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PROLENE 8521HRecalls & reported problems

Ethicon, LLC · Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture · Class 2 · Implant

Quick summary

This Ethicon Prolene suture is a blue, non-absorbable thread used to close tissue during surgery, including heart surgery. Its 184 reports include 4 deaths and 1 injury. Many describe the suture breaking or splitting while surgeons sew tissue, and some describe fraying, with surgeons switching to another suture to finish. 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
183
Deaths reported
3
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 183 adverse event reports that list this exact device (DI 10705031016538), received between Dec 18, 2018 and Jun 10, 2026 — classified as 3 deaths, 1 injury, 179 malfunctions.

The most frequently reported specific device problem is “Break” (139 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: 2 reportsDec 2023: 4 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 8 reportsApr 2024: 5 reportsMay 2024: 0 reportsJun 2024: 2 reportsJul 2024: 0 reportsAug 2024: 3 reportsSep 2024: 6 reportsOct 2024: 11 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 9 reportsFeb 2025: 1 reportsMar 2025: 2 reportsApr 2025: 1 reportsMay 2025: 1 reportsJun 2025: 2 reportsJul 2025: 7 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 5 reportsFeb 2026: 0 reportsMar 2026: 4 reportsApr 2026: 0 reportsMay 2026: 2 reportsJun 2026: 2 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202611
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break139
  • Material Separation31
  • Material Frayed20
  • Defective Component1
  • Device Contaminated During Manufacture or Shipping1

Patient problems

  • No Clinical Signs, Symptoms or Conditions143
  • No Consequences Or Impact To Patient36
  • Hemorrhage/Blood Loss/Bleeding4
  • Wound Dehiscence3
  • Foreign Body In Patient2
  • Death1
  • Not Applicable1

Recent adverse event reports

The 25 most recent of 183 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 10, 2026Material Frayed

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN CABG PROCEDURE IN (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BECAME FRAYED WHILE BEING HANDLED/USED BY THE SURGEON. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25458454 ↗
  • MalfunctionJun 10, 2026Material Frayed

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN CABG PROCEDURE IN (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BECAME FRAYED WHILE BEING HANDLED/USED BY THE SURGEON. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25458450 ↗
  • MalfunctionMay 4, 2026Material Frayed

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 15/04/2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE GOT SPLIT IN THE SURGERY . CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTO. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE LOT OF IP IS UNAVAILABLE.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25071204 ↗
  • MalfunctionMay 4, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE GOT SPLIT IN THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTO. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE LOT OF IP IS UNAVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25070277 ↗
  • MalfunctionMar 26, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. THE CUSTOMER FEEDBACK THAT THE SUTURE WAS BRITTLE AND PRONE TO BREAKAGE. TOTAL 4 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL RETURN 155 REPRESENTATIVE SAMPLES FOR ANALYSIS. ENCLOSED PLEASE FIND DEFECT PHOTO. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24697686 ↗
  • MalfunctionMar 26, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. THE CUSTOMER FEEDBACK THAT THE SUTURE WAS BRITTLE AND PRONE TO BREAKAGE. TOTAL 4 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL RETURN (B)(4) REPRESENTATIVE SAMPLES FOR ANALYSIS. ENCLOSED PLEASE FIND DEFECT PHOTO. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24697682 ↗
  • MalfunctionMar 26, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. THE CUSTOMER FEEDBACK THAT THE SUTURE WAS BRITTLE AND PRONE TO BREAKAGE . TOTAL 4 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL RETURN 155 REPRESENTATIVE SAMPLES FOR ANALYSIS. ENCLOSED PLEASE FIND DEFECT PHOTO. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24697681 ↗
  • MalfunctionMar 24, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN CESAREAN EXPLORATION COLON TUMOR RESECTION SPLENECTOMY PARTIAL PANCREATECTOMY TRANSVERSE COLOSTOMY ABDOMINAL DRAINAGE PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. AT 11:55 AM, DURING THE SURGICAL ANASTOMOSIS PROCESS, AT 14:00, THE SUTURE WAS BROKEN DURING THE ANASTOMOSIS OF SPLENIC VESSELS. THE SUTURE WAS REPLACED TO CONTINUE THE SURGERY FOR THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24673701 ↗
  • MalfunctionJan 30, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO "ACUTE APPENDICITIS". DURING THE TREATMENT PROCESS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE NEW SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24223442 ↗
  • MalfunctionJan 28, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. WE HAD 4 NEEDLES BECOME DETACHED FROM THE SUTURES TODAY. THEY WERE ALL FROM LOT. THEY USED 4 SUTURES BEFORE DOCTOR GOT VERY FRUSTRATED AND WE SWITCHED TO ANOTHER BOX WITH A DIFFERENT LOT NUMBER. ANOTHER BOX WAS OPENED (DIFFERENT LOT#) AND THEY WERE OK. THERE WAS A SIGNIFICANT DELAY REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24201090 ↗
  • MalfunctionJan 28, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. WE HAD 4 NEEDLES BECOME DETACHED FROM THE SUTURES TODAY. THEY WERE ALL FROM LOT. THEY USED 4 SUTURES BEFORE DOCTOR GOT VERY FRUSTRATED AND WE SWITCHED TO ANOTHER BOX WITH A DIFFERENT LOT NUMBER. ANOTHER BOX WAS OPENED (DIFFERENT LOT#) AND THEY WERE OK. THERE WAS A SIGNIFICANT DELAY REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24201086 ↗
  • MalfunctionJan 28, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. WE HAD 4 NEEDLES BECOME DETACHED FROM THE SUTURES TODAY. THEY WERE ALL FROM LOT. THEY USED 4 SUTURES BEFORE DOCTOR GOT VERY FRUSTRATED AND WE SWITCHED TO ANOTHER BOX WITH A DIFFERENT LOT NUMBER. ANOTHER BOX WAS OPENED (DIFFERENT LOT#) AND THEY WERE OK. THERE WAS A SIGNIFICANT DELAY REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24201084 ↗
  • MalfunctionJan 28, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. WE HAD 4 NEEDLES BECOME DETACHED FROM THE SUTURES TODAY. THEY WERE ALL FROM LOT. THEY USED 4 SUTURES BEFORE DOCTOR GOT VERY FRUSTRATED AND WE SWITCHED TO ANOTHER BOX WITH A DIFFERENT LOT NUMBER. ANOTHER BOX WAS OPENED (DIFFERENT LOT#) AND THEY WERE OK. THERE WAS A SIGNIFICANT DELAY REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24201083 ↗
  • MalfunctionDec 8, 2025Break; Material Frayed; Break; Material Frayed

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE FRAYED DURING USE AND BROKE AT THE KNOT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23744096 ↗
  • MalfunctionOct 31, 2025Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CYST EXCISION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE WHEN SEWING IN THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23437028 ↗
  • MalfunctionJul 17, 2025Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ROOT ENLARGEMENT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BREAKAGE DURING KNOTTING. IT WAS REPORTED THAT TOTAL 6 PRODUCTS OCCURRED SUTURE BREAKAGE DURING KNOTTING ISSUE. CHANGED ANOTHER LOT NUMBER PRODUCT TO COMPLETE THE AORTIC ROOT ENLARGEMENT SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WILL RETURN 25 REPRESENTATIVE SAMPLES FOR ANALYSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22530373 ↗
  • MalfunctionJul 17, 2025Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ROOT ENLARGEMENT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BREAKAGE DURING KNOTTING. IT WAS REPORTED THAT TOTAL 6 PRODUCTS OCCURRED SUTURE BREAKAGE DURING KNOTTING ISSUE. CHANGED ANOTHER LOT NUMBER PRODUCT TO COMPLETE THE AORTIC ROOT ENLARGEMENT SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WILL RETURN 25 REPRESENTATIVE SAMPLES FOR ANALYSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22530368 ↗
  • MalfunctionJul 17, 2025Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ROOT ENLARGEMENT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BREAKAGE DURING KNOTTING. IT WAS REPORTED THAT TOTAL 6 PRODUCTS OCCURRED SUTURE BREAKAGE DURING KNOTTING ISSUE. CHANGED ANOTHER LOT NUMBER PRODUCT TO COMPLETE THE AORTIC ROOT ENLARGEMENT SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WILL RETURN 25 REPRESENTATIVE SAMPLES FOR ANALYSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22530367 ↗
  • MalfunctionJul 17, 2025Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ROOT ENLARGEMENT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BREAKAGE DURING KNOTTING. IT WAS REPORTED THAT TOTAL 6 PRODUCTS OCCURRED SUTURE BREAKAGE DURING KNOTTING ISSUE. CHANGED ANOTHER LOT NUMBER PRODUCT TO COMPLETE THE AORTIC ROOT ENLARGEMENT SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WILL RETURN 25 REPRESENTATIVE SAMPLES FOR ANALYSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22530366 ↗
  • MalfunctionJul 17, 2025Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ROOT ENLARGEMENT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BREAKAGE DURING KNOTTING. IT WAS REPORTED THAT TOTAL 6 PRODUCTS OCCURRED SUTURE BREAKAGE DURING KNOTTING ISSUE. CHANGED ANOTHER LOT NUMBER PRODUCT TO COMPLETE THE AORTIC ROOT ENLARGEMENT SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WILL RETURN 25 REPRESENTATIVE SAMPLES FOR ANALYSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22530365 ↗
  • MalfunctionJul 17, 2025Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ROOT ENLARGEMENT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BREAKAGE DURING KNOTTING. IT WAS REPORTED THAT TOTAL 6 PRODUCTS OCCURRED SUTURE BREAKAGE DURING KNOTTING ISSUE. CHANGED ANOTHER LOT NUMBER PRODUCT TO COMPLETE THE AORTIC ROOT ENLARGEMENT SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WILL RETURN 25 REPRESENTATIVE SAMPLES FOR ANALYSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22530364 ↗
  • MalfunctionJul 3, 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, THAT DURING AN UNKNOWN PROCEDURE THE SUTURE BROKE. NO PATIENT CONSEQUENCES. UNKNOWN NUMBER OF STERILE SAMPLES TO RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22394869 ↗
  • MalfunctionJun 2, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANASTOMOSIS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULL-OFF FROM SUTURE DURING SEWING THE VESSEL WALL, IT WAS HOLD IN THE NEEDLE HOLDER. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. PROCEDURE FINISHED WITH SAME LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22125915 ↗
  • MalfunctionJun 2, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANASTOMOSIS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULL-OFF FROM SUTURE DURING SEWING THE VESSEL WALL, IT WAS HOLD IN THE NEEDLE HOLDER. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. PROCEDURE FINISHED WITH SAME LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22125903 ↗
  • MalfunctionMay 27, 2025Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC RESECTION OF MIDDLE LOBE LIVER TUMOR+CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE LAPAROSCOPIC RESECTION OF MIDDLE LOBE LIVER TUMOR+CHOLECYSTECTOMY SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22090239 ↗

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-2462-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
  • Z-2448-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
  • 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-2452-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
  • Z-2451-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
  • Z-2458-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
  • Z-2464-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
  • 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-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-2456-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647

…and 6 more.

Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices

All SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices →

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