PROLENE 8709HRecalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 10705031019515), received between Apr 17, 2019 and May 4, 2026 — classified as 3 injuries, 92 malfunctions.

The most frequently reported specific device problem is “Material Separation” (46 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 95 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. 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 25073092 ↗
• InjuryApr 10, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IN THIS INSTANCE, THE SUTURE FAILED POST-OPERATIVELY, NECESSITATING URGENT SURGICAL REVISION. UNFORTUNATELY, THEY DID NOT KEEP THE PACKAGING /LOT# AS THE FAILURE DID NOT OCCUR AT TIME-OF-USE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24839312 ↗
• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A VASCULAR PROCEDURE THAT WHILE SUTURING THE ABDOMINAL AORTA IN THE GROIN AREA THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. UNKNOWN NUMBER STERILE SAMPLES RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037142 ↗
• MalfunctionFeb 27, 2025Material Separation; Material Separation

  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 DOCTOR BY THE NURSING COORDINATOR THAT IT DOES NOT FEEL RIGHT IN REFERENCE TO A SUTURE. HE ALSO REFERENCES THAT THE NEEDLE WAS BREAKING OFF THE SUTURE FREQUENTLY. NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT CONSEQUENCES REPORTED. DEVICE AVAILABILITY UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21482524 ↗
• MalfunctionFeb 27, 2025Material Separation; Material Separation

  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 DOCTOR BY THE NURSING COORDINATOR THAT IT DOES NOT FEEL RIGHT IN REFERENCE TO A SUTURE. HE ALSO REFERENCES THAT THE NEEDLE WAS BREAKING OFF THE SUTURE FREQUENTLY. NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT CONSEQUENCES REPORTED. DEVICE AVAILABILITY UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21482523 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SALES REP IS REPORTING FROM THE CUSTOMER THAT THE SUTURE HAD BROKEN. NO ADDITIONAL INFORMATION WAS GIVEN TO THE REP. NO PATIENT HARM REPORTED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028768 ↗
• MalfunctionOct 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SALES REP IS REPORTING FROM THE CUSTOMER THAT WHILE SUTURING THE NEEDLE HAD POPPED OFF LEAVING THEM UNSATISFIED DUE TO IT NOT BEING MADE TO DO AS SUCH. THEY WERE ABLE TO RETRIEVE AND GOT ANOTHER ONE TO COMPLETE THE CASE WITHOUT PATIENT HARM. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20571780 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT LEFT INGUINAL HERNIA REPAIR ON (B)(6) 2005 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT LEFT INGUINAL HERNIA REPAIR ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 20341042 ↗
• MalfunctionSep 5, 2024Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL FUSION PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY SALES REP THAT; THE TIP OF NEEDLE BROKE OFF. BARBS IN THE SUTURE. NEW PACK WAS OPENED TO COMPLETE THE SURGERY. THERE WAS A SURGICAL OF DELAY OF FIFTEEN MINUTES. PATIENT CONSEQUENCES UNKNOWN. DEVICE WAS NOT RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147208 ↗
• MalfunctionAug 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A VASCULAR CASE THE SUTURE BROKE TWICE WITH STANDARD TENSION TRYING TO PULL THE SUTURE THROUGH THE GRASP WHICH LED TO A SLIGHT DELAY. THEY WERE ABLE TO COMPLETE THE CASE WITH A THIRD ONE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19960193 ↗
• MalfunctionAug 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A VASCULAR CASE THE SUTURE BROKE TWICE WITH STANDARD TENSION TRYING TO PULL THE SUTURE THROUGH THE GRASP WHICH LED TO A SLIGHT DELAY. THEY WERE ABLE TO COMPLETE THE CASE WITH A THIRD ONE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19960190 ↗
• MalfunctionJul 11, 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 DETACHED EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19719254 ↗
• MalfunctionJul 11, 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 DETACHED EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19719252 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREAS-SPARING DUODENECTOMY: PSD FOR DUODENAL MUCUS MEMBRANE CARCINOMA WITH INFILTRATION INTO THE SECOND PART OF THE DUODENUM ON AN UNKNOWN DATE AND SUTURE WAS USED. THE ACCESSORY PANCREATIC DUCT WAS IDENTIFIED BY FLUORESCENCE IMAGING, AND IT WAS CLOSED WITH THE SUTURE. IT WAS RECOGNIZED THAT HE HAD A DELAYED GASTRIC EMPTYING AT 4 DAYS AFTER OPERATION AND AN INFECTION AT 6 DAYS AFTER OPERATION. THE DOCTOR ADMINISTERED ANTIBIOTICS TO THE PATIENT, AND THE PATIENT RECOVERED. IN ADDITION, NO PANCREATIC LEAKAGE OCCURRED AFTER THE OPERATION. THE PATIENT WAS DISCHARGED 44 DAYS AFTER THE OPERATION. THEREAFTER, NO SIGNS OF RECURRENCE WERE RECOGNIZED FOR 6 MONTHS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 19477356 ↗
• MalfunctionApr 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE FOUR TIMES DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 15 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153424 ↗
• MalfunctionApr 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE FOUR TIMES DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 15 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153423 ↗
• MalfunctionApr 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE FOUR TIMES DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 15 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153418 ↗
• MalfunctionApr 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE FOUR TIMES DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 15 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153407 ↗
• MalfunctionApr 19, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF OF THE SUTURE DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19144730 ↗
• MalfunctionApr 19, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN VASCULAR PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CAME OFF WITHOUT ANY TENSION EVEN BEING ON THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19144693 ↗
• MalfunctionApr 19, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON 4/9/2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF OF THE SUTURE DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143769 ↗
• MalfunctionMar 8, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. IT WAS FOUND THAT THE SUTURE WAS TORN DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866079 ↗
• MalfunctionJan 24, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AV FISTULA REVISION ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THE NEEDLE POPPED OFF THE SUTURE WITH MINIMUM FORCE APPLIED WHILE SUTURING THE ARTEGRAFT TO THE FISTULA. A NEW SUTURE LINE WAS STARTED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18577050 ↗
• MalfunctionJan 24, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AV FISTULA REVISION ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE WITH MINIMUM FORCE APPLIED WHILE SUTURING THE ARTEGRAFT TO THE FISTULA. A NEW SUTURE LINE WAS STARTED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18577046 ↗
• MalfunctionJan 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THE VASCULAR SURGEON COMPLAINED THE 6-0 PROLENE SUTURE (8805H LOT TJMRJJ) WAS BREAKING IN HALF WHEN TYING KNOTS. SURGEON SAID THAT THE SUTURE WAS BREAKING WHEN HE WOULD CINCH DOWN KNOTS. THERE WERE NO REPORTED ISSUES WITH THE NEEDLE/SUTURE CONNECTION (I.E. NO "POPPING OFF" WAS REPORTED), ONLY THAT THE SUTURE ITSELF WAS REPORTED TO BE BREAKING IN HALF WHEN UNDER TENSION. THERE WAS A 10 MINUTE DELAY. NO FRAGMENTS MADE. PROCEDURE WAS COMPLETED. NO PATIENT CONSEQUENCES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18507878 ↗

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-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• 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-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• 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-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027

…and 6 more.