POPPED OFF FROM HE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN.. NO ADVERSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995987 ↗
• MalfunctionAug 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT, THE SUTURE BROKE. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS NOT FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922514 ↗
• MalfunctionApr 28, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIO THORACIC PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE SUTURES WERE EITHER BREAKING OR POPPING OFF THE NEEDLE. DOCTOR SAYS THE PRODUCTS ARE DEFECTIVE AND KEEPS BREAKING. HE REFUSES TO USE THE PRODUCT FROM THIS LOT NUMBER. THERE ARE 14 STERILE SAMPLES TO BE RETURNED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919820 ↗
• MalfunctionApr 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIO THORACIC PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE SUTURES WERE EITHER BREAKING OR POPPING OFF THE NEEDLE. DOCTOR SAYS THE PRODUCTS ARE DEFECTIVE AND KEEPS BREAKING. HE REFUSES TO USE THE PRODUCT FROM THIS LOT NUMBER. THERE ARE 14 STERILE SAMPLES TO BE RETURNED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919794 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIO THORACIC PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE SUTURES WERE EITHER BREAKING OR POPPING OFF THE NEEDLE. DOCTOR SAYS THE PRODUCTS ARE DEFECTIVE AND KEEPS BREAKING. HE REFUSES TO USE THE PRODUCT FROM THIS LOT NUMBER. THERE ARE 14 STERILE SAMPLES TO BE RETURNED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919775 ↗
• MalfunctionMar 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT SUTURE BROKE DURING VASCULAR CASE. SURGICAL DELAY UNKNOWN. NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732804 ↗
• MalfunctionMar 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT SUTURE BROKE DURING VASCULAR CASE. SURGICAL DELAY UNKNOWN. NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732803 ↗
• MalfunctionJul 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT WAS REPORTED THAT THE SURGEONS ARE USING QUITE A FEW OF THESE ON A DR. GAFFUD CASE AND A LOT OF THEM WERE BREAKING. 2 EACH(S) WILL BE SENT BACK FOR ANALYSIS. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298161 ↗
• MalfunctionJul 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT WAS REPORTED THAT THE SURGEONS ARE USING QUITE A FEW OF THESE ON A (B)(6) CASE AND A LOT OF THEM WERE BREAKING. 2 EACH(S) WILL BE SENT BACK FOR ANALYSIS. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298155 ↗
• MalfunctionJul 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT WAS REPORTED THAT THE SURGEONS ARE USING QUITE A FEW OF THESE ON A DR. GAFFUD CASE AND A LOT OF THEM WERE BREAKING. 2 EACH(S) WILL BE SENT BACK FOR ANALYSIS. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298152 ↗
• MalfunctionJul 20, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIAC SURGERY ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE BEFORE TYING THE KNOT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12195600 ↗
• MalfunctionJul 20, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIAC SURGERY ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE BEFORE TYING THE KNOT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12195597 ↗
• MalfunctionApr 16, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLES WERE POPPING OFF THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11681736 ↗
• MalfunctionApr 16, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLES WERE POPPING OFF THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11681728 ↗
• MalfunctionApr 16, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLES WERE POPPING OFF THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11681723 ↗

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-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• 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-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416

…and 6 more.