PROLENE EPH8720HRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10705031233447), received between Mar 18, 2020 and Jan 21, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Material Separation” (21 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING CORONARY BUTTON ANASTOMOSIS IN A BENTALL PROCEDURE, THE SUTURE BROKE WHEN IT WAS PULLED AFTER PUTTING ABOUT THREE STITCHES. SUTURE BREAKAGE DURING SUTURING IS A COMMON OCCURRENCE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130382 ↗
• MalfunctionSep 24, 2025Material Separation; Material Separation

  IT WAS REPORTED TO THE SALES REP BY THE SURGEON THAT THE NEEDLE IS COMING OFF OF THE THREAD WITHOUT PRESSURE BEING APPLIED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE RETURNING. I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23137493 ↗
• MalfunctionSep 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KIDNEY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON THAT THE NEEDLE IS COMING OFF OF THE THREAD WITHOUT PRESSURE BEING APPLIED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23137490 ↗
• MalfunctionDec 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20921064 ↗
• MalfunctionDec 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20920561 ↗
• MalfunctionDec 3, 2024Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE POPPED OFF OF THE SUTURE WHILE DR. WAS SUTURING. THE SURGEON SAID THAT THEY FELT LIKE THE NEEDLE WAS BENDING MORE THAN USUAL. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833259 ↗
• MalfunctionMay 21, 2024Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURES FRAYED AND THE NEEDLE FELL OFF OF THE PROLENE SUTURES. THEY HAD TO GET A COMPLETE X-RAY INTREPIDLY TO FIND THE NEEDLE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359557 ↗
• MalfunctionMay 21, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURES FRAYED AND THE NEEDLE FELL OFF OF THE PROLENE SUTURES. THEY HAD TO GET A COMPLETE X-RAY INTREPIDLY TO FIND THE NEEDLE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359556 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN VALVE PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. THE NEEDLE DETACHED FROM THE 5/0 GAUGE PROLENE WIRE WITH EVER POINT HEMOSEAL TECHNOLOGY WHILE THEY WERE UNDERGOING THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841868 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN VALVE PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. THE NEEDLE DETACHED FROM THE 5/0 GAUGE PROLENE WIRE WITH EVERPOINT HEMOSEAL TECHNOLOGY WHILE THEY WERE UNDERGOING THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841179 ↗
• MalfunctionJan 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF THE SUTURE. THE THEATRE TEAM MANAGED TO FIND ONE OF THE SUTURES WHILE THE OTHER HAS BEEN LOST. THEY HAD TO X-RAY THE PATIENT BUT WERE NOT ABLE TO FIND IT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434662 ↗
• MalfunctionJan 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF THE SUTURE. THE THEATRE TEAM MANAGED TO FIND ONE OF THE SUTURES WHILE THE OTHER HAS BEEN LOST. THEY HAD TO X-RAY THE PATIENT BUT WERE NOT ABLE TO FIND IT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434661 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6). 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED. THE OTHER END OF THE NEEDLE GOT LOST, AND THE STAFF WAS LOOKING FOR THE MISSING NEEDLE FOR 20 MINUTES. THE STAFF WAS ABOUT TO CALL AN X-RAY TEAM TO X-RAY THE PATIENT, BUT THEN THE NEEDLE WAS FOUND ON THE FLOOR. THE PROCEDURE WAS PROLONGED DUE TO THE EVENT. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142642 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED. THE OTHER END OF THE NEEDLE GOT LOST, AND THE STAFF WAS LOOKING FOR THE MISSING NEEDLE FOR 20 MINUTES. THE STAFF WAS ABOUT TO CALL AN X-RAY TEAM TO X-RAY THE PATIENT, BUT THEN THE NEEDLE WAS FOUND ON THE FLOOR. THE PROCEDURE WAS PROLONGED DUE TO THE EVENT. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142640 ↗
• MalfunctionNov 2, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DISAPPEARED FROM THE END OF A DOUBLE ENDED 6/0 - WE NEEDED TO X-RAY AND EXCLUDED IT FROM THE WOUND BUT NEVER FOUND IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057212 ↗
• MalfunctionNov 2, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DISAPPEARED FROM THE END OF A DOUBLE ENDED 6/0 - WE NEEDED TO X-RAY AND EXCLUDED IT FROM THE WOUND BUT NEVER FOUND IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057182 ↗
• MalfunctionNov 2, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DISAPPEARED FROM THE END OF A DOUBLE ENDED 6/0 - WE NEEDED TO X-RAY AND EXCLUDED IT FROM THE WOUND BUT NEVER FOUND IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057165 ↗
• MalfunctionNov 2, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DISAPPEARED FROM THE END OF A DOUBLE ENDED 6/0 - WE NEEDED TO X-RAY AND EXCLUDED IT FROM THE WOUND BUT NEVER FOUND IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057143 ↗
• MalfunctionNov 1, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE WHILE BEING USED ON THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048897 ↗
• MalfunctionOct 19, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE OR CAME OUT OF THE SWAGE. THE NEEDLE DISAPPEARED FROM THE END OF THE 6/0 SUTURE. AN X-RAY WAS DONE AND EXCLUDED IT FROM THE WOUND, HOWEVER, THE NEEDLE WAS NEVER FOUND. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966933 ↗
• MalfunctionApr 10, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG WITH AVR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. DURING THE VALVE REPLACEMENT WHEN SECURING THE VALVE INTO THE AORTA THAT THE 3-0 SUTURE SNAPPED WHILE SECURING THE KNOT AND WHILE ATTACHING THE HARVESTED VEIN TO THE HEART THE 5-0 SUTURE SNAPPED WHILE TYING THE KNOT. A SECOND SUTURE WAS USED TO COMPLETE EACH PORTION OF THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709415 ↗
• MalfunctionAug 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN DOING ANASTOMOSIS TO THE AORTA, THE SUTURE BECAME DISCONNECTED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15197708 ↗
• MalfunctionMar 18, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE WHEN SEWING THE ANASTOMOSIS. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9848180 ↗
• MalfunctionMar 18, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE WHEN SEWING THE ANASTOMOSIS. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9848179 ↗
• MalfunctionMar 18, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE WHEN SEWING THE ANASTOMOSIS. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9848177 ↗

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-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• 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-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• 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

…and 6 more.