PROLENE D3986Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031024847), received between Feb 26, 2025 and Aug 13, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AORTIC VALVE REPAIR PROCEDURE, THE NEEDLE IMMEDIATELY POOPED OFF THE SUTURE AFTER SURGEON MADE HIS FIRST PATH. NO PATIENT CONSEQUENCES REPORTED. DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793397 ↗
• MalfunctionAug 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AORTIC VALVE REPAIR PROCEDURE, THE NEEDLE IMMEDIATELY POOPED OFF THE SUTURE AFTER SURGEON MADE HIS FIRST PATH. NO PATIENT CONSEQUENCES REPORTED. DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793396 ↗
• 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 22179737 ↗
• 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 22179731 ↗
• MalfunctionMay 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE, ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF MID ANASTOMOSIS. THE SURGERY WAS DISRUPTED AND THE SURGEONS WERE DISPLEASED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT HARM WAS REPORTED. THE DEVICE WAS DISCARDED ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079488 ↗
• MalfunctionFeb 26, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING MULTIPLE PROCEDURES WHEN THE DOUBLE ARMED SUTURE WAS OPENED IT APPEARED THAT THE NEEDLES WERE OF TWO DIFFERENT SIZES. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471320 ↗
• MalfunctionFeb 26, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING MULTIPLE PROCEDURES WHEN THE DOUBLE ARMED SUTURE WAS OPENED IT APPEARED THAT THE NEEDLES WERE OF TWO DIFFERENT SIZES. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471315 ↗
• MalfunctionFeb 26, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING MULTIPLE PROCEDURES WHEN THE DOUBLE ARMED SUTURE WAS OPENED IT APPEARED THAT THE NEEDLES WERE OF TWO DIFFERENT SIZES. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471300 ↗

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-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-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• 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-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189

…and 6 more.