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
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, ClassifiedPROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
- Z-1096-2025 · Dec 20, 2024 · Open, ClassifiedPROLENE 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 · TerminatedPROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
- Z-2448-2018 · May 7, 2018 · TerminatedPROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
- Z-2465-2018 · May 7, 2018 · TerminatedPRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
- Z-2459-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
- Z-2452-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
- Z-2451-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
- Z-2458-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
- Z-2464-2018 · May 7, 2018 · TerminatedPROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
- Z-2453-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
- Z-2450-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
- Z-2457-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
- Z-2463-2018 · May 7, 2018 · TerminatedPROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
- Z-2456-2018 · May 7, 2018 · TerminatedPROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
…and 6 more.
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices
- PROLENE 8706HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 recalls294 reports
- PROLENE 8702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths254 reports
- PROLENE 8556HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death240 reports
- PROLENE 8805HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death209 reports
- PROLENE 8735HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE163 reports
- PROLENE 8711HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall89 reports
- PROLENE 9702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE130 reports
- PROLENE EP8735HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE128 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.