PROLENE 8706HRecalls & reported problems

Summary

The FDA's MAUDE database contains 294 adverse event reports that list this exact device (DI 10705031019430), received between Mar 28, 2019 and Sep 30, 2026 — classified as 4 injuries, 290 malfunctions.

The most frequently reported specific device problem is “Break” (179 reports).

2 FDA recall records name this device's identifier, 2 still open.

19 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.

Recalls naming this device

1. Mar 7, 2025Open, Classified

   Identified curing issues with the silicone during the needles manufacturing process.

   Z-1515-2025 · Root cause: Process control · Recall details · FDA record ↗

2. Dec 20, 2024Open, Classified

   Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

   Z-1096-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 294 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Separation

  It was reported that a patient underwent a CABG procedure on an unknown date and suture was used. During CABG procedure, needle popped off the suture when pulling up on the shod. This is the second time this has happened with a suture in the last week. Different lot number. Nothing changed with surgeon's technique, just gently pulled up on the suture and the needle popped off easily. Had to bring in X-Ray to find. No patient harmed. The rep pulled the whole box off shelf and requesting replacement box sent. There was 10min of surgical delay reported. Device availability unknown. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948676 ↗
• MalfunctionSep 30, 2026Material Separation

  It was reported that a patient underwent a CABG procedure on (b)(6)2026 and suture was used. During CABG procedure, needle popped off the suture when pulling up on the shod. This is the second time this has happened with a suture in the last week. Different lot number. Nothing changed with surgeon's technique, just gently pulled up on the suture and the needle popped off easily. Had to bring in X-Ray to find. No patient harmed. The rep pulled the whole box off shelf and requesting replacement box sent. There was 10min of surgical delay reported. Device availability unknown. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947522 ↗
• MalfunctionSep 18, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6)2026 and suture was used. The suture thread was breaking. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828730 ↗
• MalfunctionSep 18, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. The suture thread was breaking. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828700 ↗
• MalfunctionAug 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50307684 ↗
• MalfunctionAug 13, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50235699 ↗
• MalfunctionAug 13, 2026Material Separation

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. The suture deswaged on routine use. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50235691 ↗
• MalfunctionAug 13, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50235684 ↗
• MalfunctionAug 13, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50235654 ↗
• MalfunctionMay 28, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR DEBRIDEMENT AND SUTURING SURGERY. IMMEDIATELY CHANGED ANOTHER ONE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25321065 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE OPERATION PROCESS, MULTIPLE WIRES HAVE BEEN BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717396 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE OPERATION PROCESS, MULTIPLE WIRES HAVE BEEN BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716107 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SEVERAL ATTEMPTS WERE MADE WITH THIS LOT NUMBER, 4 OF THE 4 SUTURES BROKE UNDER TENSION. DOCTOR NO LONGER WANTED THE BOX IN THE ROOM AND EVENTUALLY USED THE SAME ARTICLE NUMBER (DIFFERENT BOX) THAT FUNCTIONED AS DESIRED. THE DOCTOR COULD NOT SUTURE SO THE WOUND REMAINED OPEN, EVENTUALLY THE CIRCULATION GOT A NEW BOX AND OPENED IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24703958 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SEVERAL ATTEMPTS WERE MADE WITH THIS LOT NUMBER, 4 OF THE 4 SUTURES BROKE UNDER TENSION. DOCTOR NO LONGER WANTED THE BOX IN THE ROOM AND EVENTUALLY USED THE SAME ARTICLE NUMBER (DIFFERENT BOX) THAT FUNCTIONED AS DESIRED. THE DOCTOR COULD NOT SUTURE SO THE WOUND REMAINED OPEN, EVENTUALLY THE CIRCULATION GOT A NEW BOX AND OPENED IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24703797 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SEVERAL ATTEMPTS WERE MADE WITH THIS LOT NUMBER, 4 OF THE 4 SUTURES BROKE UNDER TENSION. DOCTOR NO LONGER WANTED THE BOX IN THE ROOM AND EVENTUALLY USED THE SAME ARTICLE NUMBER (DIFFERENT BOX) THAT FUNCTIONED AS DESIRED. THE DOCTOR COULD NOT SUTURE SO THE WOUND REMAINED OPEN, EVENTUALLY THE CIRCULATION GOT A NEW BOX AND OPENED IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24703713 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SEVERAL ATTEMPTS WERE MADE WITH THIS LOT NUMBER, 4 OF THE 4 SUTURES BROKE UNDER TENSION. DOCTOR NO LONGER WANTED THE BOX IN THE ROOM AND EVENTUALLY USED THE SAME ARTICLE NUMBER (DIFFERENT BOX) THAT FUNCTIONED AS DESIRED. THE DOCTOR COULD NOT SUTURE SO THE WOUND REMAINED OPEN, EVENTUALLY THE CIRCULATION GOT A NEW BOX AND OPENED IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24703612 ↗
• MalfunctionFeb 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE AND SUTURE WAS EASILY DETACHED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456371 ↗
• MalfunctionFeb 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE AND SUTURE WAS EASILY DETACHED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456370 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT UNDERWENT TRAUMA SUTURING USING SUTURE DURING THE OPERATION. THE PATIENT CAME TO THE HOSPITAL THE NEXT DAY TO CHANGE DRESSING AND FOUND THAT THE SUTURES WERE BROKEN. AS BOTH THE SUBCUTANEOUS AND ENDOTHELIAL LAYERS HAD BEEN SUTURED AND THE SKIN FLAPS WERE ALIGNED NEATLY, NO TREATMENT WAS GIVEN. LATER, THE WOUND WAS CLOSELY OBSERVED AND HEALED WELL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223861 ↗
• InjuryJan 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ENDARECTOMY (RT) ON AN UNKNOWN DATE AND SUTURE WAS USED FOR INTERNAL CAROTID ARTERY CLOSURE. POST-OP, 24-48 HOURS AFTER THE PROCEDURE, THE PATIENT NEEDED TO BE BROUGHT BACK FOR A SECONDARY PROCEDURE TO REPAIR THE SUTURE. THE SUTURE HAD SPLIT IN HALF SEVERAL DAYS AFTER THE OPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24037553 ↗
• InjuryJan 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ENDARECTOMY (RT) ON (B)(6) 2025 AND SUTURE WAS USED FOR INTERNAL CAROTID ARTERY CLOSURE. POST-OP, 24-48 HOURS AFTER THE PROCEDURE, THE PATIENT NEEDED TO BE BROUGHT BACK FOR A SECONDARY PROCEDURE TO REPAIR THE SUTURE. THE SUTURE HAD SPLIT IN HALF SEVERAL DAYS AFTER THE OPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24037172 ↗
• MalfunctionJan 5, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE DETACHED FROM THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959017 ↗
• MalfunctionNov 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ENDARTERECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. A HIGHLY EXPERIENCED VASCULAR SURGEON, USED ARTICLE 8706 FOR CAROTID SUTURES. UNFORTUNATELY, THEY COULDN'T GIVE ME A SPECIFIC DATE FOR THE SURGERY. HE'S BEEN COMPLAINING FOR MONTHS THAT THE NEEDLES KEEP COMING LOOSE FROM THE THREAD, SOMETIMES EVEN DURING REMOVAL FROM THE WOUND SUPPORT. ALL PREVIOUS COMPLAINTS HAVE BEEN INCONCLUSIVE, WHICH ANNOYS HIM GREATLY. THE DOCTOR A HIGHLY EXPERIENCED AND ACCOMPLISHED VASCULAR SURGEON AND HAS ALWAYS BEEN VERY SATISFIED WITH OUR SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568948 ↗
• MalfunctionNov 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ENDARTERECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. A HIGHLY EXPERIENCED VASCULAR SURGEON, USED ARTICLE 8706 FOR CAROTID SUTURES. UNFORTUNATELY, THEY COULDN'T GIVE ME A SPECIFIC DATE FOR THE SURGERY. HE'S BEEN COMPLAINING FOR MONTHS THAT THE NEEDLES KEEP COMING LOOSE FROM THE THREAD, SOMETIMES EVEN DURING REMOVAL FROM THE WOUND SUPPORT. ALL PREVIOUS COMPLAINTS HAVE BEEN INCONCLUSIVE, WHICH ANNOYS HIM GREATLY. THE DOCTOR A HIGHLY EXPERIENCED AND ACCOMPLISHED VASCULAR SURGEON AND HAS ALWAYS BEEN VERY SATISFIED WITH OUR SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568942 ↗
• MalfunctionNov 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ENDARTERECTOMY ON 2025 AND SUTURE WAS USED. A HIGHLY EXPERIENCED VASCULAR SURGEON, USED ARTICLE 8706 FOR CAROTID SUTURES. UNFORTUNATELY, THEY COULDN'T GIVE ME A SPECIFIC DATE FOR THE SURGERY. HE'S BEEN COMPLAINING FOR MONTHS THAT THE NEEDLES KEEP COMING LOOSE FROM THE THREAD, SOMETIMES EVEN DURING REMOVAL FROM THE WOUND SUPPORT. ALL PREVIOUS COMPLAINTS HAVE BEEN INCONCLUSIVE, WHICH ANNOYS HIM GREATLY. THE DOCTOR A HIGHLY EXPERIENCED AND ACCOMPLISHED VASCULAR SURGEON AND HAS ALWAYS BEEN VERY SATISFIED WITH OUR SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568940 ↗

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-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• 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-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• 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-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-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631

…and 4 more.