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PROLENE W8304Recalls & reported problems

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

Quick summary

This Ethicon Prolene blue polypropylene surgical suture is used to stitch tissue during surgery. The 49 reports mostly describe the thread breaking during use, the material separating, or the needle pulling loose from the thread, sometimes with bleeding; no deaths and one injury were reported. 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
50
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10705031201736), received between Apr 9, 2024 and Sep 24, 2026 — classified as 1 injury, 49 malfunctions.

The most frequently reported specific device problem is “Break” (29 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: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 3 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 2 reportsNov 2024: 2 reportsDec 2024: 2 reportsJan 2025: 7 reportsFeb 2025: 4 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 3 reportsJul 2025: 1 reportsAug 2025: 1 reportsSep 2025: 7 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 3 reportsJan 2026: 5 reportsFeb 2026: 0 reportsMar 2026: 3 reportsApr 2026: 1 reportsMay 2026: 2 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520267
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break29
  • Material Separation19
  • Material Discolored3
  • Adverse Event Without Identified Device or Use Problem1
  • Component Missing1

Patient problems

  • No Clinical Signs, Symptoms or Conditions44
  • Hemorrhage/Blood Loss/Bleeding4
  • Erythema1
  • Impaired Healing1
  • Insufficient Information1
  • Ischemia1
  • Pocket Erosion1
  • Swelling/ Edema1

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 24, 2026Break

    It was reported that a patient underwent an Arteriovenous fistula surgery procedure on (b)(6) 2026, and suture was used. At 10:10, the operating room performed surgery on the patient. During the Arteriovenous fistula surgery, the side of the suture near the needle position broke while using vascular suture.After the doctor found that the suture was broken, he immediately removed the faulty needle from the surgical field to avoid risks, replaced the intact needle on the other side of the spool to complete the vascular anastomosis, and the surgery was successfully completed. After surgery, the patient was observed to have no adverse reactions such as foreign body residue or vascular damage.After checking the traceability information of the equipment afterwards, it was determined that the reason was that the manufacturer did not complete the smooth performance testing before leaving the factory, and the damaged needles with processing defects flowed into clinical use. Although this incident did not cause permanent damage to the patient's body, there are medical hazards such as residual foreign objects at the suture head and prolonged surgical suture time due to suture breakage. Additi

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50882618 ↗
  • MalfunctionJun 11, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTERIOVENOUS FISTULA SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. A ARTERIOVENOUS FISTULA SURGERY WAS PERFORMED ON A KIDNEY DIALYSIS PATIENT .THE SURGERY REQUIRED THE USE OF SUTURE, SO THE CHIEF SURGEON REQUESTED TO OPEN THE SUTURE . THE TOURING NURSE WENT TO THE STERILE INSTRUMENT TABLE TO CHECK THE EXTERNAL SURFACE FOR INTEGRITY AND CLAMPED IT WITH A NEEDLE HOLDER FOR LATER USE. WHEN THE CHIEF SURGEON BEGAN TO SUTURE THE PATIENT'S ARTERIOVENOUS VESSEL ANASTOMOSIS, THE NEEDLE HEAD NEED TO BE INSERTED DURING THE FIRST STITCH . THE DOCTOR DID NOT PULL HARD, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED , MAKING THE SUTURE UNUSABLE. THE CHIEF SURGEON IMMEDIATELY REQUESTED TO REPLACE THE SUTURE. THE CHIEF SURGEON TOOK OUT THE SEPARATED NEEDLE AND SUTURE AND REPLACED IT WITH A NEW ONE. THE PATIENT'S POOR PHYSICAL CONDITION RESULTED IN A SLIGHT INCREASE IN SURGICAL TIME AND INCREASED SURGICAL RISK. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25470437 ↗
  • MalfunctionMay 19, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. ANOTHER CASE WAS REPORTED BY DOCTOR. WHEN SUTURING FOR THE PATIENT, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25216040 ↗
  • MalfunctionMay 6, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) , 2026, AND SUTURE WAS USED. THE SUTURE WAS APPLIED DURING THE SURGERY, AND IT WAS EASY TO HAVE NEEDLE PULL OFF ISSUE, RESULTING IN POOR VASCULAR SUTURING AND BLEEDING. SUBSEQUENTLY, A NEW SUTURE WAS REPLACED FOR USE. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

    MAUDE report 25092551 ↗
  • MalfunctionApr 15, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LIVER TRANSPLANT PROCEDURE ON AN UNKNOWN DATE SUTURE WAS USED. THE SUTURE WAS EASILY BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24889262 ↗
  • MalfunctionMar 24, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. AT 17:00, THE DOCTOR USED SUTURE TO SUTURE THE ABDOMINAL BLOOD VESSELS OF THE PATIENT. HOWEVER, THE SUTURE BROKE AND WAS IMMEDIATELY REPLACED WITH A NEW SUTURE. THE SUTURE STILL BROKE AND WAS REPLACED THREE TIMES IN A ROW. THE PATIENT WAS IN A STATE OF MASSIVE BLOOD VESSEL RUPTURE AND BLEEDING, AND THE QUALITY OF THE SUTURE WAS LIKELY TO INCREASE THE PATIENT'S SURGICAL RISK. WHEN THE FOURTH SUTURE WAS REPLACED, THE PATIENT WAS SUCCESSFULLY SUTURED AND SAFELY GOT OFF THE OPERATING TABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 24675889 ↗
  • MalfunctionMar 24, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. AT 17:00, THE DOCTOR USED SUTURE TO SUTURE THE ABDOMINAL BLOOD VESSELS OF THE PATIENT. HOWEVER, THE SUTURE BROKE AND WAS IMMEDIATELY REPLACED WITH A NEW SUTURE. THE SUTURE STILL BROKE AND WAS REPLACED THREE TIMES IN A ROW. THE PATIENT WAS IN A STATE OF MASSIVE BLOOD VESSEL RUPTURE AND BLEEDING, AND THE QUALITY OF THE SUTURE WAS LIKELY TO INCREASE THE PATIENT'S SURGICAL RISK. WHEN THE FOURTH SUTURE WAS REPLACED, THE PATIENT WAS SUCCESSFULLY SUTURED AND SAFELY GOT OFF THE OPERATING TABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 24675865 ↗
  • MalfunctionMar 24, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. AT 17:00, THE DOCTOR USED SUTURE TO SUTURE THE ABDOMINAL BLOOD VESSELS OF THE PATIENT. HOWEVER, THE SUTURE BROKE AND WAS IMMEDIATELY REPLACED WITH A NEW SUTURE. THE SUTURE STILL BROKE AND WAS REPLACED THREE TIMES IN A ROW. THE PATIENT WAS IN A STATE OF MASSIVE BLOOD VESSEL RUPTURE AND BLEEDING, AND THE QUALITY OF THE SUTURE WAS LIKELY TO INCREASE THE PATIENT'S SURGICAL RISK. WHEN THE FOURTH SUTURE WAS REPLACED, THE PATIENT WAS SUCCESSFULLY SUTURED AND SAFELY GOT OFF THE OPERATING TABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 24675837 ↗
  • MalfunctionJan 16, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IN TRANSPLANT SURGERY, THE THREAD WAS COMING LOOSE FROM THE NEEDLE DURING THE ANASTOMOSIS. THE PROCEDURE WAS SUCCESSFUL AND WITHOUT COMPLICATIONS FOR THE PATIENT. HOWEVER, THEY HAVE TWO AFFECTED BOXES FROM THE SAME BATCH. THEY ARE REQUESTING A REPLACEMENT FOR BOTH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24095642 ↗
  • MalfunctionJan 16, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IN TRANSPLANT SURGERY, THE THREAD WAS COMING LOOSE FROM THE NEEDLE DURING THE ANASTOMOSIS. THE PROCEDURE WAS SUCCESSFUL AND WITHOUT COMPLICATIONS FOR THE PATIENT. HOWEVER, THEY HAVE TWO AFFECTED BOXES FROM THE SAME BATCH. THEY ARE REQUESTING A REPLACEMENT FOR BOTH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24095632 ↗
  • MalfunctionJan 16, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IN TRANSPLANT SURGERY, THE THREAD WAS COMING LOOSE FROM THE NEEDLE DURING THE ANASTOMOSIS. THE PROCEDURE WAS SUCCESSFUL AND WITHOUT COMPLICATIONS FOR THE PATIENT. HOWEVER, THEY HAVE TWO AFFECTED BOXES FROM THE SAME BATCH. THEY ARE REQUESTING A REPLACEMENT FOR BOTH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24095628 ↗
  • MalfunctionJan 16, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IN TRANSPLANT SURGERY, THE THREAD WAS COMING LOOSE FROM THE NEEDLE DURING THE ANASTOMOSIS. THE PROCEDURE WAS SUCCESSFUL AND WITHOUT COMPLICATIONS FOR THE PATIENT. HOWEVER, THEY HAVE TWO AFFECTED BOXES FROM THE SAME BATCH. THEY ARE REQUESTING A REPLACEMENT FOR BOTH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24095624 ↗
  • MalfunctionJan 16, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IN TRANSPLANT SURGERY, THE THREAD WAS COMING LOOSE FROM THE NEEDLE DURING THE ANASTOMOSIS. THE PROCEDURE WAS SUCCESSFUL AND WITHOUT COMPLICATIONS FOR THE PATIENT. HOWEVER, THEY HAVE TWO AFFECTED BOXES FROM THE SAME BATCH. THEY ARE REQUESTING A REPLACEMENT FOR BOTH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24095621 ↗
  • MalfunctionDec 23, 2025Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTERIOVENOUS FISTULA SURGERY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT WAS ADMITTED TO THE NEPHROLOGY DEPARTMENT DUE TO UREMIA AND UNDERWENT SURGERY AT 10:00 AM. DURING THE OPERATION, THE DOCTOR USED THE SUTURE TO ANASTOMOSE THE BLOOD VESSEL, BUT THE SUTURE BROKE. THE DOCTOR REPLACED THE SUTURE AND CONTINUED TO COMPLETE THE SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23878891 ↗
  • MalfunctionDec 22, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IN TRANSPLANT SURGERY, THE THREAD WAS COMING LOOSE FROM THE NEEDLE DURING THE ANASTOMOSIS. THE PROCEDURE WAS SUCCESSFUL AND WITHOUT COMPLICATIONS FOR THE PATIENT. HOWEVER, THEY HAVE TWO AFFECTED BOXES FROM THE SAME BATCH. THEY ARE REQUESTING A REPLACEMENT FOR BOTH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23871706 ↗
  • MalfunctionDec 4, 2025Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE BROKE DURING THE ARTERIOVENOUS FISTULA SURGERY, AFFECTING THE SURGICAL PROGRESS. TIMELY REPLACEMENT OF NEW SUTURE TO CONTINUE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23714790 ↗
  • InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RESECTION OF SUBCUTANEOUS LIPOMA ON THE RIGHT SHOULDER ON(B)(6) 2025 AND SUTURE WAS USED. AFTER UNDERGOING SURGERY, THE DOCTOR USED SUTURE FOR SURGICAL CLOSURE. THE PATIENT CAME TO THE HOSPITAL FOR A FOLLOW-UP EXAMINATION 14 DAYS AFTER SURGERY DUE TO REDNESS AND SWELLING AROUND THE WOUND, EXPOSED SUTURES, PROLONGED HEALING TIME, AND INCREASED SCAR AREA. THE PATIENT HAD INFLAMMATION AND POOR WOUND HEALING, AFTER EXAMINING THE CONDITION AND UNDERGOING SURGICAL TREATMENT, THE DOCTOR REMOVED THE SUBCUTANEOUS SUTURE AND INSTRUCTED THE PATIENT TO CHANGE DRESSING REGULARLY AND CONTINUE OBSERVATION. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Erythema; Impaired Healing; Pocket Erosion; Swelling/ Edema

    MAUDE report 22962139 ↗
  • MalfunctionSep 3, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURING BLOOD VESSELS, ONE SIDE OF NEEDLE WAS SEPARATED FROM THREAD. (DURING USING ON THE PATIENT) ALL IMPACT PRODUCTS WERE DISCARDED. NO COMPLAINT SAMPLE CAN BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22952168 ↗
  • MalfunctionSep 3, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURING BLOOD VESSELS, ONE SIDE OF NEEDLE WAS SEPARATED FROM THREAD. (DURING USING ON THE PATIENT) ALL IMPACT PRODUCTS WERE DISCARDED. NO COMPLAINT SAMPLE CAN BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22952167 ↗
  • MalfunctionSep 3, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURING BLOOD VESSELS, ONE SIDE OF NEEDLE WAS SEPARATED FROM THREAD. (DURING USING ON THE PATIENT) ALL IMPACT PRODUCTS WERE DISCARDED. NO COMPLAINT SAMPLE CAN BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22952166 ↗
  • MalfunctionSep 3, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURING BLOOD VESSELS, ONE SIDE OF NEEDLE WAS SEPARATED FROM THREAD. (DURING USING ON THE PATIENT) ALL IMPACT PRODUCTS WERE DISCARDED. NO COMPLAINT SAMPLE CAN BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22952165 ↗
  • MalfunctionSep 3, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURING BLOOD VESSELS, ONE SIDE OF NEEDLE WAS SEPARATED FROM THREAD. (DURING USING ON THE PATIENT) ALL IMPACT PRODUCTS WERE DISCARDED. NO COMPLAINT SAMPLE CAN BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22952164 ↗
  • MalfunctionSep 3, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURING BLOOD VESSELS, ONE SIDE OF NEEDLE WAS SEPARATED FROM THREAD. (DURING USING ON THE PATIENT) ALL IMPACT PRODUCTS WERE DISCARDED. NO COMPLAINT SAMPLE CAN BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22952163 ↗
  • MalfunctionAug 15, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT PATIENT UNDERWENT ARTERIOVENOUS FISTULA RECONSTRUCTION SURGERY ON (B)(6) 2025, AND SUTURE WAS USED ON THE VEIN. AT 16:00, WHEN THE DOCTOR WAS SUTURING THE VEIN DURING SURGERY, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE SUTURE WAS IMMEDIATELY REPLACED AND THE SURGERY WAS CONTINUED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22815434 ↗
  • MalfunctionJul 28, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFTING+SINGLE MAMMARY ARTERY CORONARY ARTERY BYPASS GRAFTING PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT WAS ADMITTED FOR TREATMENT AND UNDERWENT SURGERY AT 8:15 AM. THE CHIEF SURGEON PERFORMED AN ANASTOMOSIS BETWEEN THE INTERNAL MAMMARY ARTERY AND THE ANTERIOR DESCENDING BRANCH DURING THE OPERATION. AT 9:20 AM, DURING THE SUTURE PROCESS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED . AT 9:30 AM, A NEW SUTURE WAS IMMEDIATELY REPLACED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22636029 ↗

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-2465-2018 · May 7, 2018 · Terminated
    PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
  • Z-2454-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
  • Z-2457-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
  • Z-2452-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
  • Z-2455-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
  • Z-2449-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
  • Z-2460-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
  • Z-2462-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
  • Z-2461-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
  • 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-2456-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
  • Z-2451-2018 · May 7, 2018 · Terminated
    PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416

…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.