PROLENE 8610HRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10705031017719), received between Oct 15, 2019 and Mar 18, 2026 — classified as 2 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (22 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.

• MalfunctionMar 18, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WRITTEN ON THE BOX (DO NOT USE FOR CAROTID ONLY FOR FISTULA'S) REASON BEING SUTURE BREAKS EASILY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631245 ↗
• MalfunctionMar 16, 2026Break; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WRITTEN ON THE BOX (DO NOT USE FOR CAROTID ONLY FOR FISTULA'S) REASON BEING SUTURE BREAKS EASILY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24610026 ↗
• MalfunctionMar 16, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WRITTEN ON THE BOX (DO NOT USE FOR CAROTID ONLY FOR FISTULA'S) REASON BEING SUTURE BREAKS EASILY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24609974 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE DETACHED FROM NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838570 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE DETACHED FROM NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838566 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE DETACHED FROM NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838565 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE DETACHED FROM NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838564 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE DETACHED FROM NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838558 ↗
• MalfunctionMar 31, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. PRE-OP, FOUND A FOREIGN OBJECT IN THE PRODUCT PACKAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732355 ↗
• InjuryJan 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE FOR A INGUINAL TUBULAR PROSTHESIS ON AN UNKNOWN DATE AND SUTURE WAS USED TO SUTURE. POST-OP, THE PATIENT EXPERIENCED BLEEDING. THE PATIENT UNDERWENT REVISION FOR THE INGUINAL TUBULAR PROSTHESIS DUE TO THE BLEEDING. DURING THE REVISION, IT WAS FOUND THAT THE SUTURE FILAMENT HAD BROKEN LONGITUDINALLY AND BROKE INTO SEVERAL INDIVIDUAL FILAMENTS. THE SAME TYPE OF SUTURE WAS USED FOR THE REVISION SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21102019 ↗
• InjuryJan 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE FOR A INGUINAL TUBULAR PROSTHESIS ON AN UNKNOWN DATE AND SUTURE WAS USED TO SUTURE. POST-OP, THE PATIENT EXPERIENCED BLEEDING. THE PATIENT UNDERWENT REVISION FOR THE INGUINAL TUBULAR PROSTHESIS DUE TO THE BLEEDING. DURING THE REVISION, IT WAS FOUND THAT THE SUTURE FILAMENT HAD BROKEN LONGITUDINALLY AND BROKE INTO SEVERAL INDIVIDUAL FILAMENTS. THE SAME TYPE OF SUTURE WAS USED FOR THE REVISION SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21102018 ↗
• MalfunctionSep 20, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE CONTAINED COTTON HAIRLINE PROPERTIES. SURGEON SAID ITS LIKE THE SUTURE HAD 2 LAYERS AND THE FIRST LAYER CAME OFF AND WAS ALMOST LEFT WITH A HAIR LIKE STRAND. SUTURE BECAME COTTON LIKE, ALMOST LIKE A HAIR. DESCRIBED IT AS THE THREAD WAS COMING OFF THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268949 ↗
• MalfunctionNov 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE KEPT POPPING OFF AND SUTURES KEPT BREAKING DURING A CABG PROCEDURE. EIGHT OF THEM RESULTED WITH THIS ISSUE IN THE SAME CASE AND A SIMILAR LIKE DEVICE WAS USED TO COMPLETE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155447 ↗
• MalfunctionNov 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE KEPT POPPING OFF AND SUTURES KEPT BREAKING DURING A CABG PROCEDURE. EIGHT OF THEM RESULTED WITH THIS ISSUE IN THE SAME CASE AND A SIMILAR LIKE DEVICE WAS USED TO COMPLETE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155439 ↗
• MalfunctionNov 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE KEPT POPPING OFF AND SUTURES KEPT BREAKING DURING A CABG PROCEDURE. EIGHT OF THEM RESULTED WITH THIS ISSUE IN THE SAME CASE AND A SIMILAR LIKE DEVICE WAS USED TO COMPLETE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155434 ↗
• MalfunctionNov 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE KEPT POPPING OFF AND SUTURES KEPT BREAKING DURING A CABG PROCEDURE. EIGHT OF THEM RESULTED WITH THIS ISSUE IN THE SAME CASE AND A SIMILAR LIKE DEVICE WAS USED TO COMPLETE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155432 ↗
• MalfunctionNov 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE KEPT POPPING OFF AND SUTURES KEPT BREAKING DURING A CABG PROCEDURE. EIGHT OF THEM RESULTED WITH THIS ISSUE IN THE SAME CASE AND A SIMILAR LIKE DEVICE WAS USED TO COMPLETE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155431 ↗
• MalfunctionNov 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE KEPT POPPING OFF AND SUTURES KEPT BREAKING DURING A CABG PROCEDURE. EIGHT OF THEM RESULTED WITH THIS ISSUE IN THE SAME CASE AND A SIMILAR LIKE DEVICE WAS USED TO COMPLETE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155413 ↗
• MalfunctionNov 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE KEPT POPPING OFF AND SUTURES KEPT BREAKING DURING A CABG PROCEDURE. EIGHT OF THEM RESULTED WITH THIS ISSUE IN THE SAME CASE AND A SIMILAR LIKE DEVICE WAS USED TO COMPLETE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155412 ↗
• MalfunctionNov 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE KEPT POPPING OFF AND SUTURES KEPT BREAKING DURING A CABG PROCEDURE. EIGHT OF THEM RESULTED WITH THIS ISSUE IN THE SAME CASE AND A SIMILAR LIKE DEVICE WAS USED TO COMPLETE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155410 ↗
• MalfunctionApr 5, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED TO PERFORM ANASTOMOSIS OF BLOOD VESSELS. DURING THE SUTURING, THE SURGEON NOTICED THAT THE SUTURE WAS FALLING APART, HE ASKED TO USE ANOTHER SUTURE BUT THE ADDITIONAL SUTURE THEY OPENED FOR HIM ALSO FELL APART DURING THE SUTURING. THIS HAPPENED WITH 3 IDENTICAL SUTURES FROM THE SAME PACKAGE. FINALLY, THEY USED ONE THAT DID NOT FALL APART AND SUCCESSFULLY COMPLETED THE OPERATION. NO HARM WAS CAUSED TO THE PATIENT AND THERE WAS NO SIGNIFICANT DELAY IN THE OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16684070 ↗
• MalfunctionApr 5, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED TO PERFORM ANASTOMOSIS OF BLOOD VESSELS. DURING THE SUTURING, THE SURGEON NOTICED THAT THE SUTURE WAS FALLING APART, HE ASKED TO USE ANOTHER SUTURE BUT THE ADDITIONAL SUTURE THEY OPENED FOR HIM ALSO FELL APART DURING THE SUTURING. THIS HAPPENED WITH 3 IDENTICAL SUTURES FROM THE SAME PACKAGE. FINALLY, THEY USED ONE THAT DID NOT FALL APART AND SUCCESSFULLY COMPLETED THE OPERATION. NO HARM WAS CAUSED TO THE PATIENT AND THERE WAS NO SIGNIFICANT DELAY IN THE OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16683962 ↗
• MalfunctionApr 5, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED TO PERFORM ANASTOMOSIS OF BLOOD VESSELS. DURING THE SUTURING, THE SURGEON NOTICED THAT THE SUTURE WAS FALLING APART, HE ASKED TO USE ANOTHER SUTURE BUT THE ADDITIONAL SUTURE THEY OPENED FOR HIM ALSO FELL APART DURING THE SUTURING. THIS HAPPENED WITH 3 IDENTICAL SUTURES FROM THE SAME PACKAGE. FINALLY, THEY USED ONE THAT DID NOT FALL APART AND SUCCESSFULLY COMPLETED THE OPERATION. NO HARM WAS CAUSED TO THE PATIENT AND THERE WAS NO SIGNIFICANT DELAY IN THE OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16683961 ↗
• MalfunctionMar 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AV FISTULA PROCEDURE (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, FOUR SUTURES HAD THE NEEDLE POP OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16580008 ↗
• MalfunctionMar 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AV FISTULA PROCEDURE 02/22/2023 AND SUTURE WAS USED. DURING THE PROCEDURE, FOUR SUTURES HAD THE NEEDLE POP OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16580005 ↗

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-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
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• 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-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• 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-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879

…and 6 more.