PROLENE W2777Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10705031126039), received between Jun 14, 2024 and Sep 30, 2026 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Break” (32 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. The suture was broken when the surgeon attempted to sew the tissue. A Total of six products had the issue suture breakage occur. 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 50945386 ↗
• MalfunctionSep 30, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. The suture was broken when the surgeon attempted to sew the tissue. A Total of six products had the issue suture breakage occur. 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 50945360 ↗
• MalfunctionSep 30, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6)2026 and suture was used. The suture was broken when the surgeon attempted to sew the tissue. A Total of six products had the issue suture breakage occur. 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 50945331 ↗
• MalfunctionSep 30, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. The suture was broken when the surgeon attempted to sew the tissue. A Total of six products had the issue suture breakage occur. 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 50945330 ↗
• MalfunctionSep 30, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. The suture was broken when the surgeon attempted to sew the tissue. A Total of six products had the issue suture breakage occur. 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 50945295 ↗
• MalfunctionSep 30, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. The suture was broken when the surgeon attempted to sew the tissue. A Total of six products had the issue suture breakage occur. 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 50945278 ↗
• MalfunctionApr 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 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 24932287 ↗
• MalfunctionApr 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE BROKE WHEN SEWING IN AN UNKNOWN SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE ACTUAL SAMPLE CAN'T BE RETURNED, 2 ACTUAL SAMPLES WERE DISCARD, BUT 20 STERILE SAMPLES FROM SAME BATCH WILL BE RETURNED FOR ANALYSIS. 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 24871977 ↗
• MalfunctionApr 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE BROKE WHEN SEWING IN AN UNKNOWN SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE ACTUAL SAMPLE CAN'T BE RETURNED, 2 ACTUAL SAMPLES WERE DISCARD, BUT 20 STERILE SAMPLES FROM SAME BATCH WILL BE RETURNED FOR ANALYSIS. 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 24871976 ↗
• MalfunctionFeb 13, 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 THAT THE NEEDLE BROKE WHEN SEWING IN 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 24337312 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE DOCTOR USED SUTURE TO ANASTOMOSE BLOOD VESSELS DURING THE SURGERY. A TOTAL OF 29 PACKS OF THIS SUTURE WERE USED THROUGHOUT THE ENTIRE PROCESS, BUT 19 PACKS BROKE DURING THE SUTURING PROCESS. THE BROKEN SUTURES HAVE NOT BEEN USED AGAIN, AND NEW SUTURES HAVE BEEN REPLACED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015371 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE DOCTOR USED SUTURE TO ANASTOMOSE BLOOD VESSELS DURING THE SURGERY. A TOTAL OF 29 PACKS OF THIS SUTURE WERE USED THROUGHOUT THE ENTIRE PROCESS, BUT 19 PACKS BROKE DURING THE SUTURING PROCESS. THE BROKEN SUTURES HAVE NOT BEEN USED AGAIN, AND NEW SUTURES HAVE BEEN REPLACED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015361 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE DOCTOR USED SUTURE TO ANASTOMOSE BLOOD VESSELS DURING THE SURGERY. A TOTAL OF 29 PACKS OF THIS SUTURE WERE USED THROUGHOUT THE ENTIRE PROCESS, BUT 19 PACKS BROKE DURING THE SUTURING PROCESS. THE BROKEN SUTURES HAVE NOT BEEN USED AGAIN, AND NEW SUTURES HAVE BEEN REPLACED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015355 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE DOCTOR USED SUTURE TO ANASTOMOSE BLOOD VESSELS DURING THE SURGERY. A TOTAL OF 29 PACKS OF THIS SUTURE WERE USED THROUGHOUT THE ENTIRE PROCESS, BUT 19 PACKS BROKE DURING THE SUTURING PROCESS. THE BROKEN SUTURES HAVE NOT BEEN USED AGAIN, AND NEW SUTURES HAVE BEEN REPLACED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015341 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE DOCTOR USED SUTURE TO ANASTOMOSE BLOOD VESSELS DURING THE SURGERY. A TOTAL OF 29 PACKS OF THIS SUTURE WERE USED THROUGHOUT THE ENTIRE PROCESS, BUT 19 PACKS BROKE DURING THE SUTURING PROCESS. THE BROKEN SUTURES HAVE NOT BEEN USED AGAIN, AND NEW SUTURES HAVE BEEN REPLACED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015323 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE DOCTOR USED SUTURE TO ANASTOMOSE BLOOD VESSELS DURING THE SURGERY. A TOTAL OF 29 PACKS OF THIS SUTURE WERE USED THROUGHOUT THE ENTIRE PROCESS, BUT 19 PACKS BROKE DURING THE SUTURING PROCESS. THE BROKEN SUTURES HAVE NOT BEEN USED AGAIN, AND NEW SUTURES HAVE BEEN REPLACED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015314 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE DOCTOR USED SUTURE TO ANASTOMOSE BLOOD VESSELS DURING THE SURGERY. A TOTAL OF 29 PACKS OF THIS SUTURE WERE USED THROUGHOUT THE ENTIRE PROCESS, BUT 19 PACKS BROKE DURING THE SUTURING PROCESS. THE BROKEN SUTURES HAVE NOT BEEN USED AGAIN, AND NEW SUTURES HAVE BEEN REPLACED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015300 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE DOCTOR USED SUTURE TO ANASTOMOSE BLOOD VESSELS DURING THE SURGERY. A TOTAL OF 29 PACKS OF THIS SUTURE WERE USED THROUGHOUT THE ENTIRE PROCESS, BUT 19 PACKS BROKE DURING THE SUTURING PROCESS. THE BROKEN SUTURES HAVE NOT BEEN USED AGAIN, AND NEW SUTURES HAVE BEEN REPLACED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015268 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE DOCTOR USED SUTURE TO ANASTOMOSE BLOOD VESSELS DURING THE SURGERY. A TOTAL OF 29 PACKS OF THIS SUTURE WERE USED THROUGHOUT THE ENTIRE PROCESS, BUT 19 PACKS BROKE DURING THE SUTURING PROCESS. THE BROKEN SUTURES HAVE NOT BEEN USED AGAIN, AND NEW SUTURES HAVE BEEN REPLACED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015248 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE DOCTOR USED SUTURE TO ANASTOMOSE BLOOD VESSELS DURING THE SURGERY. A TOTAL OF 29 PACKS OF THIS SUTURE WERE USED THROUGHOUT THE ENTIRE PROCESS, BUT 19 PACKS BROKE DURING THE SUTURING PROCESS. THE BROKEN SUTURES HAVE NOT BEEN USED AGAIN, AND NEW SUTURES HAVE BEEN REPLACED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015235 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE DOCTOR USED SUTURE TO ANASTOMOSE BLOOD VESSELS DURING THE SURGERY. A TOTAL OF 29 PACKS OF THIS SUTURE WERE USED THROUGHOUT THE ENTIRE PROCESS, BUT 19 PACKS BROKE DURING THE SUTURING PROCESS. THE BROKEN SUTURES HAVE NOT BEEN USED AGAIN, AND NEW SUTURES HAVE BEEN REPLACED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015220 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE DOCTOR USED SUTURE TO ANASTOMOSE BLOOD VESSELS DURING THE SURGERY. A TOTAL OF 29 PACKS OF THIS SUTURE WERE USED THROUGHOUT THE ENTIRE PROCESS, BUT 19 PACKS BROKE DURING THE SUTURING PROCESS. THE BROKEN SUTURES HAVE NOT BEEN USED AGAIN, AND NEW SUTURES HAVE BEEN REPLACED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015170 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE DOCTOR USED SUTURE TO ANASTOMOSE BLOOD VESSELS DURING THE SURGERY. A TOTAL OF 29 PACKS OF THIS SUTURE WERE USED THROUGHOUT THE ENTIRE PROCESS, BUT 19 PACKS BROKE DURING THE SUTURING PROCESS. THE BROKEN SUTURES HAVE NOT BEEN USED AGAIN, AND NEW SUTURES HAVE BEEN REPLACED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015161 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE DOCTOR USED SUTURE TO ANASTOMOSE BLOOD VESSELS DURING THE SURGERY. A TOTAL OF (B)(4) PACKS OF THIS SUTURE WERE USED THROUGHOUT THE ENTIRE PROCESS, BUT 19 PACKS BROKE DURING THE SUTURING PROCESS. THE BROKEN SUTURES HAVE NOT BEEN USED AGAIN, AND NEW SUTURES HAVE BEEN REPLACED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015082 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE DOCTOR USED SUTURE TO ANASTOMOSE BLOOD VESSELS DURING THE SURGERY. A TOTAL OF 29 PACKS OF THIS SUTURE WERE USED THROUGHOUT THE ENTIRE PROCESS, BUT 19 PACKS BROKE DURING THE SUTURING PROCESS. THE BROKEN SUTURES HAVE NOT BEEN USED AGAIN, AND NEW SUTURES HAVE BEEN REPLACED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015077 ↗

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-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-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-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• 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-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-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189

…and 6 more.