PROLENE 8741HRecalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10705031000049), received between May 15, 2019 and Sep 22, 2026 — classified as 49 malfunctions.

The most frequently reported specific device problem is “Material Separation” (27 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859341 ↗
• MalfunctionSep 21, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6)2026 and suture was used. It was reported by the Sales Rep, that suture continues to break despite fine previous use. They pulled lot and provided product. The device was returning. There were no patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842673 ↗
• MalfunctionSep 8, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. During the procedure, the suture broke. There were no adverse patient consequences. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670210 ↗
• MalfunctionJun 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SURGICAL PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE MATERIAL WHILE SUTURING. THE NEEDLE-SUTURE SEPARATION OCCURRED DURING NORMAL USE. THERE WAS A SURGICAL DELAY REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25536250 ↗
• MalfunctionMay 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, DOCTOR WAS DOING CABG PROCEDURE, WHEN HE WAS DOING DISTAL ANASTOMOSIS WITH THE HELP OF PROLENE 8732H & 8741H THEN SUTURE GOT BREAKDOWN FROM THE MID POINT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25229326 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT THERE WAS NO CHANGE IN TECHNIQUE OR PROCEDURE THE SUTURE BROKE EASILY. 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 24379069 ↗
• MalfunctionJul 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING CARDIAC VASCULAR SURGERY, NEEDLE DETACHES EASILY FROM THE SUTURE AND THE SUTURES ARE TANGLED. NO ADVERSE IMPACT TO PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371037 ↗
• MalfunctionJan 9, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFTING PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED ON THE VASCULAR ANASTOMOSIS, DURING CONTINUOUS SUTURING, THE SUTURE WAS BROKEN DURING USE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21111252 ↗
• MalfunctionAug 15, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING A CORONARY ARTERY BYPASS GRAFTING: CABG, DURING CONTINUOUS SUTURING, AND DURING LIGATION OF THE PERIPHERAL ANASTOMOSIS, IT HAD OCCURRED CONTINUOUSLY THE SUTURE BREAKAGE AT A POINT THAT WAS NOT THE LIGATURE POINT. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991266 ↗
• MalfunctionAug 15, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING A CORONARY ARTERY BYPASS GRAFTING: CABG, DURING CONTINUOUS SUTURING, AND DURING LIGATION OF THE PERIPHERAL ANASTOMOSIS, IT HAD OCCURRED CONTINUOUSLY THE SUTURE BREAKAGE AT A POINT THAT WAS NOT THE LIGATURE POINT. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991265 ↗
• MalfunctionAug 15, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING A CORONARY ARTERY BYPASS GRAFTING: CABG, DURING CONTINUOUS SUTURING, AND DURING LIGATION OF THE PERIPHERAL ANASTOMOSIS, IT HAD OCCURRED CONTINUOUSLY THE SUTURE BREAKAGE AT A POINT THAT WAS NOT THE LIGATURE POINT. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991241 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CABG (CORONARY ARTERY BYPASS GRAFT) PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. DURING THE SURGERY, THE SURGEON EXPERIENCED SUTURES THAT WERE TEARING OFF. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18970772 ↗
• MalfunctionDec 19, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE NEEDLE IS COMING UNATTACHED FROM THE SUTURE. THE EXACT PASS OF THE SUTURE IS UNKNOWN WHEN THE SUTURE IS COMING APART FROM THE NEEDLE. CASE COMPLETED WITH LIKE DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356108 ↗
• MalfunctionDec 19, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE NEEDLE IS COMING UNATTACHED FROM THE SUTURE. THE EXACT PASS OF THE SUTURE IS UNKNOWN WHEN THE SUTURE IS COMING APART FROM THE NEEDLE. CASE COMPLETED WITH LIKE DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356103 ↗
• MalfunctionDec 19, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE NEEDLE IS COMING UNATTACHED FROM THE SUTURE. THE EXACT PASS OF THE SUTURE IS UNKNOWN WHEN THE SUTURE IS COMING APART FROM THE NEEDLE. CASE COMPLETED WITH LIKE DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356099 ↗
• MalfunctionDec 19, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE NEEDLE IS COMING UNATTACHED FROM THE SUTURE. THE EXACT PASS OF THE SUTURE IS UNKNOWN WHEN THE SUTURE IS COMING APART FROM THE NEEDLE. CASE COMPLETED WITH LIKE DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356098 ↗
• MalfunctionDec 19, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE NEEDLE IS COMING UNATTACHED FROM THE SUTURE. THE EXACT PASS OF THE SUTURE IS UNKNOWN WHEN THE SUTURE IS COMING APART FROM THE NEEDLE. CASE COMPLETED WITH LIKE DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356097 ↗
• MalfunctionDec 19, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE NEEDLE IS COMING UNATTACHED FROM THE SUTURE. THE EXACT PASS OF THE SUTURE IS UNKNOWN WHEN THE SUTURE IS COMING APART FROM THE NEEDLE. CASE COMPLETED WITH LIKE DEVICE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356088 ↗
• MalfunctionSep 14, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17750107 ↗
• MalfunctionApr 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ANASTOMOSIS PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER REPORTS THAT WITH THE NEW PACKAGING, THE 8741H SUTURE HAS THIS PROBLEM: THE NEEDLE DETACHES VERY EASILY FROM THE SUTURE, CREATING CONSIDERABLE INCONVENIENCE AND LITTLE SAFETY, BEING SUTURES DELICATE AND OFTEN USED IN PEDIATRIC PATIENTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765879 ↗
• MalfunctionApr 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ANASTOMOSIS PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER REPORTS THAT WITH THE NEW PACKAGING, THE 8741H SUTURE HAS THIS PROBLEM: THE NEEDLE DETACHES VERY EASILY FROM THE SUTURE, CREATING CONSIDERABLE INCONVENIENCE AND LITTLE SAFETY, BEING SUTURES DELICATE AND OFTEN USED IN PEDIATRIC PATIENTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765868 ↗
• MalfunctionApr 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ANASTOMOSIS PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER REPORTS THAT WITH THE NEW PACKAGING, THE 8741H SUTURE HAS THIS PROBLEM: THE NEEDLE DETACHES VERY EASILY FROM THE SUTURE, CREATING CONSIDERABLE INCONVENIENCE AND LITTLE SAFETY, BEING SUTURES DELICATE AND OFTEN USED IN PEDIATRIC PATIENTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765860 ↗
• MalfunctionApr 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ANASTOMOSIS PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER REPORTS THAT WITH THE NEW PACKAGING, THE 8741H SUTURE HAS THIS PROBLEM: THE NEEDLE DETACHES VERY EASILY FROM THE SUTURE, CREATING CONSIDERABLE INCONVENIENCE AND LITTLE SAFETY, BEING SUTURES DELICATE AND OFTEN USED IN PEDIATRIC PATIENTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765832 ↗
• MalfunctionApr 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ANASTOMOSIS PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER REPORTS THAT WITH THE NEW PACKAGING, THE 8741H SUTURE HAS THIS PROBLEM: THE NEEDLE DETACHES VERY EASILY FROM THE SUTURE, CREATING CONSIDERABLE INCONVENIENCE AND LITTLE SAFETY, BEING SUTURES DELICATE AND OFTEN USED IN PEDIATRIC PATIENTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765827 ↗
• MalfunctionApr 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ANASTOMOSIS PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER REPORTS THAT WITH THE NEW PACKAGING, THE 8741H SUTURE HAS THIS PROBLEM: THE NEEDLE DETACHES VERY EASILY FROM THE SUTURE, CREATING CONSIDERABLE INCONVENIENCE AND LITTLE SAFETY, BEING SUTURES DELICATE AND OFTEN USED IN PEDIATRIC PATIENTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765814 ↗

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-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• 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-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647

…and 6 more.