PROLENE HS6861HRecalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10705031232785), received between Dec 4, 2019 and Sep 14, 2026 — classified as 52 malfunctions.

The most frequently reported specific device problem is “Material Separation” (26 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Material Frayed

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753639 ↗
• MalfunctionSep 14, 2026Material Frayed

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. During aortic suturing, one suture detached from the needle. In addition, two other sutures from the same batch were found to be frayed. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753569 ↗
• MalfunctionSep 14, 2026Material Separation

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. During aortic suturing, one suture detached from the needle. In addition, two other sutures from the same batch were found to be frayed. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753415 ↗
• MalfunctionAug 17, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. During the surgery, when continuous suturing was performed, obvious burrs appeared on the suture from the first stitch, and knotting was prone to suture breakage. Total 3 products occurred suture burrs and suture breakage issue. Changed another one to complete the surgery. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50278018 ↗
• MalfunctionAug 17, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. During the surgery, when continuous suturing was performed, obvious burrs appeared on the suture from the first stitch, and knotting was prone to suture breakage. Total 3 products occurred suture burrs and suture breakage issue. Changed another one to complete the surgery. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50277911 ↗
• MalfunctionAug 17, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. During the surgery, when continuous suturing was performed, obvious burrs appeared on the suture from the first stitch, and knotting was prone to suture breakage. Total 3 products occurred suture burrs and suture breakage issue. Changed another one to complete the surgery. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50277843 ↗
• MalfunctionJul 1, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2026 AND SUTURE WAS USED. THE CUSTOMER REPORTS THAT DURING USE, THE NEEDLE HAS DETACHED FROM THE THREAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25680803 ↗
• MalfunctionJun 29, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN AORTIC VALVE REPAIR ON (B)(6) 2026 AND SUTURE WAS USED. THE NEEDLE HAS DETACHED FROM THE THREAD, THE SAME EPISODE HAD HAPPENED TO A COLLEAGUE OF HIS WHO HAD PREVIOUSLY BEEN TO HIM, OF WHOM WE HAD NOT BECOME AWARE. NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25658553 ↗
• MalfunctionJun 11, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHILE THE DOCTOR WAS SUTURING THE VALVE, THE SUTURE DETACHED FROM THE NEEDLE AT THE VERY FIRST STITCH. IT ALSO DETACHED WHEN REMOVING THE SUTURE FROM THE PACKAGE. THIS OCCURRED WITH APPROXIMATELY FOUR SUTURES, LEADING THE DOCTOR TO STOP USING THEM. (SAME LOT NUMBER). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25470656 ↗
• MalfunctionJun 11, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHILE THE DOCTOR WAS SUTURING THE VALVE, THE SUTURE DETACHED FROM THE NEEDLE AT THE VERY FIRST STITCH. IT ALSO DETACHED WHEN REMOVING THE SUTURE FROM THE PACKAGE. THIS OCCURRED WITH APPROXIMATELY FOUR SUTURES, LEADING THE DOCTOR TO STOP USING THEM. (SAME LOT NUMBER). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25470653 ↗
• MalfunctionJun 11, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHILE THE DOCTOR WAS SUTURING THE VALVE, THE SUTURE DETACHED FROM THE NEEDLE AT THE VERY FIRST STITCH. IT ALSO DETACHED WHEN REMOVING THE SUTURE FROM THE PACKAGE. THIS OCCURRED WITH APPROXIMATELY FOUR SUTURES, LEADING THE DOCTOR TO STOP USING THEM. (SAME LOT NUMBER). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25470636 ↗
• MalfunctionMay 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. A TOTAL 3 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25283775 ↗
• MalfunctionMay 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. A TOTAL 3 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25283452 ↗
• MalfunctionMay 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. A TOTAL 3 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25283442 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART FLUID REMOVAL SURGERY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN HEART FLUID REMOVAL SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SUTURE GOT SPLIT IN THE SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTO. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE NEEDLE DID NOT FELL INTO THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25201171 ↗
• MalfunctionMay 18, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART FLUID REMOVAL SURGERY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN HEART FLUID REMOVAL SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SUTURE GOT SPLIT IN THE SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTO. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE NEEDLE DID NOT FELL INTO THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25201165 ↗
• MalfunctionMay 18, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART FLUID REMOVAL SURGERY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN HEART FLUID REMOVAL SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SUTURE GOT SPLIT IN THE SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTO. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE NEEDLE DID NOT FELL INTO THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25201129 ↗
• MalfunctionJan 16, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING, IT WAS NOTICED THAT A PART OF THE SUTURE STARTED DE-LAYERING. THE SURGEON REMOVED THE SUTURE FROM TISSUE, AND FINISHED SUTURING WITH ANOTHER SUTURE. THERE WAS NO IMPACT ON THE PATIENT, THE OPERATION WAS PROLONGED FOR 2 MINUTES. THE PROCEDURE SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24097015 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DISCONNECTED. FURTHER CLARIFICATION WAS PROVIDED THAT THE SUTURE BROKE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22535484 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DISCONNECTED. FURTHER CLARIFICATION WAS PROVIDED THAT THE SUTURE BROKE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22535482 ↗
• MalfunctionJun 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE HEALTHCARE PROFESSIONAL USED HEMOSEAL AND IT BROKE AWAY FROM THE NEEDLE DURING OPERATING SO THEY HAVE THROWN AWAY THE ENTIRE BOX. APPARENTLY TWO OTHER CARDIAC SURGEONS THIS ALSO IS A COMMON OCCURRENCE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195869 ↗
• MalfunctionJun 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE HEALTHCARE PROFESSIONAL USED HEMOSEAL AND IT BROKE AWAY FROM THE NEEDLE DURING OPERATING SO THEY HAVE THROWN AWAY THE ENTIRE BOX. APPARENTLY TWO OTHER CARDIAC SURGEONS THIS ALSO IS A COMMON OCCURRENCE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195866 ↗
• MalfunctionJun 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE HEALTHCARE PROFESSIONAL USED HEMOSEAL AND IT BROKE AWAY FROM THE NEEDLE DURING OPERATING SO THEY HAVE THROWN AWAY THE ENTIRE BOX. APPARENTLY TWO OTHER CARDIAC SURGEONS THIS ALSO IS A COMMON OCCURRENCE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195862 ↗
• MalfunctionMay 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. AND THE DOCTOR REPORTED THAT THE OPENING AT THE END OF THE NEEDLE WAS RELATIVELY LARGE. 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 22096502 ↗
• MalfunctionDec 2, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, POSITION OF QR CODE IS NOT FIXED. IT'S REPORTED THAT THE POSITION OF QR CODE ON THE BACK OF STERILE PACKAGE OF PRODUCT IS NOT FIXED, WHICH AFFECTS THE SUBSEQUENT SCANNING BY CUSTOMER. MOST PRODUCTS' QR CODE IS FAR AWAY FROM CHEVRON END OF THE POUCH, BUT SOME CODE LIKE HS00681, ITS QR CODE IS CLOSE TO CHEVRON END OF THE POUCH. ENCLOSED PLEASE FIND ATTACHED EXAMPLE PHOTO. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20823507 ↗

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-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• 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-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881

…and 6 more.