PROLENE 8726HRecalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10705031019805), received between Oct 15, 2019 and Jul 2, 2026 — classified as 1 death, 46 malfunctions.

The most frequently reported specific device problem is “Break” (28 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANASTOMOSIS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SEVERAL 6-0 SUTURES KEPT BREAKING DURING ANASTOMOSIS WITH NO CAUSE. SCRUB NURSE/SURGEON SUSPECT THAT SUTURES WERE FAULTY AS IT WOULD BREAK VERY EASILY. SUTURES WERE NOT EXPIRED HOWEVER NOTICED ALL THE FAULTY SUTURES (3 SUTURE PACKS) WERE FROM SAME. REMOVED THESE SUTURES FROM OPERATING ROOM PYXIS. NEW PACKS OPENED AND USED WITH DIFFERENT LOT NUMBER. NO ISSUES NOTED WITH THESE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25697723 ↗
• MalfunctionJul 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANASTOMOSIS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SEVERAL 6-0 SUTURES KEPT BREAKING DURING ANASTOMOSIS WITH NO CAUSE. SCRUB NURSE/SURGEON SUSPECT THAT SUTURES WERE FAULTY AS IT WOULD BREAK VERY EASILY. SUTURES WERE NOT EXPIRED HOWEVER NOTICED ALL THE FAULTY SUTURES (3 SUTURE PACKS) WERE FROM SAME. REMOVED THESE SUTURES FROM OPERATING ROOM PYXIS. NEW PACKS OPENED AND USED WITH DIFFERENT LOT NUMBER. NO ISSUES NOTED WITH THESE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25697645 ↗
• MalfunctionJun 23, 2026Material Separation; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A VASCULAR PROCEDURE, MULTIPLE SUTURES FROM THE SAME PACKAGE DETACHED FROM THE NEEDLE. THEY DON'T KNOW HOW MANY SUTURES WERE OPEN OR USED. THE USER INDICATED THAT WHILE PASSING THE SUTURE, IT DID NOT FEEL NORMAL AND REQUIRED MORE FORCE THAN EXPECTED. THE SUTURE WAS DESCRIBED AS FEELING DIFFERENT COMPARED TO TYPICAL USE, AND UPON PULLING THROUGH, IT SNAPPED. NO PATIENT CONSEQUENCES WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25595607 ↗
• MalfunctionJun 23, 2026Material Separation; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A VASCULAR PROCEDURE, MULTIPLE SUTURES FROM THE SAME PACKAGE DETACHED FROM THE NEEDLE. THEY DON'T KNOW HOW MANY SUTURES WERE OPEN OR USED. THE USER INDICATED THAT WHILE PASSING THE SUTURE, IT DID NOT FEEL NORMAL AND REQUIRED MORE FORCE THAN EXPECTED. THE SUTURE WAS DESCRIBED AS FEELING DIFFERENT COMPARED TO TYPICAL USE, AND UPON PULLING THROUGH, IT SNAPPED. NO PATIENT CONSEQUENCES WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25595605 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE ACCOUNT CONTACT THAT, DURING UNSPECIFIED PROCEDURE, THE SUTURE WAS BREAKING. THEY PULLED ANOTHER ONE AND IT WORKED FINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. 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 23293860 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ENDARECTOMY (RT) PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT THE SURGEON STATED THAT THE SUTURE BREAKS RANDOMLY. THE SURGEON WAS WORRIED THAT HE MIGHT LOSE THE NEEDLE. STERILE SAMPLES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22718884 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ENDARECTOMY (RT) PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT THE SURGEON STATED THAT THE SUTURE BREAKS RANDOMLY. THE SURGEON WAS WORRIED THAT HE MIGHT LOSE THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. STERILE SAMPLES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22718866 ↗
• MalfunctionJan 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON DURING THE CASE THESE SUTURES WERE SNAPPING IN HALF AND SEEMED TO BE BRITTLE. DEVICES WERE RETURNING. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21152668 ↗
• MalfunctionJan 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON DURING THE CASE THESE SUTURES WERE SNAPPING IN HALF AND SEEMED TO BE BRITTLE. DEVICES WERE RETURNING. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21152667 ↗
• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG AND AORTIC VALVE REPLACEMENT ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED TWICE IN THE MIDDLE WHEN THEY WERE TRYING TO TIE THE HEART STRING INTO THE HEART. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20897215 ↗
• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG AND AORTIC VALVE REPLACEMENT ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED IN THE MIDDLE WHEN THEY WERE TRYING TO TIE THE HEART STRING INTO THE HEART. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20896668 ↗
• MalfunctionNov 18, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFTING PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING CONTINUOUS SUTURING, THE SUTURE BREAKAGE OCCURRED AT A DIFFERENT POINT FROM THE LIGATURE POINT DURING LIGATION. IT WAS NOT A CONTROL RELEASE NEEDLE. IT WAS USED ON BLOOD VESSEL. 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 20709037 ↗
• MalfunctionMar 5, 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 WOULD BREAK WHEN THE DOCTOR WAS TYING IT DURING A VESICULAR/CARDIOVASCULAR PROCEDURE. THEY OPENED A DIFFERENT LOT NUMBER TO COMPLETE THE CASE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838492 ↗
• MalfunctionOct 11, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2023 AND SUTURE WAS USED. WHILE DOING SURGERY THE SUTURE NEEDLES HAD POPPED. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916015 ↗
• MalfunctionOct 11, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2023 AND SUTURE WAS USED. WHILE DOING SURGERY THE SUTURE NEEDLES HAD POPPED. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916012 ↗
• MalfunctionSep 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC BYPASS PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE BROKE EASILY. IT HAPPENED AT LEAST 2 TIMES WHERE THE SUTURE WOULD POP OFF WHILE SUTURING, INTRA-OPERATIVELY. SWITCHED BOXES AND THE PROBLEM STOPPED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17834805 ↗
• MalfunctionSep 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC BYPASS PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE BROKE EASILY. IT HAPPENED AT LEAST 2 TIMES WHERE THE SUTURE WOULD POP OFF WHILE SUTURING, INTRA-OPERATIVELY. SWITCHED BOXES AND THE PROBLEM STOPPED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17834462 ↗
• MalfunctionJan 12, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD WAS DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16151040 ↗
• MalfunctionNov 10, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. TWO SUTURES OUT OF THREE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15776717 ↗
• MalfunctionNov 10, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. TWO SUTURES OUT OF THREE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15776097 ↗
• MalfunctionSep 16, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD POPPED OFF THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15436991 ↗
• MalfunctionSep 16, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD POPPED OFF THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15436989 ↗
• MalfunctionSep 14, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. AT FIRST APPEARANCE, TWO NEEDLES WERE VISIBLE AS USUAL, BUT WHEN THE NEEDLE HOLDER GRASPED THE NEEDLE AND PULLED OUT THE SUTURE, ONE NEEDLE WITH A SUTURE CAME OUT FROM THE INSIDE. THERE WAS ONE DOUBLE-ARMED SUTURE AND ONE SINGLE-ARMED SUTURE IN THE PACKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422809 ↗
• MalfunctionSep 2, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS EASILY DETACHED FROM THE SUTURE. 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 15352330 ↗
• MalfunctionSep 2, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS EASILY DETACHED FROM THE SUTURE. 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 15352311 ↗

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-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• 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-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• 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-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748

…and 6 more.