PROLENE W8704Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 10705031128248), received between Jun 11, 2024 and Sep 30, 2026 — classified as 1 injury, 63 malfunctions.

The most frequently reported specific device problem is “Break” (48 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 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950505 ↗
• MalfunctionSep 30, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. After suturing the blood vessel, the thread broke directly at the final knot. There were no adverse patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950500 ↗
• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950499 ↗
• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950494 ↗
• MalfunctionAug 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50299613 ↗
• MalfunctionAug 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50299611 ↗
• MalfunctionAug 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286713 ↗
• MalfunctionAug 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286701 ↗
• MalfunctionJun 18, 2026Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6)2026 AND SUTURE WAS USED. THE SUTURE DETACHED FROM THE NEEDLE, AND THE THREAD BROKE DURING KNOT TYING, NECESSITATING REMOVAL AND REPLACEMENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO SURGICAL DELAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 25552430 ↗
• MalfunctionJun 18, 2026Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE DETACHED FROM THE NEEDLE, AND THE THREAD BROKE DURING KNOT TYING, NECESSITATING REMOVAL AND REPLACEMENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO SURGICAL DELAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 25552429 ↗
• MalfunctionJun 18, 2026Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE DETACHED FROM THE NEEDLE, AND THE THREAD BROKE DURING KNOT TYING, NECESSITATING REMOVAL AND REPLACEMENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO SURGICAL DELAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 25552428 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXTRACARDIAC BYPASS PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IN SURGERY, WHEN SEWING FOR DISTAL ANASTOMOSIS WITH CONTINUOUS SEWING OF BLOOD VESSELS, THREE SUTURES BROKEN CONSECUTIVELY, WHICH CAUSED BLEEDING. THE BLEEDING VOLUME WAS NOT CONFIRMED. CHANGED ANOTHER SUTURE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25218378 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXTRACARDIAC BYPASS PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IN SURGERY, WHEN SEWING FOR DISTAL ANASTOMOSIS WITH CONTINUOUS SEWING OF BLOOD VESSELS, THREE SUTURES BROKEN CONSECUTIVELY, WHICH CAUSED BLEEDING. THE BLEEDING VOLUME WAS NOT CONFIRMED. CHANGED ANOTHER SUTURE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25218187 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXTRACARDIAC BYPASS PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IN SURGERY, WHEN SEWING FOR DISTAL ANASTOMOSIS WITH CONTINUOUS SEWING OF BLOOD VESSELS, THREE SUTURES BROKEN CONSECUTIVELY, WHICH CAUSED BLEEDING. THE BLEEDING VOLUME WAS NOT CONFIRMED. CHANGED ANOTHER SUTURE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25218142 ↗
• MalfunctionMay 19, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SURGICAL SUTURING PROCESS, THE DOCTOR FOUND THAT THE SUTURE AND NEEDLE HAD FALLEN OFF AFTER ONE STITCH WAS SUTURED. THE DOCTOR REPLACED THE SUTURE WITH A NEW ONE AND RE SUTURED IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218012 ↗
• MalfunctionFeb 5, 2026Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT WHEN PREPARING FOR SURGERY, IT WAS FOUND THAT THERE WAS ONE SUTURE MORE THAN EXPECTED IN THE PACKAGE WITHOUT OPENING IT. THERE SHOULD BE 2 SUTURES IN THE PACKAGE, BUT ACTUALLY THERE WERE 3 SUTURES. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270594 ↗
• MalfunctionSep 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE PREFORMING HAEMOSTASIS ON UR FIRST LSITED PATIENT THE VASCULAR REGISTRAR USED TWO 7-0 PROLENE 9.3 CC NEEDLE. THESE TWO NEEDLES SNAPPED AND PULLED APART UPON TYING. THE ONLY INSTRUMENT USED WAS A RACHETED NEEDLE HOLDER ON THE NEEDLE ITSELF. THERE WAS NOTHING USED ON THE THREAD, THE FIRST SUTURE SEEMED TO JUST FALL APART IN THEIR HANDS. IT WAS NOTICED THAT THE SUTURES WEREFROM THE SAME BATCH. THIS IS NOT A NEW OCCURANCE, WE HAVE HAD MULTIPLE AT THE START OF THIS YEAR AND CURRENTLY ONE OPEN INVESTIGATION ON A 3-0 PROLENE. WHAT WERE THE IMMEDIATE ACTIONS TAKEN? : THE SUTURES WERE REMOVED FROM THE FIELD WITH THE NEEDLES ATTACHED AND THE CORRESPONDING PACKETS. LABLED WITH DATE, SURGEON AND CASE NUMBER. UFORTUNATELY AFTER TWO BREAKING THE SURGEON CHOSE DIFFERENT MEASURES OF HAEMOSTASIS. AS DETAILED ABOVE THE SUTURES WERE FROM THE SAME LOT/BATCH, THE REMAINING SUTURES WITH THE MATCHING WERE REMOVED FROM OURSHELF. AER COMPLETED AND AN EMAIL WILL BE SENT TO CLINICAL ENGINEER TEAM AND THE COMPANY REP. THE SUTURES WILL BE MADE AVAILABLE FOR THE CLINICAL ENGINEERING TE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23126279 ↗
• MalfunctionSep 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE PREFORMING HAEMOSTASIS ON UR FIRST LSITED PATIENT THE VASCULAR REGISTRAR USED TWO 7-0 PROLENE 9.3 CC NEEDLE. THESE TWO NEEDLES SNAPPED AND PULLED APART UPON TYING. THE ONLY INSTRUMENT USED WAS A RATCHETED NEEDLE HOLDER ON THE NEEDLE ITSELF. THERE WAS NOTHING USED ON THE THREAD, THE FIRST SUTURE SEEMED TO JUST FALL APART IN THEIR HANDS. IT WAS NOTICED THAT THE SUTURES WERE FROM THE SAME BATCH. THIS IS NOT A NEW OCCURENCE, WE HAVE HAD MULTIPLE AT THE START OF THIS YEAR AND CURRENTLY ONE OPEN INVESTIGATION ON A 3-0 PROLENE. WHAT WERE THE IMMEDIATE ACTIONS TAKEN? : THE SUTURES WERE REMOVED FROM THE FIELD WITH THE NEEDLES ATTACHED AND THE CORRESPONDING PACKETS. LABELED WITH DATE, SURGEON AND CASE NUMBER. UNFORTUNATELY AFTER TWO BREAKING THE SURGEON CHOSE DIFFERENT MEASURES OF HAEMOSTASIS. AS DETAILED ABOVE THE SUTURES WERE FROM THE SAME LOT/BATCH, THE REMAINING SUTURES WITH THE MATCHING WERE REMOVED FROM OUR SELF. AER COMPLETED AND AN EMAIL WILL BE SENT TO CLINICAL ENGINEER TEAM AND THE COMPANY REP. THE SUTURES WILL BE MADE AVAILABLE FOR THE CLINICAL ENGINEERIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23126275 ↗
• MalfunctionAug 25, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING VASCULAR SURGERY, 4 NEEDLES LOOSENED AND A WIRE BROKE. ALL OF THE SAME BATCH. USE OF ANOTHER BATCH AVAILABLE, WHICH MADE IT POSSIBLE TO FINISH THE PROCEDURE WITHOUT CONSEQUENCES FOR THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882532 ↗
• MalfunctionAug 25, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING VASCULAR SURGERY, 4 NEEDLES LOOSENED AND A WIRE BROKE¿ALL OF THE SAME BATCH. USE OF ANOTHER BATCH AVAILABLE, WHICH MADE IT POSSIBLE TO FINISH THE PROCEDURE WITHOUT CONSEQUENCES FOR THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882527 ↗
• MalfunctionAug 25, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING VASCULAR SURGERY, 4 NEEDLES LOOSENED AND A WIRE BROKE. ALL OF THE SAME BATCH. USE OF ANOTHER BATCH AVAILABLE, WHICH MADE IT POSSIBLE TO FINISH THE PROCEDURE WITHOUT CONSEQUENCES FOR THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882526 ↗
• MalfunctionAug 25, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING VASCULAR SURGERY, 4 NEEDLES LOOSENED AND A WIRE BROKE. ALL OF THE SAME BATCH. USE OF ANOTHER BATCH AVAILABLE, WHICH MADE IT POSSIBLE TO FINISH THE PROCEDURE WITHOUT CONSEQUENCES FOR THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882519 ↗
• MalfunctionAug 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT WAS TREATED FOR THROMBOENDARTERECTOMY BY EVERSION OF THE RIGHT INTERNAL CAROTID ARTERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE ANASTOMOSIS, THE NEEDLE LOOSENED AND FELL ONTO THE SURGICAL FIELD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22865357 ↗
• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING THE OPERATION. THERE WAS NO DELAY IN SURGERY DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206208 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AV CANAL REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THE SURGEON USED THE DEVICE*2EA TO SUTURE, THIS SUTURE WAS BROKEN. THE BREAKPOINT IN THE JUNCTION BETWEEN NEEDLE AND SUTURE. THEN, HE USED OTHER LOT NUMBER TO COMPLETE THIS PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079578 ↗

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-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• 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-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995

…and 6 more.