PROLENE 8696GRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10705031019188), received between Apr 18, 2019 and Mar 2, 2026 — classified as 3 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. WHEN SUTURING THE WOUND DURING SURGERY, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND THE SURGERY WAS IMMEDIATELY STOPPED. THE NEEDLE AND SUTURE WERE REMOVED AND CHECKED FOR INTEGRITY, AND THE SUTURE WAS REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24488405 ↗
• MalfunctionJun 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REMOVAL SURGERY OF PIGMENTED NEVI PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR PERFORMED SURGERY ON THE PATIENT AND DURING THE SUTURING PROCESS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. IMMEDIATELY REPLACE THE SUTURE WITH A NEW ONE AND SUTURE THE WOUND SMOOTHLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358388 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEVUS INCISION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE SKIN. THE PATIENT EXPERIENCED POOR POSTOPERATIVE HEALING. WHEN REMOVING THE STITCHES 10-14 DAYS AFTER SURGERY, THE PATIENT'S WOUND WAS NOT HEALED WELL WITH REDNESS AND SWELLING. RE-SEWING WAS DONE AFTER SKIN DISINFECTION. NOW THE PATIENT IS STABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Impaired Healing; Scar Tissue; Swelling/ Edema

  MAUDE report 22344481 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEVUS INCISION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE SKIN. THE PATIENT EXPERIENCED POOR POSTOPERATIVE HEALING. WHEN REMOVING THE STITCHES 10-14 DAYS AFTER SURGERY, THE PATIENT'S WOUND WAS NOT HEALED WELL WITH REDNESS AND SWELLING. RE-SEWING WAS DONE AFTER SKIN DISINFECTION. NOW THE PATIENT IS STABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Impaired Healing; Scar Tissue; Swelling/ Edema

  MAUDE report 22344480 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEVUS INCISION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE SKIN. THE PATIENT EXPERIENCED POOR POSTOPERATIVE HEALING. WHEN REMOVING THE STITCHES 10-14 DAYS AFTER SURGERY, THE PATIENT'S WOUND WAS NOT HEALED WELL WITH REDNESS AND SWELLING. RE-SEWING WAS DONE AFTER SKIN DISINFECTION. NOW THE PATIENT IS STABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Impaired Healing; Scar Tissue; Swelling/ Edema

  MAUDE report 22344479 ↗
• MalfunctionDec 29, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. ON THREE PACKAGES FROM THIS LOT, THE NEEDLES DETACHED FROM THE SUTURE UPON SUTURE PLACEMENT THROUGH TISSUE, ON THE SAME PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18419037 ↗
• MalfunctionDec 29, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. ON THREE PACKAGES FROM THIS LOT, THE NEEDLES DETACHED FROM THE SUTURE UPON SUTURE PLACEMENT THROUGH TISSUE, ON THE SAME PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18419031 ↗
• MalfunctionDec 29, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. ON THREE PACKAGES FROM THIS LOT, THE NEEDLES DETACHED FROM THE SUTURE UPON SUTURE PLACEMENT THROUGH TISSUE, ON THE SAME PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18419030 ↗
• MalfunctionMay 26, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. ALSO, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010660 ↗
• MalfunctionMay 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. ALSO, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010652 ↗
• MalfunctionSep 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON (B)(6) 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE DURING USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414223 ↗
• MalfunctionSep 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON (B)(6) 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE DURING USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414221 ↗
• MalfunctionSep 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON (B)(6) 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE DURING USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414220 ↗
• MalfunctionSep 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON (B)(6) 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE DURING USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414217 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON (B)(6) 2020 AND AFTER OPENING THE PACKAGE, IT WAS FOUND THAT THE NEEDLE TIP WAS NOT SHARP, SO, THE NEEDLE COULD NOT BE USED. UPON EVALUATION, THE NEEDLE BREAKAGE AT THE TIP WAS OBSERVED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11817183 ↗
• MalfunctionOct 30, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON FELT THAT THE SUTURE WAS BROKEN EASILY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9256114 ↗
• MalfunctionOct 30, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON FELT THAT THE SUTURE WAS BROKEN EASILY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9256112 ↗
• MalfunctionOct 30, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON FELT THAT THE SUTURE WAS BROKEN EASILY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9256104 ↗
• MalfunctionOct 30, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON FELT THAT THE SUTURE WAS BROKEN EASILY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9256103 ↗
• MalfunctionOct 30, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON FELT THAT THE SUTURE WAS BROKEN EASILY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9256101 ↗
• MalfunctionOct 30, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON FELT THAT THE SUTURE WAS BROKEN EASILY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9256099 ↗
• MalfunctionOct 30, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON FELT THAT THE SUTURE WAS BROKEN EASILY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9256097 ↗
• MalfunctionOct 30, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON FELT THAT THE SUTURE WAS BROKEN EASILY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9256095 ↗
• MalfunctionOct 30, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON FELT THAT THE SUTURE WAS BROKEN EASILY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9256093 ↗
• MalfunctionOct 30, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON FELT THAT THE SUTURE WAS BROKEN EASILY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9256092 ↗

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-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768

…and 6 more.