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PROLENE HS6857HRecalls & reported problems

Ethicon, LLC · PROLENE (Polypropylene) Suture Blue Monofilament, Hemo-Seal Needle Suture, Sterile, nonabsorbable surgical suture · Class 2 · Implant

Quick summary

This Ethicon Prolene suture is a non-absorbable polypropylene thread surgeons use to close tissue. The 42 reports mostly describe the thread separating or breaking during use, along with Hemo-Seal information missing from individual packaging. There are no deaths and no injuries in these reports. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
42
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10705031232778), received between Oct 27, 2020 and Feb 9, 2026 — classified as 42 malfunctions.

The most frequently reported specific device problem is “Material Separation” (20 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 8 reportsJan 2024: 2 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 5 reportsApr 2025: 0 reportsMay 2025: 4 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 3 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 10 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202610
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Separation20
  • Break11
  • Device Markings/Labelling Problem10
  • Device Contaminated During Manufacture or Shipping1

Patient problems

  • No Clinical Signs, Symptoms or Conditions42
  • Foreign Body In Patient2
  • Insufficient Information2
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 9, 2026Device Markings/Labelling Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRIMARY PACKAGING ISSUE - HEMO-SEAL INFO WAS MISSING ON EACH OF SUTURE, IT WAS ONLY PROVIDED ONLY ON SECONDARY PACKAGING (THE MAIN BOX). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24290585 ↗
  • MalfunctionFeb 9, 2026Device Markings/Labelling Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRIMARY PACKAGING ISSUE - HEMO-SEAL INFO WAS MISSING ON EACH OF SUTURE, IT WAS ONLY PROVIDED ONLY ON SECONDARY PACKAGING (THE MAIN BOX). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24290580 ↗
  • MalfunctionFeb 9, 2026Device Markings/Labelling Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRIMARY PACKAGING ISSUE - HEMO-SEAL INFO WAS MISSING ON EACH OF SUTURE, IT WAS ONLY PROVIDED ONLY ON SECONDARY PACKAGING (THE MAIN BOX). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24290578 ↗
  • MalfunctionFeb 9, 2026Device Markings/Labelling Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRIMARY PACKAGING ISSUE - HEMO-SEAL INFO WAS MISSING ON EACH OF SUTURE, IT WAS ONLY PROVIDED ONLY ON SECONDARY PACKAGING (THE MAIN BOX). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24290574 ↗
  • MalfunctionFeb 9, 2026Device Markings/Labelling Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRIMARY PACKAGING ISSUE - HEMO-SEAL INFO WAS MISSING ON EACH OF SUTURE, IT WAS ONLY PROVIDED ONLY ON SECONDARY PACKAGING (THE MAIN BOX). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24290571 ↗
  • MalfunctionFeb 9, 2026Device Markings/Labelling Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRIMARY PACKAGING ISSUE - HEMO-SEAL INFO WAS MISSING ON EACH OF SUTURE, IT WAS ONLY PROVIDED ONLY ON SECONDARY PACKAGING (THE MAIN BOX). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24290567 ↗
  • MalfunctionFeb 9, 2026Device Markings/Labelling Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRIMARY PACKAGING ISSUE - HEMO-SEAL INFO WAS MISSING ON EACH OF SUTURE, IT WAS ONLY PROVIDED ONLY ON SECONDARY PACKAGING (THE MAIN BOX). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24290565 ↗
  • MalfunctionFeb 9, 2026Device Markings/Labelling Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRIMARY PACKAGING ISSUE - HEMO-SEAL INFO WAS MISSING ON EACH OF SUTURE, IT WAS ONLY PROVIDED ONLY ON SECONDARY PACKAGING (THE MAIN BOX). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24290563 ↗
  • MalfunctionFeb 9, 2026Device Markings/Labelling Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRIMARY PACKAGING ISSUE - HEMO-SEAL INFO WAS MISSING ON EACH OF SUTURE, IT WAS ONLY PROVIDED ONLY ON SECONDARY PACKAGING (THE MAIN BOX). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24290553 ↗
  • MalfunctionFeb 9, 2026Device Markings/Labelling Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRIMARY PACKAGING ISSUE - HEMO-SEAL INFO WAS MISSING ON EACH OF SUTURE, IT WAS ONLY PROVIDED ONLY ON SECONDARY PACKAGING (THE MAIN BOX). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24290551 ↗
  • MalfunctionOct 2, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN SUTURING THE HEART . CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL RETURN 1 ACTUAL PRODUCT AND 9 REPRESENTATIVE SAMPLES FOR ANALYSIS. ENCLOSED PLEASE FIND DEFECT PHOTOS . NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 23203786 ↗
  • MalfunctionAug 26, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPLACEMENT ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22897658 ↗
  • MalfunctionAug 26, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPLACEMENT ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22897652 ↗
  • MalfunctionAug 22, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE PRODUCT WAS USED FOR OPEN CHEST CASE ABOUT ONE MONTH AGO. THE NEEDLE SUDDENLY CAME OFF FROM THE NEEDLE-HOLDER INSIDE THE BODY CAVITY AND FELL INTO THE BODY CAVITY DURING SURGERY. THE NEEDLE HAS BEEN RETRIEVED AFTER SUTURING. NO PIECES WERE LEFT INSIDE THE PATIENT. THE CUSTOMER REQUESTED TO INVESTIGATE WHETHER THE NEEDLE WAS HELD IN THE CORRECT PLACE AND WITH THE CORRECT ACCURACY AND REQUESTED TO INVESTIGATE WHETHER THE NEEDLE HAD AN ABNORMAL SHAPE IN THE FIRST PLACE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22873512 ↗
  • MalfunctionMay 21, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY . CHANGED ANOTHER THREE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WILL BE 21 DEVICES RETURNED FOR ANALYSIS, INCLUDING 4 ACTUAL PRODUCT AND 17 STERILE PRODUCTS FROM SAME BATCH. THE SURGEON REFUSED TO USE THE REMAINING 17 STERILE PRODUCTS FROM THE SAME LOT AND THEY WILL BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22059695 ↗
  • MalfunctionMay 21, 2025Material Separation; Material Separation

    PRODUCT COMPLAINT # (B)(4) DATE SENT TO THE FDA: 5/21/2025 H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22059659 ↗
  • MalfunctionMay 21, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER THREE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WILL BE 21 DEVICES RETURNED FOR ANALYSIS, INCLUDING 4 ACTUAL PRODUCT AND 17 STERILE PRODUCTS FROM SAME BATCH. THE SURGEON REFUSED TO USE THE REMAINING 17 STERILE PRODUCTS FROM THE SAME LOT AND THEY WILL BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22059648 ↗
  • MalfunctionMay 21, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER THREE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WILL BE 21 DEVICES RETURNED FOR ANALYSIS, INCLUDING 4 ACTUAL PRODUCT AND 17 STERILE PRODUCTS FROM SAME BATCH. THE SURGEON REFUSED TO USE THE REMAINING 17 STERILE PRODUCTS FROM THE SAME LOT AND THEY WILL BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22059631 ↗
  • MalfunctionMar 19, 2025Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. THE CUSTOMER FEEDBACK THAT THE SUTURE BROKE EASILY WHEN IT WAS PULLED. CHANGED ANOTHER FOUR TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL BE 36 DEVICES RETURNED FOR ANALYSIS, INCLUDING 5 ACTUAL PRODUCTS AND 31 STERILE PRODUCTS FROM SAME BATCH. THE SURGEON REFUSED TO USE THE REMAINING 31 STERILE PRODUCTS FROM THE SAME LOT AND THEY WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21641803 ↗
  • MalfunctionMar 19, 2025Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. THE CUSTOMER FEEDBACK THAT THE SUTURE BROKE EASILY WHEN IT WAS PULLED. CHANGED ANOTHER FOUR TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL BE 36 DEVICES RETURNED FOR ANALYSIS, INCLUDING 5 ACTUAL PRODUCTS AND 31 STERILE PRODUCTS FROM SAME BATCH. THE SURGEON REFUSED TO USE THE REMAINING 31 STERILE PRODUCTS FROM THE SAME LOT AND THEY WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21641798 ↗
  • MalfunctionMar 19, 2025Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. THE CUSTOMER FEEDBACK THAT THE SUTURE BROKE EASILY WHEN IT WAS PULLED. CHANGED ANOTHER FOUR TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL BE 36 DEVICES RETURNED FOR ANALYSIS, INCLUDING 5 ACTUAL PRODUCTS AND 31 STERILE PRODUCTS FROM SAME BATCH. THE SURGEON REFUSED TO USE THE REMAINING 31 STERILE PRODUCTS FROM THE SAME LOT AND THEY WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21641797 ↗
  • MalfunctionMar 19, 2025Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. THE CUSTOMER FEEDBACK THAT THE SUTURE BROKE EASILY WHEN IT WAS PULLED . CHANGED ANOTHER FOUR TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL BE 36 DEVICES RETURNED FOR ANALYSIS, INCLUDING 5 ACTUAL PRODUCTS AND 31 STERILE PRODUCTS FROM SAME BATCH. THE SURGEON REFUSED TO USE THE REMAINING 31 STERILE PRODUCTS FROM THE SAME LOT AND THEY WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21641795 ↗
  • MalfunctionMar 19, 2025Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. THE CUSTOMER FEEDBACK THAT THE SUTURE BROKE EASILY WHEN IT WAS PULLED . CHANGED ANOTHER FOUR TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL BE 36 DEVICES RETURNED FOR ANALYSIS, INCLUDING 5 ACTUAL PRODUCTS AND 31 STERILE PRODUCTS FROM SAME BATCH. THE SURGEON REFUSED TO USE THE REMAINING 31 STERILE PRODUCTS FROM THE SAME LOT AND THEY WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21641794 ↗
  • MalfunctionJan 30, 2024Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AORTIC DISSECTION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2023 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18611417 ↗
  • MalfunctionJan 16, 2024Material 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 SUTURE WAS EASILY DETACHED FROM THE NEEDLE. 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 18520496 ↗

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-2464-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
  • Z-2458-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
  • Z-2455-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
  • Z-2466-2018 · May 7, 2018 · Terminated
    PRONOVA SUTURE BLUE 122CM M1.5, D10189
  • Z-2450-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
  • Z-2451-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
  • Z-2454-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
  • Z-2456-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
  • Z-2463-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
  • Z-2461-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
  • Z-2459-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
  • 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.

Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.