PROLENE 8558HRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031017092), received between Aug 20, 2020 and Aug 28, 2026 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50498777 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24705116 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT ALL OF THE SUTURE IN THE BOX IS BRITTLE. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23731100 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT ALL OF THE SUTURE IN THE BOX IS BRITTLE. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23731096 ↗
• MalfunctionJul 17, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE FRAYED NEXT TO THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531552 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LIGHT UPPER LOBE SLEEVE LOBECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR BRONCHIAL ANASTOMOSIS. THERE WAS A SUSPECTED SUTURE FAILURE AT THE ANASTOMOSIS. EMERGENCY SURGERY WAS PERFORMED AND RIGHT PNEUMONECTOMY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose

  MAUDE report 21233297 ↗
• MalfunctionSep 23, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A WHIPPLE PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE INTO TWO PIECES WHEN USED TO CLOSE SUBCUTICULAR LAYER. IT'S A NORMAL PRACTICE FOR THIS HOSPITAL TO USE ANY REMAINING UNUSED SUTURES TO CLOSE SUPERFICIAL LAYER EVEN THOUGH IT IS ROUND BODY NEEDLE AND SO FAR, NO CASE OF NEEDLE BREAKAGE. THIS TIME THE NEEDLE BROKE INTO TWO AND ONE PART FLEW AWAY AND FELL ON THE FLOOR CAUSING PANIC IN OR. THEY REQUESTED TO INVESTIGATE IF THIS PARTICULAR NEEDLE HAS STRENGTH ISSUES. SHE UNDERSTANDS IT MAY BEND BUT NOT BREAK AND FLY AWAY. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20281155 ↗
• MalfunctionSep 22, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GRAFT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP THAT DURING THE UNKNOWN PROCEDURE THAT THE 3-0 PROLENE SUTURES WERE BREAKING OFF DURING THE CASE. THE NEEDLE KEPT POPPING OFF. THIS HAPPENED TO VARIOUS SUTURES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED AND STATING THAT THE SAME 3-0 PROLENE STYLE BROKE WHILE THEY WERE SUTURING THE GRAFT. . NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17796091 ↗
• MalfunctionJul 29, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE OF THE INSTRUMENT WAS BROKEN. THE SURGERY WAS DELAYED BY 15 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15129778 ↗
• MalfunctionApr 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2022 AND A SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE IMMEDIATELY DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14087850 ↗
• MalfunctionMar 29, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED DURING USAGE SPECIFICALLY DURING CANNULATION IN CARDIAC SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934742 ↗
• MalfunctionMar 28, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED DURING USAGE SPECIFICALLY DURING CANNULATION IN CARDIAC SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934669 ↗
• InjuryOct 8, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HAND TENDON RUPTURE REPAIR SURGERY ON UNKNOWN DATE IN 2020 AND THE SUTURE WAS USED FOR TENDON ANASTOMOSIS. SEVEN DAYS AFTER THE SURGERY, THE EDGE OF THE INCISION APPEARED WITH ERYTHEMA AND POST-OP INFLAMMATION. THE INCISION WAS OPENED IMMEDIATELY AND EDEMA OF SUBCUTANEOUS TISSUE WAS FOUND ALONG WITH SLIPPAGE OF SUTURE AND PARTIAL BROKEN SUTURE. THE SUTURE WAS REMOVED AND THE TENDON WAS ANASTOMOSED AGAIN WITH A NEW SUTURE. ONE WEEK LATER, THE INCISION HEALED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Edema; Erythema; Inflammation; Not Applicable; Swelling/ Edema

  MAUDE report 10651790 ↗
• InjuryAug 20, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AORTIC VALVE REPLACEMENT ON (B)(6) 2019 AND SUTURE WAS USED. ON (B)(6) 2020, DURING AN UNKNOWN FOLLOW-UP SURGERY, A RETAINED NEEDLE PERTAINING TO THE (B)(6) 2019 PROCEDURE WAS FOUND. IT WAS REPORTED THAT THE NEEDLE WAS NOT IDENTIFIED AS RETAINED AT THE TIME OF THE INITIAL PROCEDURE AND THE PATIENT WAS CLOSED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Not Applicable

  MAUDE report 10434131 ↗

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-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-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• 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-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844

…and 6 more.