PROLENE 8747HRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705031020122), received between Jun 14, 2022 and Apr 16, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE UNDERGONE SUTURE BREAKAGE DURING THE CARDIAC SURGERY WHILE DOING DISTAL ANASTOMOSIS. THE SUTURE GOT DETACHED FROM SWAGE POINT. DURING THE SURGERY 2 FOILS AFFECTED AND HOSPITAL HAS REQUESTED TO REPLACE THE REMAINING 13 FOILS ON PRIORITY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SURGICAL DELAYS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895805 ↗
• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE UNDERGONE SUTURE BREAKAGE DURING THE CARDIAC SURGERY WHILE DOING DISTAL ANASTOMOSIS. THE SUTURE GOT DETACHED FROM SWAGE POINT. DURING THE SURGERY 2 FOILS AFFECTED AND HOSPITAL HAS REQUESTED TO REPLACE THE REMAINING 13 FOILS ON PRIORITY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SURGICAL DELAYS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895803 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT OVER THE PAST COUPLE WEEKS DURING FIVE HEART PROCEDURES TWO TO THREE SUTURES WOULD BREAK WHILE SUTURING THE ANASTOMOSIS. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE TILL COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. EIGHT STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026627 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT OVER THE PAST COUPLE WEEKS DURING FIVE HEART PROCEDURES TWO TO THREE SUTURES WOULD BREAK WHILE SUTURING THE ANASTOMOSIS. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE TILL COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. EIGHT STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026552 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT OVER THE PAST COUPLE WEEKS DURING FIVE HEART PROCEDURES TWO TO THREE SUTURES WOULD BREAK WHILE SUTURING THE ANASTOMOSIS. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE TILL COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. EIGHT STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026543 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT OVER THE PAST COUPLE WEEKS DURING FIVE HEART PROCEDURES TWO TO THREE SUTURES WOULD BREAK WHILE SUTURING THE ANASTOMOSIS. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE TILL COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. EIGHT STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026467 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT OVER THE PAST COUPLE WEEKS DURING FIVE HEART PROCEDURES TWO TO THREE SUTURES WOULD BREAK WHILE SUTURING THE ANASTOMOSIS. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE TILL COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. EIGHT STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026340 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT OVER THE PAST COUPLE WEEKS DURING FIVE HEART PROCEDURES TWO TO THREE SUTURES WOULD BREAK WHILE SUTURING THE ANASTOMOSIS. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE TILL COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. EIGHT STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026279 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT OVER THE PAST COUPLE WEEKS DURING FIVE HEART PROCEDURES TWO TO THREE SUTURES WOULD BREAK WHILE SUTURING THE ANASTOMOSIS. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE TILL COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. EIGHT STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026211 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT OVER THE PAST COUPLE WEEKS DURING FIVE HEART PROCEDURES TWO TO THREE SUTURES WOULD BREAK WHILE SUTURING THE ANASTOMOSIS. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE TILL COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. EIGHT STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026191 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT OVER THE PAST COUPLE WEEKS DURING FIVE HEART PROCEDURES TWO TO THREE SUTURES WOULD BREAK WHILE SUTURING THE ANASTOMOSIS. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE TILL COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. EIGHT STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025996 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT OVER THE PAST COUPLE WEEKS DURING FIVE HEART PROCEDURES TWO TO THREE SUTURES WOULD BREAK WHILE SUTURING THE ANASTOMOSIS. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE TILL COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. EIGHT STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025995 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT OVER THE PAST COUPLE WEEKS DURING FIVE HEART PROCEDURES TWO TO THREE SUTURES WOULD BREAK WHILE SUTURING THE ANASTOMOSIS. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE TILL COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. EIGHT STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025829 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT OVER THE PAST COUPLE WEEKS DURING FIVE HEART PROCEDURES TWO TO THREE SUTURES WOULD BREAK WHILE SUTURING THE ANASTOMOSIS. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE TILL COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. EIGHT STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025818 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT OVER THE PAST COUPLE WEEKS DURING FIVE HEART PROCEDURES TWO TO THREE SUTURES WOULD BREAK WHILE SUTURING THE ANASTOMOSIS. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE TILL COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. EIGHT STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025816 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT OVER THE PAST COUPLE WEEKS DURING FIVE HEART PROCEDURES TWO TO THREE SUTURES WOULD BREAK WHILE SUTURING THE ANASTOMOSIS. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE TILL COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. EIGHT STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025676 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT OVER THE PAST COUPLE WEEKS DURING FIVE HEART PROCEDURES TWO TO THREE SUTURES WOULD BREAK WHILE SUTURING THE ANASTOMOSIS. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE TILL COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. EIGHT STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025675 ↗
• MalfunctionSep 20, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE NEEDLE IS VERY EASILY POPPING OFF OF THE SUTURE. NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17782903 ↗
• MalfunctionSep 20, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE NEEDLE IS VERY EASILY POPPING OFF OF THE SUTURE. NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17782878 ↗
• MalfunctionJun 14, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14684340 ↗

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-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• 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
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• 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-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• 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

…and 6 more.