PROLENE EP8755HRecalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 10705031206823), received between May 21, 2019 and Sep 17, 2026 — classified as 89 malfunctions.

The most frequently reported specific device problem is “Material Separation” (56 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 89 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810264 ↗
• MalfunctionSep 17, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810103 ↗
• MalfunctionSep 17, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810102 ↗
• MalfunctionMay 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COMPLEX CONGENITAL HEART SURGERY PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN COMPLEX CONGENITAL HEART SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25229113 ↗
• MalfunctionApr 6, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN SUTURING VENTRICULAR SEPTAL DEFECT . 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 24793252 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, A RUPTURE WAS ENCOUNTERED WHILE TYING A KNOT AT THE END OF ANASTOMOSIS IN THE PRODUCT WITH REF CODE EP8755. THE PRODUCT WANTS TO BE INVESTIGATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821320 ↗
• MalfunctionSep 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPERINEAL RESECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THIS MORNING, I WAS CONTACTED BY THE DOCTOR REGARDING THE PROLENE THREAD THAT WAS USED AND HAS BROKEN AGAIN. AFTER CHECKING, IT WAS FOUND THAT THE LOT NUMBER IS THE SAME AS THE PREVIOUS ONE. THE DOCTOR REQUESTED AN INVESTIGATION AND TO REPLACE THE ITEM WITH A NEW ONE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076293 ↗
• MalfunctionSep 11, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A VISION SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING SUTURING, THE SUTURE BROKE IN THE MIDDLE. THEN DR REPLACED IT WITH A NEW SUTURE OF THE SAME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027685 ↗
• MalfunctionSep 11, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A VISION SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING SUTURING, THE SUTURE BROKE IN THE MIDDLE. THEN DR REPLACED IT WITH A NEW SUTURE OF THE SAME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027473 ↗
• MalfunctionSep 11, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A VISION SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING SUTURING, THE SUTURE BROKE IN THE MIDDLE. THEN DR REPLACED IT WITH A NEW SUTURE OF THE SAME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027446 ↗
• MalfunctionJun 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IN SOME PACKAGINGS, THE NEEDLE WAS PARTIALLY ASSEMBLED WITH SUTURES AND WHEN THE SURGEON TRY TO PASS THE NEEDLE TO THE VESSEL, IT CAME OF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127747 ↗
• MalfunctionJun 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IN SOME PACKAGINGS, THE NEEDLE WAS PARTIALLY ASSEMBLED WITH SUTURES AND WHEN THE SURGEON TRY TO PASS THE NEEDLE TO THE VESSEL, IT CAME OF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127744 ↗
• MalfunctionMar 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN VASCULAR PROCEDURE THAT THE SURGEON STATED HE HAS BEEN HAVING A RECURRING ISSUE WITH THE SUTURE BREAKING DURING SURGERY. NO FURTHER INFORMATION WAS PROVIDED TO THE SALES REP. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ONE STERILE SAMPLE FROM EACH LOT RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21537979 ↗
• MalfunctionMar 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN VASCULAR PROCEDURE THAT THE SURGEON STATED HE HAS BEEN HAVING A RECURRING ISSUE WITH THE SUTURE BREAKING DURING SURGERY. NO FURTHER INFORMATION WAS PROVIDED TO THE SALES REP. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ONE STERILE SAMPLE FROM EACH LOT RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21537972 ↗
• MalfunctionFeb 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A CABG, THE NEEDLE WAS BREAKING OFF OF THE SUTURE STRAND. THIS OCCURRED WITH THREE DIFFERENT SUTURES. CASE COMPLETED WITH A NEW BOX. NO PATIENT HARM WAS REPORTED. STERILE SAMPLES WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21451144 ↗
• MalfunctionFeb 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A CABG, THE NEEDLE WAS BREAKING OFF OF THE SUTURE STRAND. THIS OCCURRED WITH THREE DIFFERENT SUTURES. CASE COMPLETED WITH A NEW BOX. NO PATIENT HARM WAS REPORTED. STERILE SAMPLES WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21451094 ↗
• MalfunctionFeb 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A CABG, THE NEEDLE WAS BREAKING OFF OF THE SUTURE STRAND. THIS OCCURRED WITH THREE DIFFERENT SUTURES. CASE COMPLETED WITH A NEW BOX. NO PATIENT HARM WAS REPORTED. STERILE SAMPLES WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21451082 ↗
• MalfunctionJan 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY THE SALES CONSULTANT THAT IN A SURGERY ON THE 11TH THE PRODUCT SUTURE FOR A CARDIAC PROCEDURE WHEN HE WENT TO TIE THE SUTURE IT BROKE. HE TIRED THE SECOND TIME, AND IT BROKE AS WELL. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148839 ↗
• MalfunctionJan 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY THE SALES CONSULTANT THAT IN A SURGERY ON THE (B)(6) THE PRODUCT SUTURE FOR A CARDIAC PROCEDURE WHEN HE WENT TO TIE THE SUTURE IT BROKE. HE TIRED THE SECOND TIME, AND IT BROKE AS WELL. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148838 ↗
• MalfunctionOct 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20428707 ↗
• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE DURING USE. CHANGED TO 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 20273505 ↗
• MalfunctionSep 16, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEON PERFORMED CABG AND TWO SUTURES HAD ISSUE WITH NEEDLE BREAKAGE, AND FEW HAD DETACHMENT OF NEEDLE AND THREAD. THEY OPENED ANOTHER BOX OF SAME CODE AND CONTINUED THE PROCEDURE. PROCEDURE WAS PERFORMED SUCCESSFULLY TILL THE END, NO CONSEQUENCES FOR PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20231901 ↗
• MalfunctionSep 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEON PERFORMED CABG AND TWO SUTURES HAD ISSUE WITH NEEDLE BREAKAGE, AND FEW HAD DETACHMENT OF NEEDLE AND THREAD. THEY OPENED ANOTHER BOX OF SAME CODE AND CONTINUED THE PROCEDURE. PROCEDURE WAS PERFORMED SUCCESSFULLY TILL THE END, NO CONSEQUENCES FOR PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20194731 ↗
• MalfunctionSep 11, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEON PERFORMED CABG AND TWO SUTURES HAD ISSUE WITH NEEDLE BREAKAGE, AND FEW HAD DETACHMENT OF NEEDLE AND THREAD. THEY OPENED ANOTHER BOX OF SAME CODE AND CONTINUED THE PROCEDURE. PROCEDURE WAS PERFORMED SUCCESSFULLY TILL THE END, NO CONSEQUENCES FOR PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20194142 ↗
• MalfunctionSep 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEON PERFORMED CABG AND TWO SUTURES HAD ISSUE WITH NEEDLE BREAKAGE, AND FEW HAD DETACHMENT OF NEEDLE AND THREAD. THEY OPENED ANOTHER BOX OF SAME CODE AND CONTINUED THE PROCEDURE. PROCEDURE WAS PERFORMED SUCCESSFULLY TILL THE END, NO CONSEQUENCES FOR PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20193279 ↗

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-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• 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-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768

…and 6 more.