PROLENE 8533HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031016743), received between Nov 1, 2019 and Jun 23, 2021 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED FOR ABDOMINAL CLOSURE. DURING THE PROCEDURE, THE NEEDLE FELL OFF THE SUTURE. ANOTHER LIKE DEVICE WAS USED. THERE WAS A 5 MINUTE DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050851 ↗
• MalfunctionJun 23, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED FOR ABDOMINAL CLOSURE. DURING THE PROCEDURE, THE NEEDLE FELL OFF THE SUTURE. ANOTHER LIKE DEVICE WAS USED. THERE WAS A 5 MINUTE DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050849 ↗
• MalfunctionJun 23, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED FOR ABDOMINAL CLOSURE. DURING THE PROCEDURE, THE NEEDLE FELL OFF THE SUTURE. ANOTHER LIKE DEVICE WAS USED. THERE WAS A 5 MINUTE DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050841 ↗
• MalfunctionJun 21, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE GOT DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032431 ↗
• MalfunctionJun 21, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE GOT DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032430 ↗
• MalfunctionJun 21, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE GOT DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032426 ↗
• MalfunctionMar 11, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE MATERIAL HAD PULLED AWAY FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11463655 ↗
• MalfunctionNov 1, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ANEURYSM PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS USED TO COMPLETE THE AORTIC ANEURYSM ANASTOMOSIS. FOUR DIFFERENT SUTURES WERE USED AND EACH ONE SNAPPED WHILST DOING INTRICATE WORK OF THE AORTIC ANEURYSM ANASTOMOSIS. THE CASE WAS COMPLETED USING A DIFFERENT PRODUCT. THE PATIENT WAS OKAY AFTER THE PROCEDURE HOWEVER PASSED DURING THE NIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268038 ↗
• MalfunctionNov 1, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ANEURYSM PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS USED TO COMPLETE THE AORTIC ANEURYSM ANASTOMOSIS. FOUR DIFFERENT SUTURES WERE USED AND EACH ONE SNAPPED WHILST DOING INTRICATE WORK OF THE AORTIC ANEURYSM ANASTOMOSIS. THE CASE WAS COMPLETED USING A DIFFERENT PRODUCT. THE PATIENT WAS OKAY AFTER THE PROCEDURE HOWEVER PASSED DURING THE NIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9267906 ↗
• MalfunctionNov 1, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ANEURYSM PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS USED TO COMPLETE THE AORTIC ANEURYSM ANASTOMOSIS. FOUR DIFFERENT SUTURES WERE USED AND EACH ONE SNAPPED WHILST DOING INTRICATE WORK OF THE AORTIC ANEURYSM ANASTOMOSIS. THE CASE WAS COMPLETED USING A DIFFERENT PRODUCT. THE PATIENT WAS OKAY AFTER THE PROCEDURE HOWEVER PASSED DURING THE NIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9267811 ↗
• MalfunctionNov 1, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ANEURYSM PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS USED TO COMPLETE THE AORTIC ANEURYSM ANASTOMOSIS. FOUR DIFFERENT SUTURES WERE USED AND EACH ONE SNAPPED WHILST DOING INTRICATE WORK OF THE AORTIC ANEURYSM ANASTOMOSIS. THE CASE WAS COMPLETED USING A DIFFERENT PRODUCT. THE PATIENT WAS OKAY AFTER THE PROCEDURE HOWEVER PASSED DURING THE NIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9267080 ↗

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-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748

…and 6 more.