PROLENE 8824GRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031020887), received between Jul 22, 2020 and Sep 19, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2024Material Frayed; Material Frayed

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE UNRAVELING DURING PROCEDURE WAS NOTED BY SURGEON AND ASKED IT TO BE REPORTED AS A SAFER EVENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE AVAILABILITY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20261424 ↗
• MalfunctionJun 23, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. POST-OPERATIVELY, THE PATIENT HAD SURGERY ON (B)(6) 2022 AND RETURNED FOR A WOUND THAT DEHISCED ON (B)(6) 2022, THE DOCTOR DID LOOK MORE CLOSELY AT THE SUTURE AND THE KNOTS WERE INTACT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 14788689 ↗
• MalfunctionJun 21, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ABLATION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. ON (B)(6) 2022 THE PATIENT RETURNED TO THE OR FOR A WOUND THAT DEHISCED. THE DOCTOR DID LOOK MORE CLOSELY AT THE SUTURE AND HIS KNOTS WERE INTACT. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 14760907 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HIATAL AND VENTRAL HERNIA REPAIR ON (B)(6) 2020 AND THE SUTURE WAS USED. THEN ON (B)(6) 2020, THE PATIENT RETURNED WITH ABDOMINAL DEHISCENCE AND REQUIRED A REVISION SURGERY. THE SURGERY WAS DONE ON (B)(6) 2020. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 10311872 ↗

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-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• 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-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• 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

…and 6 more.