PROLENE 8710HRecalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10705031019546), received between Jun 11, 2018 and May 27, 2026 — classified as 3 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Break” (52 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 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE IS WEAK AND BREAKS; SUTURE CUTS OFF AFTER PASSING THROUGH TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299719 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE IS WEAK AND BREAKS; SUTURE CUTS OFF AFTER PASSING THROUGH TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299715 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE IS WEAK AND BREAKS; SUTURE CUTS OFF AFTER PASSING THROUGH TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299709 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE IS WEAK AND BREAKS; SUTURE CUTS OFF AFTER PASSING THROUGH TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299708 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE IS WEAK AND BREAKS; SUTURE CUTS OFF AFTER PASSING THROUGH TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299620 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE IS WEAK AND BREAKS; SUTURE CUTS OFF AFTER PASSING THROUGH TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299617 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE IS WEAK AND BREAKS; SUTURE CUTS OFF AFTER PASSING THROUGH TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299615 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE IS WEAK AND BREAKS; SUTURE CUTS OFF AFTER PASSING THROUGH TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299613 ↗
• MalfunctionMay 21, 2026Break; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE IS WEAK AND BREAKS; SUTURE CUTS OFF AFTER PASSING THROUGH TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240293 ↗
• MalfunctionMay 21, 2026Break; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DTAE AND SUTURE WAS USED. NEEDLE IS WEAK AND BREAKS; SUTURE CUTS OFF AFTER PASSING THROUGH TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240292 ↗
• MalfunctionMay 21, 2026Break; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE IS WEAK AND BREAKS; SUTURE CUTS OFF AFTER PASSING THROUGH TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240291 ↗
• MalfunctionMay 21, 2026Break; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DTAE AND SUTURE WAS USED. NEEDLE IS WEAK AND BREAKS; SUTURE CUTS OFF AFTER PASSING THROUGH TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240290 ↗
• MalfunctionMay 21, 2026Break; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DTAE AND SUTURE WAS USED. NEEDLE IS WEAK AND BREAKS; SUTURE CUTS OFF AFTER PASSING THROUGH TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240286 ↗
• MalfunctionMay 21, 2026Break; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE IS WEAK AND BREAKS; SUTURE CUTS OFF AFTER PASSING THROUGH TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240285 ↗
• MalfunctionMay 21, 2026Break; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE IS WEAK AND BREAKS; SUTURE CUTS OFF AFTER PASSING THROUGH TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240284 ↗
• MalfunctionMay 21, 2026Break; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DTAE AND SUTURE WAS USED. NEEDLE IS WEAK AND BREAKS; SUTURE CUTS OFF AFTER PASSING THROUGH TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240199 ↗
• MalfunctionMay 14, 2026Break; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE IS WEAK AND BREAKS; SUTURE CUTS OFF AFTER PASSING THROUGH TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171827 ↗
• MalfunctionMay 14, 2026Break; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DTAE AND SUTURE WAS USED. NEEDLE IS WEAK AND BREAKS; SUTURE CUTS OFF AFTER PASSING THROUGH TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171611 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LIVER TRANSPLANT UNDER GENERAL ANESTHESIA PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT UNDERWENT SURGERY AT 14:25 DUE TO THE NEED FOR MEDICAL CONDITIONS. DURING THE SURGERY, SUTURES WERE USED TO SUTURE THE BLOOD VESSELS. THE OPERATOR USED UNOPENED SUTURE WITHOUT ANY VISIBLE ABNORMALITIES, WITHIN THE VALIDITY PERIOD, AND OPERATED ACCORDING TO THE SUTURE USER MANUAL. AT AROUND 17:33, THE INSTRUMENT NURSE CLAMPED THE SUTURE AND HANDED IT OVER TO THE SURGEON FOR SUTURING THE PATIENT'S BLEEDING VESSEL. WHEN THE SURGEON WAS PREPARING TO TIE THE KNOT AFTER SUTURING, THE SUTURE BROKE, CAUSING THE BLOOD VESSEL THAT SHOULD BE SUTURED DURING THE OPERATION TO BE UNABLE TO CLOSE, RESULTING IN AN INCREASE IN THE PATIENT'S INTRAOPERATIVE BLEEDING VOLUME. THE SURGEON IMMEDIATELY TOOK EMERGENCY MEASURES TO STOP BLEEDING AND CLEAN UP THE BROKEN SUTURE AFTER DISCOVERING THE PATIENT'S BLEEDING. THE INSTRUMENT NURSE SYNCHRONOUSLY REPLACED THE SUTURE WITH A NEW ONE AND RE SUTURED IT. AFTER REPLACING THE SUTURE WITH A NEW ONE TO COMPLETE THE VASCULAR CLOSURE, THE SURGERY CONTINUED AND THE PATIENT'S CONDITION STABILIZED POSTOPERATIVELY. NO ADVERSE PA

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23843182 ↗
• MalfunctionJun 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN NUMBER OF CARDIOVASCULAR PROCEDURE ACROSS MULTIPLE SURGEONS, THE NEEDLE POPPED OFF MID ANASTOMOSIS ON A CORONARY BUTTON. SURGERY WAS DEFINITELY DISRUPTED AND THE SURGEONS WERE DISPLEASED. CASES WERE COMPLETED SUCCESSFULLY. NO 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 22179736 ↗
• MalfunctionJun 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN NUMBER OF CARDIOVASCULAR PROCEDURE ACROSS MULTIPLE SURGEONS, THE NEEDLE POPPED OFF MID ANASTOMOSIS ON A CORONARY BUTTON. SURGERY WAS DEFINITELY DISRUPTED AND THE SURGEONS WERE DISPLEASED. CASES WERE COMPLETED SUCCESSFULLY. NO 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 22179729 ↗
• MalfunctionJun 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE NEEDLE POPPED OFF MID ANASTOMOSIS ON A CORONARY BUTTON. SURGERY WAS DEFINITELY DISRUPTED, AND THE SURGEONS WERE DISPLEASED. CASE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170425 ↗
• MalfunctionMar 3, 2025Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT ABDOMINAL CLOSURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE BROKE FROM THE THREAD WHILE THE DOCTOR IS SUTURING THE PATIENT DURING THE PROCEDURE. SURGERY WAS DELAYED, 3 MINUTES. ANOTHER SUTURE WAS OPEN ANOTHER BOX OR BATCH OF NEW SUTURE, PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21509814 ↗
• MalfunctionMar 3, 2025Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT ABDOMINAL CLOSURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE BROKE FROM THE THREAD WHILE THE DOCTOR IS SUTURING THE PATIENT DURING THE PROCEDURE. SURGERY WAS DELAYED, 3 MINUTES. ANOTHER SUTURE WAS OPEN ANOTHER BOX OR BATCH OF NEW SUTURE, PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21509810 ↗
• MalfunctionSep 24, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292904 ↗

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-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• 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-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• 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-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-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881

…and 6 more.