PROLENE M8706Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10705031045811), received between Mar 28, 2019 and Dec 19, 2025 — classified as 44 malfunctions.

The most frequently reported specific device problem is “Material Separation” (27 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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT EVERY BATCH OF SUTURES IS BREAKING OFF TOO EASY AND THEY'VE TAKEN IT OFF THE SHELF. NO ADVERSE IMPACT TO THE PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23855568 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT EVERY BATCH OF SUTURES IS BREAKING OFF TOO EASY AND THEY'VE TAKEN IT OFF THE SHELF. NO ADVERSE IMPACT TO THE PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853945 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING VASCULAR PROCEDURE, THERE WERE THREE SUTURES BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893245 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING VASCULAR PROCEDURE, THERE WERE THREE SUTURES BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893240 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING VASCULAR PROCEDURE, THERE WERE THREE SUTURES BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893226 ↗
• MalfunctionJul 23, 2024Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FEMORAL POP PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE CAME UNRAVELED. UNDOING THE ANASTOMOSIS. BLEEDING WAS CONTROLLED WITH CLAMPS. NEW PRODUCT OPENED. CASE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM.

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19808493 ↗
• MalfunctionJul 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KIDNEY SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF THE POLYMER. ALMOST AS IF THIS WAS A CONTROLLED RELEASE SUTURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761064 ↗
• MalfunctionJul 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KIDNEY SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF THE POLYMER. ALMOST AS IF THIS WAS A CONTROLLED RELEASE SUTURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761058 ↗
• MalfunctionAug 30, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN AV FISTULA PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE. A NEW SUTURE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17655328 ↗
• MalfunctionAug 30, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN AV FISTULA PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE. A NEW SUTURE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17655310 ↗
• MalfunctionJul 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN NEEDLE WAS PASSED THROUGH VALVE DURING ANASTOMOSIS, NEEDLE FELL OFF OF SUTURE WITH NO RESISTANCE. SCRUB TECH TOOK ADDITIONAL NEEDLE IN THE PACK AND SLIGHTLY PUSHED NEEDLE WHILE HOLDING SUTURE AND STATES IT CAME OFF AS IF IT WAS NOT CLAMPED ONTO SUTURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17366335 ↗
• MalfunctionJul 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN NEEDLE WAS PASSED THROUGH VALVE DURING ANASTOMOSIS, NEEDLE FELL OFF OF SUTURE WITH NO RESISTANCE. SCRUB TECH TOOK ADDITIONAL NEEDLE IN THE PACK AND SLIGHTLY PUSHED NEEDLE WHILE HOLDING SUTURE AND STATES IT CAME OFF AS IF IT WAS NOT CLAMPED ONTO SUTURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17366235 ↗
• MalfunctionJul 12, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE UNKNOWN PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17306740 ↗
• MalfunctionJul 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE NEEDLE POPPED OFF OF THE SUTURE. THIS HAS HAPPENED SEVERAL TIMES OVER THE LAST FEW MONTHS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302433 ↗
• MalfunctionJul 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, TWO NEEDLES POP OFF OF THE SUTURE. A THIRD SUTURE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17254582 ↗
• MalfunctionJul 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON 06/13/2023 AND SUTURE WAS USED. DURING THE PROCEDURE, TWO NEEDLES POP OFF OF THE SUTURE. A THIRD SUTURE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17254237 ↗
• MalfunctionMay 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. THIS HAPPENED IN SEVERAL PACKAGES. 6 PACKAGES WERE USED. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009863 ↗
• MalfunctionMay 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. THIS HAPPENED IN SEVERAL PACKAGES. 6 PACKAGES WERE USED. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009856 ↗
• MalfunctionMay 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. THIS HAPPENED IN SEVERAL PACKAGES. 6 PACKAGES WERE USED. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009855 ↗
• MalfunctionMay 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. THIS HAPPENED IN SEVERAL PACKAGES. 6 PACKAGES WERE USED. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009849 ↗
• MalfunctionMay 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. THIS HAPPENED IN SEVERAL PACKAGES. 6 PACKAGES WERE USED. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009844 ↗
• MalfunctionMar 21, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE BROKE MIDWAY DOWN AND LOOKED LIKE A 'PIGTAIL', NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16585271 ↗
• MalfunctionSep 29, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF OF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503774 ↗
• MalfunctionSep 29, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF OF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503508 ↗
• MalfunctionAug 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE POPPED OFF THE NEEDLE DURING SURGERY. IT IS UNKNOWN AS TO WHAT TYPE OF TISSUE WAS BEING SUTURED AT THE TIME. A NEW SUTURE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15286156 ↗

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-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• 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
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031

…and 6 more.