PROLENE 8411HRecalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10705031015234), received between May 13, 2019 and Aug 31, 2026 — classified as 50 malfunctions.

The most frequently reported specific device problem is “Material Separation” (31 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50531349 ↗
• MalfunctionMar 4, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP THAT THE GENERAL SURGERY TEAM WAS USING SUTURE ON A NEEDLE AND THE SUTURE WAS POPPING OFF THE NEEDLE. ONE DEVICE RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507454 ↗
• MalfunctionJan 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE COMES LOOSE FROM THE SWAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24074753 ↗
• MalfunctionJan 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE COMES LOOSE FROM THE SWAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24074716 ↗
• MalfunctionJan 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE COMES LOOSE FROM THE SWAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24074666 ↗
• MalfunctionJan 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE COMES LOOSE FROM THE SWAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24074489 ↗
• MalfunctionJan 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE COMES LOOSE FROM THE SWAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24074397 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE NEEDLE KEEPS ON COMING OFF THE SUTURE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839252 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE NEEDLE KEEPS ON COMING OFF THE SUTURE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839239 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE NEEDLE KEEPS ON COMING OFF THE SUTURE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839219 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE NEEDLE KEEPS ON COMING OFF THE SUTURE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839203 ↗
• MalfunctionDec 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. SUTURE CAME OFF NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706715 ↗
• MalfunctionJul 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHILE SUTURING, THE THREAD COMES LOOSE FROM THE NEEDLE ATTACHMENT. THIS HAPPENS WITH SEVERAL SIMILAR SUTURES. AT THE END YOU HAVE TO CHANGE THE SUTURE TO ANOTHER ONE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22512885 ↗
• MalfunctionJul 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHILE SUTURING, THE THREAD COMES LOOSE FROM THE NEEDLE ATTACHMENT. THIS HAPPENS WITH SEVERAL SIMILAR SUTURES. AT THE END YOU HAVE TO CHANGE THE SUTURE TO ANOTHER ONE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22512840 ↗
• MalfunctionMay 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE OR HAS HAD A FEW COMPLAINTS ABOUT THE SUTURE BREAKING OFF FROM THE NEEDLE WITH SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088334 ↗
• MalfunctionMay 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE OR HAS HAD A FEW COMPLAINTS ABOUT THE SUTURE BREAKING OFF FROM THE NEEDLE WITH SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088333 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE NINE SUTURES BROKE WHILE SUTURING UNKNOWN TISSUE. A NEW BOX OF A DIFFERENT LOT WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. 18 STERILE SAMPLES RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967547 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE NINE SUTURES BROKE WHILE SUTURING UNKNOWN TISSUE. A NEW BOX OF A DIFFERENT LOT WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. 18 STERILE SAMPLES RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967466 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE NINE SUTURES BROKE WHILE SUTURING UNKNOWN TISSUE. A NEW BOX OF A DIFFERENT LOT WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. 18 STERILE SAMPLES RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967462 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE NINE SUTURES BROKE WHILE SUTURING UNKNOWN TISSUE. A NEW BOX OF A DIFFERENT LOT WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. 18 STERILE SAMPLES RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967409 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE NINE SUTURES BROKE WHILE SUTURING UNKNOWN TISSUE. A NEW BOX OF A DIFFERENT LOT WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. 18 STERILE SAMPLES RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967343 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE NINE SUTURES BROKE WHILE SUTURING UNKNOWN TISSUE. A NEW BOX OF A DIFFERENT LOT WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. 18 STERILE SAMPLES RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967327 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE NINE SUTURES BROKE WHILE SUTURING UNKNOWN TISSUE. A NEW BOX OF A DIFFERENT LOT WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. 18 STERILE SAMPLES RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967318 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE NINE SUTURES BROKE WHILE SUTURING UNKNOWN TISSUE. A NEW BOX OF A DIFFERENT LOT WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. 18 STERILE SAMPLES RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967309 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE NINE SUTURES BROKE WHILE SUTURING UNKNOWN TISSUE. A NEW BOX OF A DIFFERENT LOT WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. 18 STERILE SAMPLES RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967299 ↗

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-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• 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-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• 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

…and 6 more.