PROLENE 8703HRecalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 10705031019348), received between Dec 24, 2019 and Sep 28, 2026 — classified as 102 malfunctions.

The most frequently reported specific device problem is “Break” (66 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 102 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923804 ↗
• MalfunctionSep 28, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916739 ↗
• MalfunctionSep 28, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916702 ↗
• MalfunctionSep 28, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916691 ↗
• MalfunctionSep 28, 2026Material Separation

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. Several defected 7-0 sutures had the Needles popping off the thread too easily. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916671 ↗
• MalfunctionSep 28, 2026Material Separation

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. Several defected 7-0 sutures had the Needles popping off the thread too easily. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916660 ↗
• MalfunctionJul 28, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50056924 ↗
• MalfunctionJul 15, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25825327 ↗
• MalfunctionJul 15, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25825323 ↗
• MalfunctionJul 15, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25825322 ↗
• MalfunctionJul 15, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25825321 ↗
• MalfunctionJul 15, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25825319 ↗
• MalfunctionMay 1, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CV CABG SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN CLOSING THE DISTAL ANASTOMOSIS, THE SUTURE BROKE, PULLED APART, FELL APART AND DISINTEGRATED. IT HAPPENED IN DIFFERENT PLACES ON EACH SUTURE, NOT WHERE THE NEEDLE AND SUTURE MEET THAT STAYED INTACT AND IT WAS NOT EXTRA TENSION ON THE SUTURE. THE PATIENT SHOWED BLEEDING ON THOSE ANASTOMOSIS SPOTS AND HEMOSTASIS PRODUCTS WERE USED ON TOP OF EACH SUTURE. ANOTHER LIKE DEVICE WAS USED TO FINISH THE CASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25055668 ↗
• MalfunctionMay 1, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CV CABG SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN CLOSING THE DISTAL ANASTOMOSIS, THE SUTURE BROKE, PULLED APART, FELL APART AND DISINTEGRATED. IT HAPPENED IN DIFFERENT PLACES ON EACH SUTURE, NOT WHERE THE NEEDLE AND SUTURE MEET THAT STAYED INTACT AND IT WAS NOT EXTRA TENSION ON THE SUTURE. THE PATIENT SHOWED BLEEDING ON THOSE ANASTOMOSIS SPOTS AND HEMOSTASIS PRODUCTS WERE USED ON TOP OF EACH SUTURE. ANOTHER LIKE DEVICE WAS USED TO FINISH THE CASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25055664 ↗
• MalfunctionMay 1, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CV CABG SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN CLOSING THE DISTAL ANASTOMOSIS, THE SUTURE BROKE, PULLED APART, FELL APART AND DISINTEGRATED. IT HAPPENED IN DIFFERENT PLACES ON EACH SUTURE, NOT WHERE THE NEEDLE AND SUTURE MEET THAT STAYED INTACT AND IT WAS NOT EXTRA TENSION ON THE SUTURE. THE PATIENT SHOWED BLEEDING ON THOSE ANASTOMOSIS SPOTS AND HEMOSTASIS PRODUCTS WERE USED ON TOP OF EACH SUTURE. ANOTHER LIKE DEVICE WAS USED TO FINISH THE CASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25055657 ↗
• MalfunctionMay 1, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CV CABG SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN CLOSING THE DISTAL ANASTOMOSIS, THE SUTURE BROKE, PULLED APART, FELL APART AND DISINTEGRATED. IT HAPPENED IN DIFFERENT PLACES ON EACH SUTURE, NOT WHERE THE NEEDLE AND SUTURE MEET THAT STAYED INTACT AND IT WAS NOT EXTRA TENSION ON THE SUTURE. THE PATIENT SHOWED BLEEDING ON THOSE ANASTOMOSIS SPOTS AND HEMOSTASIS PRODUCTS WERE USED ON TOP OF EACH SUTURE. ANOTHER LIKE DEVICE WAS USED TO FINISH THE CASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25055652 ↗
• MalfunctionApr 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE IN (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SURGEON TO THE SALES REP THAT MULTIPLE SUTURES WERE BREAKING. EVERY SUTURE THEY TRIED HAS BROKEN WHICH MEANS THIS HAPPENED MULTIPLE TIMES. NO OTHER INFORMATION PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24833500 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE SURGEON TO THE SALES REP THAT MULTIPLE SUTURES WERE BREAKING. EVERY SUTURE THEY TRIED HAS BROKEN WHICH MEANS THIS HAPPENED MULTIPLE TIMES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24815967 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT MULTIPLE SUTURES BROKE WHILE DOING ANASTOMOSIS ON THE HEART OR CAROTID TISSUE. THEY WOULD BREAK ANYWHERE FROM THREE THROWS IN TO HALFWAY AROUND THE ANASTOMOSIS. CUSTOMER REPORTS THAT THIS HAPPENED TO 3 OF THEIR 4 SURGEONS IN AT LEAST 5 CASES, BEFORE SUTURES WERE PULLED FROM THE SHELF. THEY BECAME AWARE OF THE ISSUE 2/5 & AGAIN ON 2/7 PULLING ALL THE BOXES ON 2/9. THERE IS NO PATIENT OR END-USER INJURY REPORTED. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706409 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT MULTIPLE SUTURES BROKE WHILE DOING ANASTOMOSIS ON THE HEART OR CAROTID TISSUE. THEY WOULD BREAK ANYWHERE FROM THREE THROWS IN TO HALFWAY AROUND THE ANASTOMOSIS. CUSTOMER REPORTS THAT THIS HAPPENED TO 3 OF THEIR 4 SURGEONS IN AT LEAST 5 CASES, BEFORE SUTURES WERE PULLED FROM THE SHELF. THEY BECAME AWARE OF THE ISSUE 2/5 & AGAIN ON 2/7 PULLING ALL THE BOXES ON 2/9. THERE IS NO PATIENT OR END-USER INJURY REPORTED. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698632 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT MULTIPLE SUTURES BROKE WHILE DOING ANASTOMOSIS ON THE HEART OR CAROTID TISSUE. THEY WOULD BREAK ANYWHERE FROM THREE THROWS IN TO HALFWAY AROUND THE ANASTOMOSIS. CUSTOMER REPORTS THAT THIS HAPPENED TO 3 OF THEIR 4 SURGEONS IN AT LEAST 5 CASES, BEFORE SUTURES WERE PULLED FROM THE SHELF. THEY BECAME AWARE OF THE ISSUE 2/5 & AGAIN ON 2/7 PULLING ALL THE BOXES ON 2/9. THERE IS NO PATIENT OR END-USER INJURY REPORTED. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698627 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT MULTIPLE SUTURES BROKE WHILE DOING ANASTOMOSIS ON THE HEART OR CAROTID TISSUE. THEY WOULD BREAK ANYWHERE FROM THREE THROWS IN TO HALFWAY AROUND THE ANASTOMOSIS. CUSTOMER REPORTS THAT THIS HAPPENED TO 3 OF THEIR 4 SURGEONS IN AT LEAST 5 CASES, BEFORE SUTURES WERE PULLED FROM THE SHELF. THEY BECAME AWARE OF THE ISSUE 2/5 & AGAIN ON 2/7 PULLING ALL THE BOXES ON 2/9. THERE IS NO PATIENT OR END-USER INJURY REPORTED. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698625 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT MULTIPLE SUTURES BROKE WHILE DOING ANASTOMOSIS ON THE HEART OR CAROTID TISSUE. THEY WOULD BREAK ANYWHERE FROM THREE THROWS IN TO HALFWAY AROUND THE ANASTOMOSIS. CUSTOMER REPORTS THAT THIS HAPPENED TO 3 OF THEIR 4 SURGEONS IN AT LEAST 5 CASES, BEFORE SUTURES WERE PULLED FROM THE SHELF. THEY BECAME AWARE OF THE ISSUE (B)(6) & AGAIN ON (B)(6) PULLING ALL THE BOXES ON (B)(6). THERE IS NO PATIENT OR END-USER INJURY REPORTED. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698617 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT MULTIPLE SUTURES BROKE WHILE DOING ANASTOMOSIS ON THE HEART OR CAROTID TISSUE. THEY WOULD BREAK ANYWHERE FROM THREE THROWS IN TO HALFWAY AROUND THE ANASTOMOSIS. CUSTOMER REPORTS THAT THIS HAPPENED TO 3 OF THEIR 4 SURGEONS IN AT LEAST 5 CASES, BEFORE SUTURES WERE PULLED FROM THE SHELF. THEY BECAME AWARE OF THE ISSUE 2/5 & AGAIN ON 2/7 PULLING ALL THE BOXES ON 2/9. THERE IS NO PATIENT OR END-USER INJURY REPORTED. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698583 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT MULTIPLE SUTURES BROKE WHILE DOING ANASTOMOSIS ON THE HEART OR CAROTID TISSUE. THEY WOULD BREAK ANYWHERE FROM THREE THROWS IN TO HALFWAY AROUND THE ANASTOMOSIS. CUSTOMER REPORTS THAT THIS HAPPENED TO 3 OF THEIR 4 SURGEONS IN AT LEAST 5 CASES, BEFORE SUTURES WERE PULLED FROM THE SHELF. THEY BECAME AWARE OF THE ISSUE 2/5 & AGAIN ON 2/7 PULLING ALL THE BOXES ON 2/9. THERE IS NO PATIENT OR END-USER INJURY REPORTED. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698582 ↗

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-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-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• 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-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746

…and 6 more.