PROLENE EP8709HRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10705031208308), received between Apr 10, 2019 and Jun 4, 2026 — classified as 1 injury, 33 malfunctions.

The most frequently reported specific device problem is “Break” (25 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.

• MalfunctionJun 4, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, FEW OF THAT SUTURES HAD ISSUE WITH NEEDLE GETTING DISCONNECTED OF THE THREAD WITH MINIMAL STRENGTH USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25393322 ↗
• MalfunctionJun 4, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, FEW OF THAT SUTURES HAD ISSUE WITH NEEDLE GETTING DISCONNECTED OF THE THREAD WITH MINIMAL STRENGTH USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25393319 ↗
• MalfunctionSep 17, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT IS CLEARLY A MANUFACTURING DEFECT. UPON OPENING THE FOIL, IT BECOMES EVIDENT THAT ONE OF THE TWO NEEDLES HAS BEEN INADVERTENTLY SEALED INSIDE THE PACKAGING. DID THE EVENT OCCUR DURING STERILE PROCESSING? YES, DID THE EVENT OCCUR DURING FIELD INSPECTION? YES, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO PATIENT INVOLVEMENT, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076032 ↗
• MalfunctionApr 25, 2025Break; Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911474 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE SUTURE BREAKS WHEN USED. IT IS NOT WHERE THE NEEDLE IS ATTACHED, BUT APPROX. 5-7 CM FROM THE ATTACHMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641246 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE SUTURE BREAKS WHEN USED. IT IS NOT WHERE THE NEEDLE IS ATTACHED, BUT APPROX. 5-7 CM FROM THE ATTACHMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641240 ↗
• MalfunctionFeb 20, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. VASCULAR SURGEONS ARE SAYING IS SNAPPING AND FAULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424236 ↗
• MalfunctionFeb 20, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. VASCULAR SURGEONS ARE SAYING IS SNAPPING AND FAULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424000 ↗
• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ARTERY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE RIGHT AT THE SWAGE. ANOTHER LIKE DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21316041 ↗
• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ARTERY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE RIGHT AT THE SWAGE. ANOTHER LIKE DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21316040 ↗
• MalfunctionFeb 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ARTERY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE RIGHT AT THE SWAGE. ANOTHER LIKE DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21300117 ↗
• MalfunctionFeb 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ARTERY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE RIGHT AT THE SWAGE. ANOTHER LIKE DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21300110 ↗
• MalfunctionFeb 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ARTERY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE RIGHT AT THE SWAGE. ANOTHER LIKE DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21300051 ↗
• MalfunctionFeb 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ARTERY PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE RIGHT AT THE SWAGE. ANOTHER LIKE DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21300046 ↗
• MalfunctionFeb 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ARTERY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE RIGHT AT THE SWAGE. ANOTHER LIKE DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21300023 ↗
• MalfunctionFeb 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ARTERY PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE RIGHT AT THE SWAGE. ANOTHER LIKE DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21300015 ↗
• MalfunctionFeb 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ARTERY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE IN THE MIDDLE WHILE TYING. ANOTHER LIKE DEVICE FROM THE SAME LOT WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21299981 ↗
• MalfunctionFeb 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ARTERY PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE IN THE MIDDLE WHILE TYING. ANOTHER LIKE DEVICE FROM THE SAME LOT WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21299979 ↗
• MalfunctionFeb 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ARTERY PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE RIGHT AT THE SWAGE. ANOTHER LIKE DEVICE FROM THE SAME LOT WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21299977 ↗
• MalfunctionFeb 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ARTERY PROCEDURE ON(B)(6)2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE RIGHT AT THE SWAGE. ANOTHER LIKE DEVICE FROM THE SAME LOT WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21299975 ↗
• MalfunctionNov 20, 2024Material Separation; Defective Component; Material Separation; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES ARE DRY, AND THE NEEDLES ARE POPPING OFF. THEY SPENT 15 MINUTES SEARCHING THE FLOOR IN THE ROOM FOR ONE OF THE SUTURES THAT POPPED OFF TODAY. DR ASKED WHAT IS GOING TO BE DONE ABOUT THESE SUTURES, IT'S HAPPENING DAILY WITH MANY DIFFERENT LOT NUMBERS AND NOW EVEN 2 DIFFERENT NEEDLES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20738007 ↗
• MalfunctionNov 20, 2024Material Separation; Defective Component; Material Separation; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES ARE DRY, AND THE NEEDLES ARE POPPING OFF. THEY SPENT 15 MINUTES SEARCHING THE FLOOR IN THE ROOM FOR ONE OF THE SUTURES THAT POPPED OFF TODAY. DR ASKED WHAT IS GOING TO BE DONE ABOUT THESE SUTURES, IT'S HAPPENING DAILY WITH MANY DIFFERENT LOT NUMBERS AND NOW EVEN 2 DIFFERENT NEEDLES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736244 ↗
• MalfunctionJul 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KIDNEY SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF THE POLYMER. ALMOST AS IF THIS WAS A CONTROLLED RELEASE SUTURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761063 ↗
• MalfunctionJul 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KIDNEY SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF THE POLYMER. ALMOST AS IF THIS WAS A CONTROLLED RELEASE SUTURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761061 ↗
• InjuryApr 30, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE SUTURE BROKE. THIS RESULTED IN A REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hematoma; Insufficient Information; Speech Disorder

  MAUDE report 19215625 ↗

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-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• 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-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• 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-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• 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-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-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746

…and 6 more.