PROLENE 8834HRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705031021051), received between May 27, 2020 and Nov 13, 2024 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE PULLED OFF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674390 ↗
• MalfunctionNov 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE PULLED OFF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664710 ↗
• MalfunctionNov 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE PULLED OFF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664470 ↗
• MalfunctionNov 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE PULLED OFF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20663598 ↗
• MalfunctionJul 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. THE NEEDLE POPPED OFF THE SUTURE. NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729229 ↗
• MalfunctionJul 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. THE NEEDLE POPPED OFF THE SUTURE. NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729227 ↗
• MalfunctionJul 5, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA OPERATION ON (B)(6) 2023 AND SUTURE WAS USED. WE HAD HUMAN OP DAYS ON THE 3RD ON THE 10TH AND ON 24. DURING THE PROCEDURES, WHEN USING THE THREADS (SUTURES IN UMBILICAL AND INGUINAL HERNIA OPERATIONS), THREADS CONSTANTLY BROKE OFF WHEN PULLED AND HAD TO BE RENEWED. THIS IS UNTYPICAL FOR THIS TYPE OF SUTURE SINCE THIS SUTURE HAS ALWAYS BEEN USED FOR SEVERAL YEARS AND OTHERWISE SUTURES HAVE ALMOST NEVER BROKEN DURING MESH IMPLANTATION, SO WE ASSUME A MATERIAL DEFECT. RUPTURE OF THE SUTURE WHEN IT WAS PULLED OUT OF THE BODY WITH ONLY SLIGHT TRACTION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17261099 ↗
• MalfunctionJul 5, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA OPERATION ON (B)(6) 2023 AND SUTURE WAS USED. WE HAD HUMAN OP DAYS ON THE 3RD ON THE 10TH AND ON 24. DURING THE PROCEDURES, WHEN USING THE THREADS (SUTURES IN UMBILICAL AND INGUINAL HERNIA OPERATIONS), THREADS CONSTANTLY BROKE OFF WHEN PULLED AND HAD TO BE RENEWED. THIS IS UNTYPICAL FOR THIS TYPE OF SUTURE SINCE THIS SUTURE HAS ALWAYS BEEN USED FOR SEVERAL YEARS AND OTHERWISE SUTURES HAVE ALMOST NEVER BROKEN DURING MESH IMPLANTATION, SO WE ASSUME A MATERIAL DEFECT. RUPTURE OF THE SUTURE WHEN IT WAS PULLED OUT OF THE BODY WITH ONLY SLIGHT TRACTION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259976 ↗
• MalfunctionJul 5, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA OPERATION ON (B)(6)2023 AND SUTURE WAS USED. WE HAD HUMAN OP DAYS ON THE (B)(6). DURING THE PROCEDURES, WHEN USING THE THREADS (SUTURES IN UMBILICAL AND INGUINAL HERNIA OPERATIONS), THREADS CONSTANTLY BROKE OFF WHEN PULLED AND HAD TO BE RENEWED. THIS IS UNTYPICAL FOR THIS TYPE OF SUTURE SINCE THIS SUTURE HAS ALWAYS BEEN USED FOR SEVERAL YEARS AND OTHERWISE SUTURES HAVE ALMOST NEVER BROKEN DURING MESH IMPLANTATION, SO WE ASSUME A MATERIAL DEFECT. RUPTURE OF THE SUTURE WHEN IT WAS PULLED OUT OF THE BODY WITH ONLY SLIGHT TRACTION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259966 ↗
• MalfunctionJul 5, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA OPERATION ON (B)(6) 2023 AND SUTURE WAS USED. WE HAD HUMAN OP DAYS ON THE 3RD ON THE 10TH AND ON 24. DURING THE PROCEDURES, WHEN USING THE THREADS (SUTURES IN UMBILICAL AND INGUINAL HERNIA OPERATIONS), THREADS CONSTANTLY BROKE OFF WHEN PULLED AND HAD TO BE RENEWED. THIS IS UNTYPICAL FOR THIS TYPE OF SUTURE SINCE THIS SUTURE HAS ALWAYS BEEN USED FOR SEVERAL YEARS AND OTHERWISE SUTURES HAVE ALMOST NEVER BROKEN DURING MESH IMPLANTATION, SO WE ASSUME A MATERIAL DEFECT. RUPTURE OF THE SUTURE WHEN IT WAS PULLED OUT OF THE BODY WITH ONLY SLIGHT TRACTION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259773 ↗
• MalfunctionJul 5, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17256247 ↗
• MalfunctionJun 30, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239287 ↗
• MalfunctionNov 23, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LOW ANTERIOR RESECTION ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE A SUTURE BROKE WHILE SUTURING THE CIRCULAR ANVIL IN PLACE. THE BREAKAGE WAS FROM THE SUTURE NOT NEEDLE. NO ADVERSE PATIENT CONSEQUENCES HAVE BEEN REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15851260 ↗
• MalfunctionNov 11, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CATARACT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN ATTEMPTING TO TIE A KNOT. THREE SUTURES FROM THIS LOT WERE ATTEMPTED WITH THE SAME OUTCOME. ANOTHER SUTURE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. ELEVEN STERILE SAMPLES WILL BE RETURNED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12798695 ↗
• MalfunctionNov 11, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CATARACT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN ATTEMPTING TO TIE A KNOT. THREE SUTURES FROM THIS LOT WERE ATTEMPTED WITH THE SAME OUTCOME. ANOTHER SUTURE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. ELEVEN STERILE SAMPLES WILL BE RETURNED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12798686 ↗
• MalfunctionNov 11, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CATARACT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN ATTEMPTING TO TIE A KNOT. THREE SUTURES FROM THIS LOT WERE ATTEMPTED WITH THE SAME OUTCOME. ANOTHER SUTURE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. ELEVEN STERILE SAMPLES WILL BE RETURNED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12798536 ↗
• MalfunctionOct 13, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10673200 ↗
• MalfunctionOct 13, 2020Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10673199 ↗
• MalfunctionMay 27, 2020Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10093901 ↗
• MalfunctionMay 27, 2020Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10093884 ↗

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-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031

…and 6 more.