PROLENE M8557Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10705031045736), received between Aug 7, 2019 and Apr 20, 2026 — classified as 52 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON WHO REPORTED THE NEEDLE POPPED OFF THE SUTURE WITH MINIMAL TENSION X 5 STRANDS. OPENED NEW PACKAGE. AFFECTED PRODUCT WAS DISCARDED PER STAFF. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926118 ↗
• MalfunctionApr 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON WHO REPORTED THE NEEDLE POPPED OFF THE SUTURE WITH MINIMAL TENSION X 5 STRANDS. OPENED NEW PACKAGE. AFFECTED PRODUCT WAS DISCARDED PER STAFF. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926110 ↗
• MalfunctionApr 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON WHO REPORTED THE NEEDLE POPPED OFF THE SUTURE WITH MINIMAL TENSION X 5 STRANDS. OPENED NEW PACKAGE. AFFECTED PRODUCT WAS DISCARDED PER STAFF. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926104 ↗
• MalfunctionApr 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON WHO REPORTED THE NEEDLE POPPED OFF THE SUTURE WITH MINIMAL TENSION X 5 STRANDS. OPENED NEW PACKAGE. AFFECTED PRODUCT WAS DISCARDED PER STAFF. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926102 ↗
• MalfunctionApr 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON WHO REPORTED THE NEEDLE POPPED OFF THE SUTURE WITH MINIMAL TENSION X 5 STRANDS. OPENED NEW PACKAGE. AFFECTED PRODUCT WAS DISCARDED PER STAFF. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926101 ↗
• MalfunctionApr 7, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACOABDOMINAL AORTIC ANEURYSM PROCEDURE ON (B)(6)2026 AND SUTURE WAS USED. DURING THE THORACOABDOMINAL AORTIC ANEURYSM PROCEDURE, THE NEEDLES ARE BENDING AND BREAKING, AND ITS VERY HARD FOR THE SURGEON TO USE. THEY WERE BENDING, VERY SOFT, AND THEY ARE DEFORMING. THE NEEDLES WERE NOT IN PATIENT'S BODY SO THERE'S NO PATIENT CONSEQUENCES.  ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799199 ↗
• MalfunctionApr 7, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACOABDOMINAL AORTIC ANEURYSM PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE THORACOABDOMINAL AORTIC ANEURYSM PROCEDURE, THE NEEDLES ARE BENDING AND BREAKING, AND ITS VERY HARD FOR THE SURGEON TO USE. THEY WERE BENDING, VERY SOFT, AND THEY ARE DEFORMING. THE NEEDLES WERE NOT IN PATIENT'S BODY SO THERE'S NO PATIENT CONSEQUENCES.  ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799198 ↗
• MalfunctionMar 13, 2026Break

  IT WAS REPORTED THAT DURING A CARDIO VASCULAR PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE BROKE WHILE SUTURING. THEY DID NOT RETAIN ANY OF THE BROKEN SUTURES. NO DELAY OR PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590182 ↗
• MalfunctionMar 12, 2026Break

  IT WAS REPORTED THAT DURING A CARDIO VASCULAR PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE BROKE WHILE SUTURING. THEY DID NOT RETAIN ANY OF THE BROKEN SUTURES.. NO DELAY OR PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578547 ↗
• MalfunctionMar 12, 2026Break

  IT WAS REPORTED THAT DURING A CARDIO VASCULAR PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE BROKE WHILE SUTURING. THEY DID NOT RETAIN ANY OF THE BROKEN SUTURES. NO DELAY OR PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578546 ↗
• MalfunctionFeb 21, 2025Break; Material Frayed; Component Misassembled; Break; Material Frayed; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE STAFF NOTICED THE WRONG NEEDLE WAS ON THE SUTURE. ALSO, THE SUTURE APPEARED TO BE FRAYING AND BREAKING. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433020 ↗
• MalfunctionDec 18, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS BROKEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20967461 ↗
• MalfunctionNov 26, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE SUTURE WAS USED. THE SUTURE IS SUPPOSED TO BE 4-0 THE SUTURES IN THIS BOX LABELED WERE ACTUALLY 5-0. THERE WERE NO PATIENT CONSEQUENCE WAS REPORTED. THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784579 ↗
• MalfunctionOct 23, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT WHILE SETTING UP FOR AN UNKNOWN PROCEDURE, THEY OPENED A PACK OF M8557, IT WAS SUPPOSED TO BE A SIZE 4-0 AND THE SUTURES THAT WERE INSIDE THE PACK SEEMED TO BE 6-0. THE LABEL OF THE PACK STATES 4-0 BUT THEY DON'T BELIEVE THAT IS WHAT IS INSIDE, THEY THINK THE SIZING IS OFF. SALES REP DOES NOT HAVE A LOT OF INFORMATION, NO LOT NUMBER OR HOW MANY THEY HAVE. SHE KNOW THERE IS AT LEAST ONE TO SEND BACK BUT MAY BE MORE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514842 ↗
• MalfunctionMar 1, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. THE SUTURE AT THE BASE OF THE NEEDLE BROKE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18819391 ↗
• MalfunctionMar 1, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. THE SUTURE AT THE BASE OF THE NEEDLE BROKE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18819326 ↗
• MalfunctionMar 1, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. THE SUTURE AT THE BASE OF THE NEEDLE BROKE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18819174 ↗
• MalfunctionMar 1, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. THE SUTURE AT THE BASE OF THE NEEDLE BROKE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18819155 ↗
• MalfunctionDec 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTOTOMY PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE SURGEON WAS HAVING ISSUES WITH THE SUTURE SHE WAS USING. THE NEEDLE POPPED OFF OF THREE SUTURES. ONE OF THE NEEDLES POPPED OUT OF THE NEEDLE HOLDER AND THEY HAD AN UNRECONCILED COUNT. ANOTHER PACK OF SUTURE FROM A DIFFERENT LOT WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18248700 ↗
• MalfunctionDec 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTOTOMY PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE SURGEON WAS HAVING ISSUES WITH THE SUTURE SHE WAS USING. THE NEEDLE POPPED OFF OF THREE SUTURES. ONE OF THE NEEDLES POPPED OUT OF THE NEEDLE HOLDER AND THEY HAD AN UNRECONCILED COUNT. ANOTHER PACK OF SUTURE FROM A DIFFERENT LOT WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18248681 ↗
• MalfunctionDec 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTOTOMY PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE SURGEON WAS HAVING ISSUES WITH THE SUTURE SHE WAS USING. THE NEEDLE POPPED OFF OF THREE SUTURES. ONE OF THE NEEDLES POPPED OUT OF THE NEEDLE HOLDER AND THEY HAD AN UNRECONCILED COUNT. ANOTHER PACK OF SUTURE FROM A DIFFERENT LOT WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18248677 ↗
• MalfunctionApr 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE POPPED OFF FIVE TIMES DURING SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743608 ↗
• MalfunctionApr 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE POPPED OFF FIVE TIMES DURING SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743601 ↗
• MalfunctionApr 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE POPPED OFF FIVE TIMES DURING SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743594 ↗
• MalfunctionApr 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE POPPED OFF FIVE TIMES DURING SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743585 ↗

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-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• 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-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067

…and 6 more.