PROLENE 8305HRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031014145), received between Oct 2, 2019 and Sep 30, 2026 — classified as 1 death, 13 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 30, 2026Material Separation

  It was reported that a patient underwent an unknown cardiovascular surgery on an unknown date and suture was used. During an unknown cardiovascular surgery, the needle and the suture were detached two products in a row. It was not a control release needle. The event occurred before using on the patient. Another product was used to complete the case. There were no adverse consequences to the patient. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946512 ↗
• MalfunctionSep 30, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946510 ↗
• MalfunctionNov 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE SEPARATES FROM THE NEEDLE WITHOUT ANY FORCE USED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523107 ↗
• MalfunctionMar 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE POPPED OFF AS THE SURGEON WAS HANDING THE SUTURE BACK TO THE SCRUB TECH AFTER FINISHING THEIR SUTURE LINE. THE NEEDLE WAS NOT RECOVERED. NO XRAY WAS COMPLETED. CASE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697950 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19580231 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19580177 ↗
• MalfunctionOct 2, 2023Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FOREARM IMPLANT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SURGEON USED 4 DIFFERENT SUTURES, BUT HE COMPLAINED THAT ONE OF THEM WAS WORN AND THE OTHER PRESENTED DEFECTS LIKE THE SUTURE WAS CUT OR THE NEEDLE WAS DETACHED FROM THE SUTURE. THE STAFF REPLACED THEM WITH OTHER LOT SUTURES AND FINISHED THE OPERATION. NO FRAGMENTS WERE GENERATED. THE SURGERY WAS NOT DELAYED TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17850573 ↗
• MalfunctionOct 2, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FOREARM IMPLANT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SURGEON USED 4 DIFFERENT SUTURES, BUT HE COMPLAINED THAT ONE OF THEM WAS WORN AND THE OTHER PRESENTED DEFECTS LIKE THE SUTURE WAS CUT OR THE NEEDLE WAS DETACHED FROM THE SUTURE. THE STAFF REPLACED THEM WITH OTHER LOT SUTURES AND FINISHED THE OPERATION. NO FRAGMENTS WERE GENERATED. THE SURGERY WAS NOT DELAYED TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17850567 ↗
• MalfunctionOct 2, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FOREARM IMPLANT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SURGEON USED 4 DIFFERENT SUTURES, BUT HE COMPLAINED THAT ONE OF THEM WAS WORN AND THE OTHER PRESENTED DEFECTS LIKE THE SUTURE WAS CUT OR THE NEEDLE WAS DETACHED FROM THE SUTURE. THE STAFF REPLACED THEM WITH OTHER LOT SUTURES AND FINISHED THE OPERATION. NO FRAGMENTS WERE GENERATED. THE SURGERY WAS NOT DELAYED TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17850563 ↗
• MalfunctionOct 2, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FOREARM IMPLANT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SURGEON USED 4 DIFFERENT SUTURES, BUT HE COMPLAINED THAT ONE OF THEM WAS WORN AND THE OTHER PRESENTED DEFECTS LIKE THE SUTURE WAS CUT OR THE NEEDLE WAS DETACHED FROM THE SUTURE. THE STAFF REPLACED THEM WITH OTHER LOT SUTURES AND FINISHED THE OPERATION. NO FRAGMENTS WERE GENERATED. THE SURGERY WAS NOT DELAYED TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17850554 ↗
• MalfunctionDec 14, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL RESECTION OF A SKIN MASS ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE WHEN ENTERING THE SKIN. THE NEEDLE WAS REMOVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13004221 ↗
• DeathNov 10, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions; Swelling/ Edema

  MAUDE report 12791171 ↗
• MalfunctionApr 19, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGERY OF EXCISION OF SKIN TUMOR PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686666 ↗
• MalfunctionOct 2, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC OPERATION ON (B)(6) 2019 AND A SUTURE WAS USED. IT WAS REPORTED THAT DURING SURGERY PULL OFF SUTURE NEEDLE OCCURRED. A LIKE DEVICE WAS USED TO COMPLETE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9148167 ↗

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-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746

…and 6 more.