PROLENE 8663GRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031018624), received between Jun 9, 2020 and Jun 14, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN STITCHING THE PATIENT, THE SUTURE PULLED AWAY FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17127149 ↗
• MalfunctionJun 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DERMATOLOGICAL PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN STITCHING A PATIENT NUMEROUS TIME, THE SUTURE WILL PULL AWAY FROM THE NEEDLE. NO PATIENT CONSEQUENCES WERE REPORTED. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122046 ↗
• MalfunctionJun 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DERMATOLOGICAL PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN STITCHING A PATIENT NUMEROUS TIME, THE SUTURE WILL PULL AWAY FROM THE NEEDLE. NO PATIENT CONSEQUENCES WERE REPORTED. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122045 ↗
• MalfunctionJun 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DERMATOLOGICAL PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN STITCHING A PATIENT NUMEROUS TIME, THE SUTURE WILL PULL AWAY FROM THE NEEDLE. NO PATIENT CONSEQUENCES WERE REPORTED. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122043 ↗
• MalfunctionMay 23, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN STITCHING THE PATIENT, THE SUTURE PULLED AWAY FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986603 ↗
• MalfunctionMay 23, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN STITCHING THE PATIENT, THE SUTURE PULLED AWAY FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986602 ↗
• MalfunctionAug 4, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THERE WAS A CONTAMINATED SUTURE; IT WAS PICKED UP BY A NURSE FOR A CASE BUT NOT OPENED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15168015 ↗
• MalfunctionApr 16, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE CUSTOMER REQUESTS PRODUCT RETURN DUE TO NOT BEING SATISFIED WITH THE PRODUCT. NEEDLES KEEP BREAKING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11680131 ↗
• MalfunctionJun 9, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPY PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE ON THE REINFORCEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10133359 ↗

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-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• 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-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995

…and 6 more.