PROLENE 8423HRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10705031015418), received between Aug 29, 2019 and Apr 24, 2026 — classified as 42 malfunctions.

The most frequently reported specific device problem is “Material Separation” (29 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE DETACHED FROM THE NEEDLE DURING SUTURING. THERE WERE NO SURGICAL DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981554 ↗
• MalfunctionApr 24, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE DETACHED FROM THE NEEDLE DURING SUTURING. THERE WERE NO SURGICAL DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981419 ↗
• MalfunctionApr 24, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE DETACHED FROM THE NEEDLE DURING SUTURING. THERE WERE NO SURGICAL DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981397 ↗
• MalfunctionApr 24, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE DETACHED FROM THE NEEDLE DURING SUTURING. THERE WERE NO SURGICAL DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981392 ↗
• MalfunctionApr 24, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE DETACHED FROM THE NEEDLE DURING SUTURING. THERE WERE NO SURGICAL DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981378 ↗
• MalfunctionApr 24, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE DETACHED FROM THE NEEDLE DURING SUTURING. THERE WERE NO SURGICAL DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981368 ↗
• MalfunctionApr 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE NURSE WHO REPORTED PRODUCT COMPLAINT AFFECTING SEVERAL EACHES (ABOUT 3 EA) OF 2-0 PROLENE CT-1 (REF: 8423H). WHEN THE TECH WAS LOADING THEM ONTO THEN NEEDLE DRIVER THERE WAS NO ISSUE. ONCE THE SURGEON TOOK A BITE AND PULLED TENSION ON THE NEEDLE TO PULL SUTURE THROUGH THE TISSUE, THE NEEDLE POPPED OFF. THIS HAPPENED AGAIN (ABOUT 2 MORE TIMES) UNTIL THEY OPENED A FRESH BOX OF 8423H. ONCE THEY OPENED A FRESH BOX, THE ISSUES RESOLVED. NO NEGATIVE IMPACT TO PATIENT OR CASE.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860008 ↗
• MalfunctionApr 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE NURSE WHO REPORTED PRODUCT COMPLAINT AFFECTING SEVERAL EACHES (ABOUT 3 EA) OF 2-0 PROLENE CT-1 (REF: 8423H). WHEN THE TECH WAS LOADING THEM ONTO THEN NEEDLE DRIVER THERE WAS NO ISSUE. ONCE THE SURGEON TOOK A BITE AND PULLED TENSION ON THE NEEDLE TO PULL SUTURE THROUGH THE TISSUE, THE NEEDLE POPPED OFF. THIS HAPPENED AGAIN (ABOUT 2 MORE TIMES) UNTIL THEY OPENED A FRESH BOX OF 8423H. ONCE THEY OPENED A FRESH BOX, THE ISSUES RESOLVED. NO NEGATIVE IMPACT TO PATIENT OR CASE.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24859987 ↗
• MalfunctionApr 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE NURSE WHO REPORTED PRODUCT COMPLAINT AFFECTING SEVERAL EACHES (ABOUT 3 EA) OF 2-0 PROLENE CT-1 (REF: 8423H). WHEN THE TECH WAS LOADING THEM ONTO THEN NEEDLE DRIVER THERE WAS NO ISSUE. ONCE THE SURGEON TOOK A BITE AND PULLED TENSION ON THE NEEDLE TO PULL SUTURE THROUGH THE TISSUE, THE NEEDLE POPPED OFF. THIS HAPPENED AGAIN (ABOUT 2 MORE TIMES) UNTIL THEY OPENED A FRESH BOX OF 8423H. ONCE THEY OPENED A FRESH BOX, THE ISSUES RESOLVED. NO NEGATIVE IMPACT TO PATIENT OR CASE.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24859293 ↗
• MalfunctionApr 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE NURSE WHO REPORTED PRODUCT COMPLAINT AFFECTING SEVERAL EACHES (ABOUT 3 EA) OF 2-0 PROLENE CT-1 (REF: 8423H). WHEN THE TECH WAS LOADING THEM ONTO THEN NEEDLE DRIVER THERE WAS NO ISSUE. ONCE THE SURGEON TOOK A BITE AND PULLED TENSION ON THE NEEDLE TO PULL SUTURE THROUGH THE TISSUE, THE NEEDLE POPPED OFF. THIS HAPPENED AGAIN (ABOUT 2 MORE TIMES) UNTIL THEY OPENED A FRESH BOX OF 8423H. ONCE THEY OPENED A FRESH BOX, THE ISSUES RESOLVED. NO NEGATIVE IMPACT TO PATIENT OR CASE.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24859252 ↗
• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SURGEON SAID THE SUTURES WERE DISINTEGRATING/BREAKING APART WHEN HE WAS USING THEM. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606554 ↗
• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SURGEON SAID THE SUTURES WERE DISINTEGRATING/BREAKING APART WHEN HE WAS USING THEM. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606548 ↗
• MalfunctionJul 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING CONTINUOUS SUTURING, THE SUTURE WAS DETACHED FROM THE NEEDLE LIKE A CONTROL RELEASE NEEDLE, ALTHOUGH 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 19739733 ↗
• MalfunctionJul 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING CONTINUOUS SUTURING, THE SUTURE WAS DETACHED FROM THE NEEDLE LIKE A CONTROL RELEASE NEEDLE, ALTHOUGH 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 19739727 ↗
• MalfunctionJul 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING CONTINUOUS SUTURING, THE SUTURE WAS DETACHED FROM THE NEEDLE LIKE A CONTROL RELEASE NEEDLE, ALTHOUGH 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 19739724 ↗
• MalfunctionJul 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING CONTINUOUS SUTURING, THE SUTURE WAS DETACHED FROM THE NEEDLE LIKE A CONTROL RELEASE NEEDLE, ALTHOUGH 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 19739723 ↗
• MalfunctionJul 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING CONTINUOUS SUTURING, THE SUTURE WAS DETACHED FROM THE NEEDLE LIKE A CONTROL RELEASE NEEDLE, ALTHOUGH 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 19739721 ↗
• MalfunctionJul 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING CONTINUOUS SUTURING, THE SUTURE WAS DETACHED FROM THE NEEDLE LIKE A CONTROL RELEASE NEEDLE, ALTHOUGH 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 19739714 ↗
• MalfunctionJun 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON 5/24/2024 AND SUTURE WAS USED. THE SUTURE BROKE WHILE SUTURING THE MESH INTO PLACE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601074 ↗
• MalfunctionJun 3, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA REPAIR ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. STRAND OF SUTURE HAD THE NEEDLE POP OFF WHEN PASSING THROUGH THE ROBOTIC 8MM TROCAR. NEW ONE WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19449095 ↗
• MalfunctionJun 3, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA REPAIR ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. STRAND OF SUTURE HAD THE NEEDLE POP OFF WHEN PASSING THROUGH THE ROBOTIC 8MM TROCAR. NEW ONE WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19449094 ↗
• MalfunctionJun 3, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA REPAIR ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. STRAND OF SUTURE HAD THE NEEDLE POP OFF WHEN PASSING THROUGH THE ROBOTIC 8MM TROCAR. NEW ONE WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19449091 ↗
• MalfunctionJun 3, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA REPAIR ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. STRAND OF SUTURE HAD THE NEEDLE POP OFF WHEN PASSING THROUGH THE ROBOTIC 8MM TROCAR. NEW ONE WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19449090 ↗
• MalfunctionJun 3, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA REPAIR ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. STRAND OF SUTURE HAD THE NEEDLE POP OFF WHEN PASSING THROUGH THE ROBOTIC 8MM TROCAR. NEW ONE WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19449087 ↗
• MalfunctionJun 3, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA REPAIR ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. STRAND OF SUTURE HAD THE NEEDLE POP OFF WHEN PASSING THROUGH THE ROBOTIC 8MM TROCAR. NEW ONE WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19449070 ↗

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-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• 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-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995

…and 6 more.