PROLENE 8307HRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10705031014183), received between Apr 18, 2019 and Sep 28, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921110 ↗
• MalfunctionSep 28, 2026Material Separation

  It was reported a patient underwent an unknown procedure on an unknown date on 2026 and suture was used. The needle has come loose from the thread Clinical consequences: None as the surgeon was very vigilant. Change of the box so waste of time. Additional information has been requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921106 ↗
• MalfunctionSep 16, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791851 ↗
• MalfunctionSep 16, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791748 ↗
• MalfunctionApr 6, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ENDARTERECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, DR. (B)(6) COMPLAINED THAT THE PROLENE VISIBLACK NEEDLE BENDS AND THE NEEDLE COATING CAME OFF DURING DELICATE VESSEL ANASTOMOSES AND REPAIR OF VESSELS. CODE 8307H - THE ALTERNATIVE HE HAD TO USE WHILE THE 8711H WAS ON BACKORDER, THIS CODE WAS THE CLOSEST AVAILABLE TO THE 8711H. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792541 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ENDARTERECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, BLEEDING OCCURRED DURING THE ANASTOMOSIS WHEN THE THREAD BECAME DETACHED. THERE WAS NOT MUCH BLOOD LOSS BECAUSE THE SURGEON USED CLAMPS TO CLAMP. TIME WAS LOST. THERE WERE NO REAL CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291479 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ENDARTERECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, BLEEDING OCCURRED DURING THE ANASTOMOSIS WHEN THE THREAD BECAME DETACHED. THERE WAS NOT MUCH BLOOD LOSS BECAUSE THE SURGEON USED CLAMPS TO CLAMP. TIME WAS LOST. THERE WERE NO REAL CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291475 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ENDARTERECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, BLEEDING OCCURRED DURING THE ANASTOMOSIS WHEN THE THREAD BECAME DETACHED. THERE WAS NOT MUCH BLOOD LOSS BECAUSE THE SURGEON USED CLAMPS TO CLAMP. TIME WAS LOST. THERE WERE NO REAL CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291356 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAROTID ENDARTERECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, BLEEDING OCCURRED DURING THE ANASTOMOSIS WHEN THE THREAD BECAME DETACHED. THERE WAS NOT MUCH BLOOD LOSS BECAUSE THE SURGEON USED CLAMPS TO CLAMP. TIME WAS LOST. THERE WERE NO REAL CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290562 ↗
• MalfunctionSep 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY BYPASS PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. BEFORE THE VASCULAR ANASTOMOSIS SURGERY IN THE CORONARY BYPASS, THE SUTURE IS BREAKING APART FROM THE NEEDLE AND THREAD CONNECTION POINT. THE BREAKAGES HAPPENED DURING USE AND BEFORE USE ON THE PATIENT. AN ATTEMPT WAS MADE TO SOLVE THE PROBLEM WITH ANOTHER BRAND OF SUTURE, BUT THERE WAS NO PROBLEM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17838029 ↗
• MalfunctionSep 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY BYPASS PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. BEFORE THE VASCULAR ANASTOMOSIS SURGERY IN THE CORONARY BYPASS, THE SUTURE IS BREAKING FROM THE THREAD PART. THE BREAKAGES HAPPENED BOTH DURING USE AND BEFORE USE ON THE PATIENT. AN ATTEMPT WAS MADE TO SOLVE THE PROBLEM WITH ANOTHER BRAND OF SUTURE, BUT THERE WAS NO PROBLEM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17837652 ↗
• MalfunctionFeb 3, 2023Material 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 WAS SEPARATED FROM THE NEEDLE, WHICH RESULTED IN THE EXTENSION AND SEARCH FOR THE NEEDLE UP TO 1 HOUR. THE NEEDLE WAS REMOVED DURING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE CURRENT CONDITION OF THE PATIENT WAS REPORTED AS OK. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16300010 ↗
• MalfunctionJan 6, 2023Material 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 WAS SEPARATED FROM THE NEEDLE, WHICH RESULTED IN THE EXTENSION AND SEARCH FOR THE NEEDLE UP TO 1 HOUR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112048 ↗
• MalfunctionMay 26, 2022Break; Material Separation; Material Twisted/Bent; Break; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD NEEDLE JOINT IS COMING APART, THE THREAD BREAKS, AND THE NEEDLE IS BENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14503875 ↗
• MalfunctionMay 7, 2022Break; Material Separation; Material Twisted/Bent; Break; Material Separation; Material Twisted/Bent

  THREAD NEEDLE JOINT IS COMING APART. THREAD BREAKS. THE NEEDLE IS BENT. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14319101 ↗
• MalfunctionApr 29, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE THREAD BROKE WHEN PULLING THE KNOTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14252018 ↗
• MalfunctionMar 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN ATTACHING PROSTHESIS, THE SUTURE BROKE WHEN KNOTTING, CHANGE OF SUTURE FROM THE SAME BOX AND SUTURE BREAKS AGAIN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13775870 ↗
• MalfunctionMar 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN ATTACHING PROSTHESIS, THE SUTURE BROKE WHEN KNOTTING, CHANGE OF SUTURE FROM THE SAME BOX AND SUTURE BREAKS AGAIN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13775868 ↗
• MalfunctionJan 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE OPERATION, DURING THE SECOND PASS TWO SUTURES BROKE IN THE VICINITY OF THE NEEDLE THREAD CONNECTION IN AN UNUSUAL WAY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13233928 ↗
• MalfunctionJan 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE OPERATION, DURING THE SECOND PASS TWO SUTURES BROKE IN THE VICINITY OF THE NEEDLE THREAD CONNECTION IN AN UNUSUAL WAY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13233927 ↗
• MalfunctionNov 8, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775229 ↗
• MalfunctionNov 8, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775203 ↗
• MalfunctionNov 8, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775189 ↗
• MalfunctionNov 7, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KIDNEY PROCEDURE ON (B)(6) 2021 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 12760575 ↗
• MalfunctionNov 7, 2021Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2021 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 12759750 ↗

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-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• 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-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• 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-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748

…and 6 more.